Publications by authors named "Davood Khalili"

118 Publications

Diabetes, Hypertension, and Incidence of Chronic Kidney Disease: Is There any Multiplicative or Additive Interaction?

Int J Endocrinol Metab 2021 Jan 2;19(1):e101061. Epub 2020 Nov 2.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: The burden of chronic kidney disease (CKD) is on the rise worldwide; diabetes and hypertension are mentioned as the main contributors.

Objectives: The current study aimed to investigate the multiplicative and additive interaction of diabetes and hypertension in the incidence of CKD.

Methods: In this population-based cohort study, 7342 subjects aged 20 years or above (46.8% male) were divided into four groups: no diabetes and hypertension; diabetes and no hypertension; hypertension and no diabetes; and both diabetes and hypertension. The multivariable Cox regression was used to determine the effect of diabetes, hypertension, and their multiplicative interaction on CKD. The following indices were used to determine the additive interaction of diabetes and hypertension: the relative excess risk of interaction, the attributable proportion due to interaction, and the synergism index.

Results: Diabetes and hypertension had no significant multiplicative interaction in men (hazard ratio of 0.93, P value: 0.764) and women (hazard ratio of 0.79, P value: 0.198); furthermore, no additive interaction was found in men (relative excess risk due to interaction of 0.79, P value: 0.199; attributable proportion due to interaction of 0.22, P value: 0.130; synergy index of 1.44, P value: 0.183) and women (relative excess risk due to interaction of -0.26, P value: 0.233, attributable proportion due to interaction of -0.21, P value: 0.266; synergy index of 0.48, P value: 0.254).

Conclusions: This study demonstrated no synergic effect between diabetes and hypertension on the incidence of CKD.
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http://dx.doi.org/10.5812/ijem.101061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010431PMC
January 2021

Dynamic behavior of metabolic syndrome progression: a comprehensive systematic review on recent discoveries.

BMC Endocr Disord 2021 Mar 22;21(1):54. Epub 2021 Mar 22.

Colorectal research center, Shiraz University of Medical Sciences, Shiraz, Iran.

Background: The assessment of the natural history of metabolic syndrome (MetS) has an important role in clarifying the pathways of this disorder.

Objective: This study purposed to provide a rational statistical view of MetS progression pathway.

Methods: We performed a systematic review in accordance with the PRISMA Statement until September 2019 in the Medline/PubMed, Scopus, Embase, Web of Science and Google Scholar databases. From the 68 found studies, 12 studies were eligible for review finally.

Results: The selected studies were divided in 2 groups with Markovian and non-Markovian approach. With the Markov approach, the most important trigger for the MetS chain was dyslipidemia with overweight/obesity in the under-50 and with hypertension in the over-50 age group, where overweight/obesity was more important in women and hypertension in men. In non-Markov approach, the most common trigger was hypertension. Transition probability (TP) from no component to MetS were higher in all Markovian studies in men than in women. In the Markovians the combination of dyslipidemia with overweight/obesity and in non-Markovians, hyperglycemia with overweight/obesity were the most common combinations. Finally, the most important components, which predict the MetS, were 2-component states and hyperglycemia in Markovian approach and overweight/obesity in non-Markovians.

Conclusions: Among the components of the MetS, dyslipidemia and hypertension seems to be the main developer components in natural history of the MetS. Also, in this chain, the most likely combination over time that determines the future status of people seems to be the combination of dyslipidemia with obesity or hyperglycemia. However, more research is needed.
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http://dx.doi.org/10.1186/s12902-021-00716-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986266PMC
March 2021

Safety and efficacy of Favipiravir in moderate to severe SARS-CoV-2 pneumonia.

Int Immunopharmacol 2021 Mar 11;95:107522. Epub 2021 Mar 11.

School of Medicine, Dezful University of Medical Science, Dezful, Iran.

Background: We examined the safety and efficacy of a treatment protocol containing Favipiravir for the treatment of SARS-CoV-2.

Methods: We did a multicenter randomized open-labeled clinical trial on moderate to severe cases infections of SARS-CoV-2. Patients with typical ground glass appearance on chest computerized tomography scan (CT scan) and oxygen saturation (SpO) of less than 93% were enrolled. They were randomly allocated into Favipiravir (1.6 gr loading, 1.8 gr daily) and Lopinavir/Ritonavir (800/200 mg daily) treatment regimens in addition to standard care. In-hospital mortality, ICU admission, intubation, time to clinical recovery, changes in daily SpO after 5 min discontinuation of supplemental oxygen, and length of hospital stay were quantified and compared in the two groups.

Results: 380 patients were randomly allocated into Favipiravir (193) and Lopinavir/Ritonavir (187) groups in 13 centers. The number of deaths, intubations, and ICU admissions were not significantly different (26, 27, 31 and 21, 17, 25 respectively). Mean hospital stay was also not different (7.9 days [SD = 6] in the Favipiravir and 8.1 [SD = 6.5] days in Lopinavir/Ritonavir groups) (p = 0.61). Time to clinical recovery in the Favipiravir group was similar to Lopinavir/Ritonavir group (HR = 0.94, 95% CI 0.75 - 1.17) and likewise the changes in the daily SpO after discontinuation of supplemental oxygen (p = 0.46) CONCLUSION: Adding Favipiravir to the treatment protocol did not reduce the number of ICU admissions or intubations or In-hospital mortality compared to Lopinavir/Ritonavir regimen. It also did not shorten time to clinical recovery and length of hospital stay.
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http://dx.doi.org/10.1016/j.intimp.2021.107522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951885PMC
March 2021

Sex specific trajectories of central adiposity, lipid indices, and glucose level with incident hypertension: 12 years Follow-up in Tehran lipid and glucose study.

J Transl Med 2021 02 23;19(1):84. Epub 2021 Feb 23.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No. 24, Parvaneh Street, Velenjak, Tehran, Iran.

Aims: To identify sex specific trajectories of waist circumference (WC),triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and fasting plasma glucose (FPG) during adulthood and examine their associations with incident hypertension.

Methods: The cohort consisted of 5030 participants (2051 males) with at least 2 repeated measurement during a median of 12 years follow up. We identified trajectory groups using latent class growth mixture model, their association with hypertension was examined using multivariate Cox-regression analysis.

Results: We found 997 cases of hypertension (483 male). For both exposures, three distinct trajectory groups were identified in both genders. For WC, in women: low-increasing, 82.4%; high-stable, 13.4%; high-increasing, 4.2% and in men: stable, 94.6%; low-increasing, 3.6% and for high- increasing, 1.7%. For TG, in women: stable, 91.3%; decreasing, 5.9%; inverse U-shape, 2.8%; in men: stable, 89.7%; inverse U- shape, 6.2% and for decreasing, 4.1%. Regarding WC, high stable and high-increasing trajectories were associated with hypertension in the multivariate model [(hazard ratio (HR) = 1.66 (95% CI 1.26-2.20) and 2.78(1.79-3.60), respectively]. Among men, this association was shown only for the low-increasing trajectory [2.76: 1.49-5.10]. For TG, among women decreasing and inverse U-shape trajectories were significantly associated with hypertension in the multivariate model [1.32:1.01-1.76] and [2.23:1.58-3.23, respectively]. We did not find any impact of increasing trajectories of FPG and HDL-C on incident hypertension. Considering TC, all individuals followed a stable trajectory.

Conclusion: WC dynamic changes in both gender and TG trajectory among women were significantly associated with incident hypertension.
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http://dx.doi.org/10.1186/s12967-021-02749-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903760PMC
February 2021

Development of a risk prediction model for early discrimination between permanent and transient congenital hypothyroidism.

Endocrine 2021 Feb 22. Epub 2021 Feb 22.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objective: To develop a risk prediction model for early discrimination between transient and permanent congenital hypothyroidism (CH).

Design And Setting: In a retrospective cohort, 1047 confirmed CH neonates, from 15 randomly selected provinces in Iran, were entered to the study. Clinical and biochemical information of transient and permanent cases, distinct at the age of 3 years were retrospectively gathered.

Results: Among CH neonates, the overall prevalence of permanent CH was 57.1%. Using forward stepwise multivariable logistic regression analysis, confirmatory venous TSH, total T4 < 8.2 ng/dl, requiring levothyroxine dosage increase, venous TSH ≥ 10 mU/l between 6 and 12 months of age, parental consanguinity and family history of thyroid diseases were associated with increased risk of permanent CH. The prediction model achieved a very good power in discriminating patients with transient and permanent CH with an optimism-corrected area under the ROC curve of 0.86 (95% CI:0.84-0.88) with a very good calibration. Integrated discrimination improvement (IDI) test indicated significantly greater diagnostic performance of the model compared to serum TSH alone.

Conclusions: Using several potential predictors for permanent CH, we developed a relatively powerful risk prediction model as a cost-saving screening tool in order to avoid unnecessary long-term treatment of transient cases which might empower clinicians for prognostication of the CH course and tailoring treatment up to 1 year of age.
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http://dx.doi.org/10.1007/s12020-021-02641-0DOI Listing
February 2021

National trends in cardiovascular health metrics among Iranian adults using results of three cross-sectional STEPwise approaches to surveillance surveys.

Sci Rep 2021 Jan 8;11(1):58. Epub 2021 Jan 8.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

To examine the trends of 7 cardiovascular health metrics (CVH metrics) incorporate of smoking, physical activity, diet, body mass index (BMI), fasting plasma glucose (FPG), total cholesterol (TC), and blood pressure (BP) level during three cross-sectional STEPwise approaches to surveillance (STEPS), 2007-2016, among Iranian adults. The study population consisted of 19,841 women and 17,243 men, aged 20-65 years. The CVH metrics were categorized as 'ideal', 'intermediate', and 'poor'. The sex-stratified weighted prevalence rate of each CVH metrics was reported. The conditional probability of each poor versus combined intermediate and ideal metric was analyzed using logistic regression. In 2016 compared to 2007, the prevalence of poor BP level (20.4% vs. 23.7%), smoking (13.7% vs. 23.8%), TC ≥ 240 mg/dl (2.4% vs. 11.2%) and FPG < 100 mg/dl (75.6% vs. 82.3%) declined, whereas poor physical activity level (49.7% vs. 30%), poor healthy diet score (38.1% vs. 4.1%), BMI levels ≥ 25 kg/m (62.8% vs. 57.8%) increased. Despite a high prevalence of obesity among women, it remained constant in women but showed an increasing trend in men; moreover, the trends of low physical activity and current smoking were better for women. Despite some improvement in CVH metrics, < 4% of Iranian adults meet ≥ 6 CVH metrics in 2016; this issue needs intervention at the public health level using a multi-component strategy.
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http://dx.doi.org/10.1038/s41598-020-79322-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794314PMC
January 2021

The risk and added values of the atherosclerotic cardiovascular risk enhancers on prediction of cardiovascular events: Tehran lipid and glucose study.

J Transl Med 2021 01 6;19(1):25. Epub 2021 Jan 6.

Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: In 2013 American College of Cardiology and the American Heart Association released a guideline on the management of atherosclerotic cardiovascular disease (ASCVD) including a composite of death from CVD, non-fatal myocardial infarction, or non-fatal stroke (hard CVD). This guideline recommended a risk score that was calculated using pooled cohort equations (ASCVD-PCE). The guideline was updated in 2018/2019 and further risk discussion was suggested for deciding whether to continue or initiate statin therapy among non-diabetic individuals with ASCVD-PCE score ranged 5-20%. They recommended a risk discussion with considering risk enhancing factors (ASCVD-REFs) including family history of premature CVD, chronic kidney disease, triglycerides ≥ 175 mg/dl, low-density lipoprotein cholesterol (LDL-C) ≥ 160 mg/dl, metabolic syndrome (Mets), and for women premature menopause, and hypertensive disorders of pregnancy (HDP). In the current study, we aimed to examine the predictability of recommended ASCVD-REFs on incident hard CVD in non-diabetic individuals with LDL-C 70-189 mg/dl, with ASCVD-PCE risk 5-20% during 10 and 15-year follow-up.

Methods: Among a total of 3546 non-diabetic individuals aged 40-75 years, after excluding those with ASCVD-PCE score < 5% and ≥ 20% (n = 2342), 1204 individuals (women = 332) were included. The univariable and multivariable (further adjusted for ASCVD-PCE) Cox regression analysis were used to evaluate the association of each potential ASCVD-REFs with hard CVD. Additionnaly, the role of different components of Mets and a history of gestational diabetes (GDM)/macrosomia was also examined. The predictive ability of each significant ASCVD-REFs, then was evaluated by the discrimination accuracy and risk reclassification index.

Results: During the 10-year follow-up, 73 hard CVD events occurred. Although in univariable analysis, high blood pressure (BP) component of Mets, GDM/macrosomia, and HDP remained as significant ASCVD-REFs, in the multivariable analysis, only the history of HDP (5.35 (1.22-23.38)) and GDM/macrosomia (3.18 (1.05-9.65)) showed independent risks. During the 15-year follow-up, Mets (1.47 (1.05-2.06)) and its components of high waist circumference (1.40 (1.0-1.95)) and high BP (1.52 (1.07-2.15)) significantly increased the risk. These ASCVD-REFs did not improve discrimination or predictive ability.

Conclusions: In a decade follow-up, only conditions specific for women and in longer follow-up, the presence of Mets perse, and its components of high WC and high BP were shown as significant ASCVD-REFs.
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http://dx.doi.org/10.1186/s12967-020-02686-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789723PMC
January 2021

Estimation of the basic reproduction number (𝑅0) of the COVID-19 epidemic in Iran.

Med J Islam Repub Iran 2020 10;34:95. Epub 2020 Aug 10.

Prevention of Cardiovascular Disease Research Center, Department of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Estimation of the basic reproduction number of an infectious disease is an important issue for controlling the infection. Here, we aimed to estimate the basic reproduction number (𝑅0) of COVID-19 in Iran. To estimate 𝑅0 in Iran and Tehran, the capital, we used 3 different methods: exponential growth rate, maximum likelihood, and Bayesian time-dependent. Daily number of confirmed cases and serial intervals with a mean of 4.27 days and a standard deviation of 3.44 days with gamma distribution were used. Sensitivity analysis was performed to show the importance of generation time in estimating 𝑅0. The epidemic was in its exponential growth 11 days after the beginning of the epidemic (Feb 19, 2020) with doubling time of 1.74 (CI: 1.58-1.93) days in Iran and 1.83 (CI: 1.39-2.71) in Tehran. Nationwide, the value of 𝑅0 from February 19 to 29 using exponential growth method, maximum likelihood, and Bayesian time-dependent methods was 4.70 (95% CI: 4.23-5.23), 3.90 (95% CI: 3.47- 4.36), and 3.23 (95% CI: 2.94-3.51), respectively. In addition, in Tehran, 𝑅0 was 5.14 (95% CI: 4.15-6.37), 4.20 (95% CI: 3.38-5.14), and 3.94 (95% CI: 3.45-4.40) for exponential growth, maximum likelihood, and Bayesian time-dependent methods, respectively. Bayesian time dependent methods usually provide less biased estimates. The results of sensitivity analyses demonstrated that changes in the mean generation time affect estimates of 𝑅0. The estimate of 𝑅0 for the COVID-19 ranged from 3.94 to 5.14 in Tehran and from 3.23 to 4.70 in nationwide using different methods, which were significantly larger than 1, indicating the potential of COVID-19 to cause an outbreak.
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http://dx.doi.org/10.34171/mjiri.34.95DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722950PMC
August 2020

Trends of low physical activity among Iranian adolescents across urban and rural areas during 2006-2011.

Sci Rep 2020 12 7;10(1):21318. Epub 2020 Dec 7.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P.O. Box: 19395-4763, Tehran, Islamic Republic of Iran.

It is well documented that physical inactivity is related to weight gain and a whole host of chronic diseases. This study investigated trends of low physical activity among Iranian adolescents in urban and rural areas between 2006-2011. A total of 12,178 adolescents, aged between 15 and 19 years, participated in National Surveys of Risk Factors for Non-Communicable Diseases. Data on physical activity was obtained using the global physical activity questionnaire. A complex sample survey and multinomial logistic regression were used to model physical activity levels. The percentage of adolescents who had low levels of physical activity increased from 2006 to 2011 in both urban and rural areas. Low and moderate levels of physical activity were lower in rural girls as compared with urban girls, with a prevalence ratio of 0.59 (95% CI 0.47-0.74) and 0.59 (95% CI 0.47-0.74), respectively. The corresponding values for boys residing in rural areas compared with boys in urban areas were 0.56 (95% CI 0.43-0.75) and 0.60 (95% CI 0.48-0.74), respectively. The adolescents' lifestyles showed an increasing trend for physical inactivity in both genders; however, in rural areas, only girls had a rising affinity for a sedentary lifestyle throughout the 2006-2011 years.
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http://dx.doi.org/10.1038/s41598-020-78048-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7721745PMC
December 2020

Knowledge, Attitude, and Practice Regarding Cardiovascular Diseases in Adults Attending Health Care Centers in Tehran, Iran.

Int J Endocrinol Metab 2020 Jul 1;18(3):e101612. Epub 2020 Oct 1.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Studies on knowledge, attitude, and practice (KAP) can be valuable for public health to help in developing targeted educational programs and assessing the effectiveness of interventional programs.

Objectives: This study was designed to determine the level of current knowledge, attitude, and practice (KAP) regarding cardiovascular diseases (CVDs), CVD risk factors and symptoms in adults attending health care centers in Tehran province.

Methods: A cross-sectional study was performed using a self-administered questionnaire with score of 0 - 100 on adults aged > 20 years attending ten health care centers in Tehran province, Iran. Descriptive and multivariate logistic regression analyses were used in data analysis.

Results: A total of 300 adults (51.3% females) with a mean age of 39.71 ± 12.1 years participated in this study. The median (IQR) score for knowledge about CVD was 91.7 (16.7); approximately 80% of respondents' awareness was highly satisfactory and hypertension was the commonest identified risk factor followed by obesity. Furthermore, the median (IQR) score for attitude was 89 (18); 70% of respondents had a highly satisfactory attitude about CVD. Regarding physical activity and nutrition/smoking behaviors, just 10.7% and 32% had highly satisfactory behavior, respectively. In the multivariate logistic regression analysis, attending university education and age ≥ 40 years were independent factors of a better level of CVD knowledge; attending university education, and having a family history of chronic disease were independent factors of a better level of CVD attitude. Regarding a higher physical activity behavior, being a man, and for a better nutrition & smoking behavior, attending university education were the only independent factors.

Conclusions: Although more than half of the current study participants had high knowledge and attitude about CVD, their behaviors is not satisfactory. Therefore, it is necessary to establish more effective educational interventions aimed at promoting positive health behaviors and explaining to the public that knowledge and action regarding the reduction of risk factors are linked to reduced CVD and mortality.
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http://dx.doi.org/10.5812/ijem.101612DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7695352PMC
July 2020

Iranian general populations' and health care providers' preferences for benefits and harms of statin therapy for primary prevention of cardiovascular disease.

BMC Med Inform Decis Mak 2020 11 4;20(1):288. Epub 2020 Nov 4.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: The use of statins for primary prevention of cardiovascular diseases is associated with different benefit and harm outcomes. The aime of this study is how important these outcomes are for people and what people's preferences are.

Methods: We conducted a preference-eliciting survey incorporating a best-worst scaling (BWS) instrument in Iran from June to November 2019. The relative importance of 13 statins-related outcomes was assessed on a sample of 1085 participants, including 913 general population (486 women) and 172 healthcare providers from the population covered by urban and rural primary health care centers. The participants made trade-off decisions and selected the most and least worrisome outcomes concurrently from 13 choice sets; each contains four outcomes generated using the balanced incomplete block design.

Results: According to the mean (SD) BWS scores, which can be (+ 4) in maximum and (- 4) in minimum, in the general population, the most worrisome outcomes were severe stroke (3.37 (0.8)), severe myocardial infarction (2.71(0.7)), and cancer (2.69 (1.33)). While myopathy (- 3. 03 (1.03)), nausea/headache (- 2.69 (0.94)), and treatment discontinuation due to side effects (- 2.24 (1.14)) were the least worrisome outcomes. Preferences were similar between rural and urban areas and among health care providers and the general population with overlapping uncertainty intervals.

Conclusion: The rank of health outcomes may be similar in various socio-cultural contexts. The preferences for benefits and harms of statin therapy are essential to assess benefit-harm balance when recommending statins for primary prevention of cardiovascular diseases.
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http://dx.doi.org/10.1186/s12911-020-01304-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640674PMC
November 2020

Long-term incidence of cardiovascular outcomes in the middle-aged and elderly with different patterns of physical activity: Tehran lipid and glucose study.

BMC Public Health 2020 Nov 4;20(1):1654. Epub 2020 Nov 4.

Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Following the global upward trend of cardiovascular diseases (CVD/CHD), much attention has been paid to lifestyle behaviors such as physical activity (PA). However, most of previous studies were conducted in developed countries and with just one measurement of physical activity. The aim of the current study is to assess the effect of changes in the PA on the incidence of CVD/CHD in middle-aged and older men and women in an Eastern-Mediterranean population, over a decade follow-up.

Methods: This study has been conducted within the framework of the Tehran Lipid and Glucose Study (TLGS) including 4073 (57% women) participants without CVD/CHD at baseline. The participants were followed up for an average period of 12 years. The Iranian version of Modified Activity Questionnaire (MAQ) was used to measure PA at baseline and at the closest follow-up to the outcome. Subsequently, participants were categorized as "compliers", "non-compliers", "adopters" and "relapsers", based on their adherence to the PA guideline recommendations. All analysis has been conducted in two separate age groups including middle-aged and elderly in both men and women. The effect of PA patterns on incidence of CVD/CHD was investigated using Cox proportional hazard model. Variables including marital status, job status, education, smoking, and family history of CVD/CHD were adjusted in the models.

Results: Adherence to guideline recommendation increased from 63.5 to 66.6% between the two measurements. At the second measurement of PA, the percentages of compliers, non-compliers, adopters and relapsers were 48.4, 18.3, 18.2, and 15.1%, respectively. In fully adjusted models, HRs of CVD and CHD for men aged 40-60 years in the complier group were 0.58 (95% CI: 0.38-0.87, P = 0.008) and 0.58 (95% CI: 0.38-0.89, P = 0.01), respectively. HRs of CVD and CHD for men aged 40-60 years in adopter group were 0.61 (95% CI: 0.38-0.96, P = 0.03) and 0.60 (95% CI: 0.37-0.97, P = 0.04) respectively. The corresponding values were not significant in women.

Conclusions: Adhering to established PA recommendations have a protective effect on the incidence of CVD/CHD among middle-aged men; findings which need to be considered in reducing cardiovascular outcomes in this population.
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http://dx.doi.org/10.1186/s12889-020-09747-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640494PMC
November 2020

Assessment of the simultaneous effect of hypothyroidism and thyroid autoimmunity with gestational diabetes on the incidence of type 2 diabetes.

BMC Endocr Disord 2020 Oct 1;20(1):150. Epub 2020 Oct 1.

Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P.O. Box: 19395-4763, Tehran, Iran.

Introduction: Despite the evidence available on the adverse impact of gestational diabetes (GDM) and thyroid disorders on developing type 2 diabetes (T2DM), the concurrent influence of these disorders on the incidence of T2DM has not been reported yet.

Methods: In this prospective study, 1894 non-diabetic women aged 20 to 60 years, with a history of at least one term delivery, without diagnosed hyperthyroidism were selected at the initiation of the Tehran Thyroid Study (TTS). Pooled logistic regression analyses were used to investigate the association of GDM, thyroid disorders i.e., hypothyroidism and/or thyroid peroxidase antibody (TPOAb) positivity and interaction between GDM and thyroid disorders with the risk of incident T2DM.

Results: Of the 1894 participants of the present study, 346 (18.3%) had a history of GDM, and 832 (43.9%) had thyroid disorders. The total cumulative incidence rate of T2DM at the median follow-up time of ~ 12 years was overall 12/1000 person-years (95% confidence interval (CI): 10/1000-13/1000), with an incidence rate of 16/1000 (95%CI: 13/1000-20/1000) in women with GDM; and 11/100,000 (95%CI: 9/100,000-12/1000) among those without GDM. After adjustment for age, the risk of incident T2DM increased among individuals with the previous GDM compared to women without a history of GDM (odds ratio (OR): 1.54, 95%CI: 1.06, 2.25). No significant associations were found between either thyroid disorders or the interaction between GDM and thyroid disorders with the development of T2DM; (OR: 1.14, 95%CI: 0.82, 1.58) and (OR: 1.27, 95%CI: 0.66, 2.43), respectively.

Conclusion: GDM and thyroid disorders have no concurrent impacts on the incidence of T2DM.
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http://dx.doi.org/10.1186/s12902-020-00627-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528385PMC
October 2020

Effectiveness of Echium amoenum on premenstrual syndrome: a randomized, double-blind, controlled trial.

BMC Complement Med Ther 2020 Sep 29;20(1):295. Epub 2020 Sep 29.

Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, P.O.Box: 1419733171, Mirkhani St., Tohid Sq, Tehran, Iran.

Background: The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo.

Methods: The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups.

Results: Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively.

Conclusion: Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome.

Trial Registration: IRCT2015110822779N3 ; Registration date: 2015-11-27.
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http://dx.doi.org/10.1186/s12906-020-03084-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526142PMC
September 2020

The association of dietary macronutrients composition with the incidence of cardiovascular disease, using iso-energetic substitution models: Tehran lipid and glucose study.

Nutr Metab Cardiovasc Dis 2020 11 23;30(12):2186-2193. Epub 2020 Jul 23.

Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background And Aims: Dietary macronutrient composition plays an important role in the prevention of cardiovascular disease (CVD). This study aimed at assessing the iso-energetic substitution of dietary macronutrients in relation to the incidence of CVD.

Materials And Results: This prospective study was conducted on 5102 individuals of Tehran lipid and glucose study participants, aged 20-70 years who were followed for 5.3 years. A valid and reliable semi-quantitative food frequency questionnaire was used to assess dietary intakes. The hazard ratio of CVD for each 5% of energy from macronutrients at the expense of another macronutrient was calculated using the substitution model. During follow-up, a total of 206 CVD outcomes were identified. Mean age of participants (44.2% men) was 47.0 ± 12 and 45.6 ± 11 for men and women, respectively. Substituting 5% of energy from all types of macronutrients by 5% percentage of energy from combined saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA) was associated with a decrease in the risk of CVD by almost 20%. Higher energy intake from total-, starchy-, and nonstarchy carbohydrates replaced by other macronutrients was not significantly associated with the risk of CVD. Each 5% of energy from animal protein (HR: 1.09 and CI: 1.02-1.16) independently increased the risk of CVD in the adjusted Cox proportional hazard regression analyses.

Conclusion: Higher percentage of energy from animal protein independently increased the risk of CVD, replacement of SFA and MUFA together with other macronutrients was inversely associated with CVD risk.
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http://dx.doi.org/10.1016/j.numecd.2020.07.017DOI Listing
November 2020

Correction To: Sex-Specific Incidence Rates and Risk Factors for Hypertension During 13 Years of Follow-up: The Tehran Lipid and Glucose Study.

Glob Heart 2020 Jul 29;15(1):49. Epub 2020 Jul 29.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, IR.

[This corrects the article DOI: 10.5334/gh.780.].
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http://dx.doi.org/10.5334/gh.847DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413166PMC
July 2020

Effects of oral contraceptives on the quality of life of women with polycystic ovary syndrome: a crossover randomized controlled trial.

Health Qual Life Outcomes 2020 Aug 31;18(1):293. Epub 2020 Aug 31.

Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No 24, Parvane Street, Yaman Street, Velenjak, Tehran, Iran.

Background And Objective: A limited number of studies have evaluated the effects of oral contraceptives (OCs) on the quality of life (QOL) of polycystic ovary syndrome (PCOS) patients. This study aimed to compare the effects of using OCs containing levonorgestrel (LNG) and those containing desogestrel (DSG), cyproterone acetate (CPA) or drospirenone (DRSP) for 6 months on the QOL with PCOS.

Methods: In this crossover randomized controlled 6-arm trial, 200 eligible patients with PCOS scheduled for OC therapy were randomly assigned to one of the 6 study arms. All 6 arms include two 6-month treatment periods, one period with OCs containing LNG, and the other with each of the 3 OCs containing DSG, CPA, or DRSP. Outcomes of interest were the total score of QOL and its domains, which were assessed using a specific and valid health-related quality of life questionnaire for PCOS, which is consisted of six domains, including psychosocial-emotional, self-image, fertility, sexual function, hirsutism, and obesity- menstrual disorders.

Results: Finally, a total of 88 patients were analyzed for this study. The results showed that use of OCs containing DSG, CPA, and DRSP for 3 months was not associated with significant differences in the total scores of QOL compared to those OCs containing LNG, whereas, after 6 months of treatment, patients treated with OCs containing CPA had more improvements in their total scores of QOL, in comparison to OCs containing LNG (P < 0.042). We found no significant differences in QoL domains, including psychosocial-emotional, self-image, fertility, sexual function, hirsutism, and obesity-menstrual disorders after 3-6 months of treatment with DSG, CPA, or DRSP, compared to LNG. The sequence and period effects were not significant in any of the analyses at 3 and 6 months of treatment. The carry-over effect was not significant for most outcomes assessed.

Conclusions: This crossover study demonstrated non-inferiority of OCs with newer generation progestins on different domains of QOL, in comparison with older compounds, although usage of products containing CPA was significantly associated with more improvement in total QOL of PCOS patients, compared to those containing LNG after 6-month of treatment.

Trial Registration: IRCT201702071281N2 .
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http://dx.doi.org/10.1186/s12955-020-01544-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7460764PMC
August 2020

Estimation of Generalized Impact Fraction and Population Attributable Fraction of Hypertension Based on JNC-IV and 2017 ACC/AHA Guidelines for Cardiovascular Diseases Using Parametric G-Formula: Tehran Lipid and Glucose Study (TLGS).

Risk Manag Healthc Policy 2020 5;13:1015-1028. Epub 2020 Aug 5.

Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

Purpose: An area of interest to health policymakers is the effect of interventions aimed at risk factors on decreasing the number of new cardiovascular disease (CVD) cases. The aim of this study was to estimate the generalized impact fraction (GIF) and population attributable fraction (PAF) of hypertension (HTN) for CVD in Tehran.

Patients And Methods: In this population-based cohort study, 8071 participants aged ≥30 years were followed for a median of 16 years. A survival model was used to estimate the 10- and 18-year risk of CVD. JNC-IV and 2017 ACC/AHA guidelines were used to categorize blood pressure (BP). PAF and GIF were estimated in different scenarios using the parametric G-formula.

Results: Of 7378 participants included in analyses, 22.7% and 52.3% were classified as hypertensive according to the JNC-IV and 2017 ACC/AHA guidelines, respectively. According to the 2017 ACC/AHA, the 10-year risk of CVD was 5.1% (4.3-6.0%), 8.9% (6.7-12.0%), and 7.1% (6.1-8.4%) for normal BP, elevated BP, and stage 1 HTN, respectively, and 20.8% (18.8-23.0%) for stage 2 of the 2017 ACC/AHA and JNC-IV. The PAF of stage 2 vs stage 1 and vs normal BP for CVD was 17.4% (11.5-21.8%) and 20.4% (14.6-26.4%), respectively. The GIF of 30% reduction in the prevalence of stage 2 HTN to stage 1 and to normal BP for CVD was 5.1% (3.4-6.6%) and 6.1% (4.4-8.0%), respectively. Based on JNC-IV, the PAF and GIF of 30% for CVD were 17.8% (12.7-22.9%) and 5.4% (4.0-6.9%), respectively.

Conclusion: By reducing the prevalence of HTN by 30%, a remarkable number of new CVD cases would be prevented. In an Iranian population, the comparison of HTN cases with normal BP showed no association between stage 1 HTN and CVD, whereas elevated BP was a significant risk factor for the incidence of CVD.
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http://dx.doi.org/10.2147/RMHP.S265887DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431169PMC
August 2020

Long-term effectiveness of a lifestyle intervention on the prevention of type 2 diabetes in a middle-income country.

Sci Rep 2020 08 25;10(1):14173. Epub 2020 Aug 25.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, P O Box: 19395-4763, Tehran, Iran.

This study aims to assess the effects of a community-based lifestyle intervention program on the incidence of type 2 diabetes (T2D). For this purpose, three communities in Tehran were chosen; one community received a face-to-face educational session embedded in a long-term community-wide lifestyle intervention aimed at supporting lifestyle changes. We followed up 9,204 participants (control: 5,739, intervention: 3,465) triennially from 1999 to 2015 (Waves 1-5). After a median follow-up of 3.5 years (wave 2), the risk of T2D was 30% lower in the intervention community as compared with two control communities by (Hazard-ratio: 0.70 [95% CI 0.53; 0.91]); however, the difference was not statistically significant in the following waves. After a median follow-up of 11.9 years (wave 5), there was a non-significant 6% reduction in the incidence of T2D in the intervention group as compared to the control group (Hazard-ratio: 0.94 [0.81, 1.08]). Moreover, after 11.9 years of follow-up, the intervention significantly improved the diet quality measured by the Dietary Approaches to Stop Hypertension concordance (DASH) score. Mean difference in DASH score in the intervention group versus control group was 0.2 [95% CI 0.1; 0.3]. In conclusion, the intervention prevented T2D by 30% in the short-term (3.5 years) but not long-term; however, effects on improvement of the diet maintained in the long-term.Registration: This study is registered at IRCT, a WHO primary registry ( https://irct.ir ). The registration date 39 is 2008-10-29 and the IRCT registration number is IRCT138705301058N1.
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http://dx.doi.org/10.1038/s41598-020-71119-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447773PMC
August 2020

Effect of Bedtime Melatonin Administration in Patients with Type 2 Diabetes: A Triple-Blind, Placebo-Controlled, Randomized Trial.

Iran J Pharm Res 2019 ;18(Suppl1):258-268

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran .

Melatonin is widely available as over the counter product. Despite promising effects of melatonin supplementation on glycemic control, there is a significant heterogeneity between studies. The current study aimed at determining the effect of melatonin on fasting blood glucose (FBG), insulin resistance/sensitivity indices, glycosylated hemoglobin A1c (HbA1c), and high sensitivity C-reactive protein (hs-CRP) among type 2 diabetes mellitus (T2D) population during 8 weeks in a randomized, triple-blind, placebo-controlled trial. Thirty four subjects with the mean age ± standard deviation of 57.74 ± 8.57 years and 36 subjects with the mean age of 57.61 ± 9.11 years were allocated to 6 mg nightly melatonin and placebo groups, respectively. Melatonin and placebo groups were matched by age, gender, body mass index, and duration of diabetes. Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%, =0.042). After trial completion, the increase of serum levels of melatonin was greater in the intervention than the placebo group (3.38 ± 1.33 vs 0.94 ± 1.28 ng/L, =0.192). Moreover, compared to placebo group, among melatonin users, homeostasis model assessment of insulin resistance (HOMA1-IR) tended to be unfavorable at the end of follow-up [-0.51 (-1.76-0.81) vs. 0.28 (-1.24-1.74), =0.20]; the similar trend was also shown for insulin sensitivity index (HOMA1-S) [2.33 (-3.59-12.46) vs. -2.33 (-10.61-9.16), =0.148]. No differences were observed in FBG, HbA1C, and hs-CRP changes between the trial groups. The current study did not support the improving effect of melatonin on glucose homeostasis.
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http://dx.doi.org/10.22037/ijpr.2019.112011.13485DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393042PMC
January 2019

Estimating COVID-19-Related Infections, Deaths, and Hospitalizations in Iran Under Different Physical Distancing and Isolation Scenarios.

Int J Health Policy Manag 2020 Aug 1. Epub 2020 Aug 1.

Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.

Background: Iran is one of the first few countries that was hit hard with the coronavirus disease 2019 (COVID-19) pandemic. We aimed to estimate the total number of COVID-19 related infections, deaths, and hospitalizations in Iran under different physical distancing and isolation scenarios.

Methods: We developed a susceptible-exposed-infected/infectious-recovered/removed (SEIR) model, parameterized to the COVID-19 pandemic in Iran. We used the model to quantify the magnitude of the outbreak in Iran and assess the effectiveness of isolation and physical distancing under five different scenarios (A: 0% isolation, through E: 40% isolation of all infected cases). We used Monte-Carlo simulation to calculate the 95% uncertainty intervals (UIs).

Results: Under scenario A, we estimated 5 196 000 (UI 1 753 000-10 220 000) infections to happen till mid-June with 966 000 (UI 467 800-1 702 000) hospitalizations and 111 000 (UI 53 400-200 000) deaths. Successful implantation of scenario E would reduce the number of infections by 90% (ie, 550 000) and change the epidemic peak from 66 000 on June 9, to 9400 on March 1, 2020. Scenario E also reduces the hospitalizations by 92% (ie, 74 500), and deaths by 93% (ie, 7800).

Conclusion: With no approved vaccination or therapy available, we found physical distancing and isolation that include public awareness and case-finding and isolation of 40% of infected people could reduce the burden of COVID-19 in Iran by 90% by mid-June.
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http://dx.doi.org/10.34172/ijhpm.2020.134DOI Listing
August 2020

Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial.

J Complement Integr Med 2020 Jul 8. Epub 2020 Jul 8.

Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

Background Premenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS. Methods The present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used. Results Eventually, sixty-seven 18-35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively. Conclusion Results of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.
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http://dx.doi.org/10.1515/jcim-2019-0077DOI Listing
July 2020

Trends in cardiovascular risk factors in diabetic patients in comparison to general population in Iran: findings from National Surveys 2007-2016.

Sci Rep 2020 07 16;10(1):11724. Epub 2020 Jul 16.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, No. 23, Parvaneh Street, Velenjak, Tehran, Iran.

To determine levels of change in risk factors for cardiovascular disease among people with and without a previous diagnosis of diabetes from 2007 to 2016 in Iran. Data were obtained from five rounds of the World Health Organization STEPwise approach to Surveillance (STEPS) cross-sectional surveys. Participants were 7665 and 93,733 adults with and without known diabetes, respectively, aged 25-65 years. We used logistic and linear regressions to assess the trends of risk factors. Individuals with known diabetes compared to those without the condition, experienced greater reductions in mean levels of systolic blood pressure (3.0 vs. 0.5 mmHg among women and 3.9 vs. 1.6 mmHg among men), diastolic blood pressure (6.4 vs. 5.11 mmHg in women and 3.3 vs. 1.8 mmHg in men), and non-HDL cholesterol (42.4 vs. 27.2 mg/dL among women and 30.3 vs. 21.0 mg/dL among men) throughout these years. Men with diabetes also showed a greater reduction in the prevalence of daily cigarette smoking compared to their non-diabetic counterparts (7.3% vs. 2.3%). Fasting plasma glucose decreased among subjects with diabetes but increased among those without diabetes. Significant increases were observed in proportions who met goals for blood pressure, triglycerides, non-HDL cholesterol and LDL cholesterol in both groups; however, almost half of diabetic subjects did not achieve risk factor goals in 2016. Secondary prevention in diabetic patients was more effective than primary prevention in the general population; however, the rate of diabetic patients who met the designated goals for each risk factor was still suboptimal.
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http://dx.doi.org/10.1038/s41598-020-68640-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7366682PMC
July 2020

Prediction of Cardiovascular Disease Mortality in a Middle Eastern Country: Performance of the Globorisk and Score Functions in Four Population-Based Cohort Studies of Iran.

Int J Health Policy Manag 2020 Jul 15. Epub 2020 Jul 15.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Considering the importance of cardiovascular disease (CVD) risk prediction for healthcare systems and the limited information available in the Middle East, we evaluated the SCORE and Globorisk models to predict CVD death in a country of this region.

Methods: We included 24 427 participants (11 187 men) aged 40-80 years from four population-based cohorts in Iran. Updating approaches were used to recalibrate the baseline survival and the overall effect of the predictors of the models. We assessed the models' discrimination using C-index and then compared the observed with the predicted risk of death using calibration plots. The sensitivity and specificity of the models were estimated at the risk thresholds of 3%, 5%, 7%, and 10%. An agreement between models was assessed using the intra-class correlation coefficient (ICC). We applied decision analysis to provide perception into the consequences of using the models in general practice; for this reason, the clinical usefulness of the models was assessed using the net benefit (NB) and decision curve analysis. The NB is a sensitivity penalized by a weighted false positive (FP) rate in population level.

Results: After 154 522 person-years of follow-up, 437 cardiovascular deaths (280 men) occurred. The 10-year observed risks were 4.2% (95% CI: 3.7%-4.8%) in men and 2.1% (1.8-2%.5%) in women. The c-index for SCORE function was 0.784 (0.756-0.812) in men and 0.780 (0.744-0.815) in women. Corresponding values for Globorisk were 0.793 (0.766- 0.820) and 0.793 (0.757-0.829). The deviation of the calibration slopes from one reflected a need for recalibration; after which, the predicted-to-observed ratio for both models was 1.02 in men and 0.95 in women. Models showed good agreement (ICC 0.93 in men, and 0.89 in women). Decision curve showed that using both models results in the same clinical usefulness at the risk threshold of 5%, in both men and women; however, at the risk threshold of 10%, Globorisk had better clinical usefulness in women (Difference: 8%, 95% CI: 4%-13%).

Conclusion: Original Globorisk and SCORE models overestimate the CVD risk in Iranian populations resulting in a high number of people who need intervention. Recalibration could adopt these models to precisely predict CVD mortality. Globorisk showed better performance clinically, only among high-risk women.
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http://dx.doi.org/10.34172/ijhpm.2020.103DOI Listing
July 2020

External validation of the European risk assessment tool for chronic cardio-metabolic disorders in a Middle Eastern population.

J Transl Med 2020 07 2;18(1):267. Epub 2020 Jul 2.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: High burden of chronic cardio-metabolic disorders including type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD), and cardiovascular disease (CVD) have been reported in the Middle East and North Africa region. We aimed to externally validate a non-laboratory risk assessment tool for the prediction of the chronic cardio-metabolic disorders in the Iranian population.

Methods: The predictors included age, body mass index, waist circumference, use of antihypertensive medications, current smoking, and family history of cardiovascular disease and/or diabetes. For external validation of the model in the Tehran lipids and glucose study (TLGS), the Area under the curve (AUC) and the Hosmer-Lemeshow (HL) goodness of fit test were performed for discrimination and calibration, respectively.

Results: Among 1310 men and 1960 women aged 28-85 years, 29.5% and 47.4% experienced chronic cardio-metabolic disorders during the 6 and 9-year follow-up, respectively. The model showed acceptable discrimination, with an AUC of 0.72 (95% CI 0.69-0.75) for men and 0.73 (95% CI 0.71-0.76) for women. The calibration of the model was good for both genders (min HL P = 0.5). Considering separate outcomes, AUC was highest for CKD (0.76 (95% CI 0.72-0.79)) and lowest for T2DM (0.65 (95% CI 0.61-0.69)), in men. As for women, AUC was highest for CVD (0.82 (95% CI 0.78-0.86)) and lowest for T2DM (0.69 (95% CI 0.66-0.73)). The 9-year follow-up demonstrated almost similar performances compared to the 6-year follow-up. Using Cox regression in place of logistic multivariable analysis, model's discrimination and calibration were reduced for prediction of chronic cardio-metabolic disorders; the issue which had more effect on the prediction of incident CKD among women. Moreover, adding data of educational levels and marital status did not improve, the discrimination and calibration in the enhanced model.

Conclusion: This model showed acceptable discrimination and good calibration for risk prediction of chronic cardio-metabolic disorders in short and long-term follow-up in the Iranian population.
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http://dx.doi.org/10.1186/s12967-020-02434-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331242PMC
July 2020

The external validity and performance of the no-laboratory American Diabetes Association screening tool for identifying undiagnosed type 2 diabetes among the Iranian population.

Prim Care Diabetes 2020 12 7;14(6):672-677. Epub 2020 Jun 7.

Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Department of Biostatistics and Epidemiology, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address:

Aims: The aim of this study is to assess the American Diabetes Association (ADA) risk score as a self-assessment screening tool for undiagnosed type 2 diabetes (T2DM) in Iran.

Methods: In a national survey of risk factors for non-communicable diseases, we included 3458 Iranian adults. The discrimination and validity were assessed using the area under the curve (AUC), sensitivity, specificity, Youden's index, positive and negative predictive values (PPV and NPV). The frequency of high-risk Iranian population who need a glucose test and those who need intervention were also estimated.

Results: The AUC was 73.7% and the suggested ADA score of ≥5 yielded a sensitivity of 51.6%, specificity 82.4%, NPV 98.3%, and PPV 7.9%. This threshold results in classifying 18.6% of the Iranians, equals to 8.5 million, as high-risk and 1.5% of the population, about 700,000, would need intervention. However, our study suggested score ≥4 that identified 34% of the population as high-risk and 2% of the population would need intervention.

Conclusion: Our findings support the ADA suggested threshold for identifying high-risk individuals for undiagnosed T2DM; however, a lower threshold is also recommended for higher sensitivity. The ADA screening tool could help the public health system for low-cost screening.
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http://dx.doi.org/10.1016/j.pcd.2020.04.001DOI Listing
December 2020

Sex-Specific Incidence Rates and Risk Factors for Hypertension During 13 Years of Follow-up: The Tehran Lipid and Glucose Study.

Glob Heart 2020 04 8;15(1):29. Epub 2020 Apr 8.

Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, IR.

Background: Hypertension, with a prevalence of 25.6% is a serious public health concern in Iran.

Objective: To investigate the population-based incidence of hypertension and its potential risk factors in Tehranian adults during a median follow-up of 13.1 years.

Methods: A total of 6,533 non-hypertensive participants (women = 3,639), aged ≥20 years participated in the study. Crude and age-standardized incidence rates per 1000 person-years were calculated for each sex, separately. Multivariable Cox proportional hazard models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for all potential risk factors.

Results: The crude and age-standardized incidence rates (95% CI) of hypertension per 1000 person-years were 29.7 (27.8-31.6) and 34.9 (32.5-37.4) among men and 25.8 (24.3-27.3) and 38.7 (35.5-42.0) among women, respectively. The incidence rate of hypertension in younger age groups was higher among men. However, after the 4 decade, the incidence rate was higher among women. Significant interactions of sex with age groups, body mass index categories, marital status, hypertriglyceridemia and glycemic categories were found in multivariable analyses (all p-values < 0.05). In the multivariable model, the risk in both sexes was found to be significantly associated with older age, obesity, and normal or high normal blood pressure (BP). Moreover, factors such as being overweight [HR: 1.20 (1.00-1.44)], former smoking [2.15 (1.52-3.04)], hypertriglyceridemia [1.23 (1.06-1.43)] and pre-diabetes status [1.19 (1.02-1.39)] were significant predictors of incident hypertension among women. Central obesity was found to be a significant predictor among men [1.26 (1.03-1.54)]. The optimism-corrected Harrell's C index (95% CI) in the categorical adjusted model was 0.75 (0.74-0.79) among men and 0.75 (0.74-0.76) among women.

Conclusion: In the Tehranian population, nearly 2.7% of total participants (3% of men and 2.6% of women) develop hypertension each year. Obesity and high BP levels are the main modifiable risk factors in both sexes. Hypertriglyceridemia, prediabetes and former smoking are risk factors for hypertension among women.
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http://dx.doi.org/10.5334/gh.780DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218790PMC
April 2020

Is there any association between age at menarche and anthropometric indices? A 15-year follow-up population-based cohort study.

Eur J Pediatr 2020 Sep 7;179(9):1379-1388. Epub 2020 Mar 7.

Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Anthropometric indices (AI) have been known to be associated with age at menarche (AAM). The aim of this longitudinal study was to evaluate the changes in AI and its association with AAM in a community-based population in Iran. From among 10,192 women, we included 6818, aged ≥ 10 years, who were post-menarche at the time of entering the study and their AAM ranged between 8 and 18 years. Study subjects were divided into groups by tertiles birth cohort (BC) (born ≤ 1939, 1940-1969, and ≥ 1970) and AAM (≤ 11, 12-15, and ≥ 16 years). Generalized estimating equation analysis was performed to evaluate the association between changes of AI in different BCs with AAM groups. Overall mean of AAM was 13.5 ± 1.4 years. Mean body mass index (BMI) was significantly increased over time more in those with early AAM (≤ 11 years) compared to those with AAM ≥ 16 years; changes in mean BMI of 1.24 kg/m (95% CI 0.32, 2.15), 2.61 kg/m (95% CI 1.90, 3.33), and 3.99 kg/m (95% CI 2.46, 5.51) in BC ≥ 1970, BC (1940-1969), and, BC ≤ 1939, respectively.Conclusion: Our findings showed an inverse association of AAM with mean BMI, waist to height ratio, and waist circumference, an association weaker in younger women compared to other age groups. What is Known: • Limited data are available on the association of menarcheal age with anthropometric indices. • Previous studies reported conflicting and inclusive results of this association. What is New: • Our results can provide beneficial information on the association of menarcheal age with anthropometric indices based on different age groups. • This long follow-up study shows an association of menarcheal age with anthropometric indices which are stronger in older women except for height.
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http://dx.doi.org/10.1007/s00431-020-03575-xDOI Listing
September 2020

Association of lipid markers with coronary heart disease and stroke mortality: A 15-year follow-up study.

Iran J Basic Med Sci 2019 Nov;22(11):1325-1330

Department of Community Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objectives: It has been proposed that lipid markers may predict cardiovascular events; however, their effect may vary depending on the type of cardiovascular disease. The purpose of this study was to investigate the effects of lipid markers on death from coronary heart disease (CHD) and stroke in competing risks setting.

Materials And Methods: Participants included 2502 women and 2020 men, age 40 years or older from Tehran Lipid and Glucose Study. The association between total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C) with hazard and cumulative incidence of CHD and stroke was investigated using cause-specific hazard and sub-distribution hazard models. Statistical analyses were performed using "risk regression" and "cmprsk" package in R 3.3.2.

Results: One standard deviation (SD) increase in TC and LDL-C increased the hazard of CHD death by 1.42 (CI=1.07,1.89) and 1.41 (CI=1.04,1.93), respectively. 1-SD increase in TG increased the cumulative incidence of CHD death increased by 1.94 (CI=1.02,3.75) in women. Other risk factors were not associated with the hazard and cumulative incidence of CHD in women, men and the total sample. In addition, none of lipids had a significant effect on the hazard and cumulative incidence of stroke in men, women and the total sample.

Conclusion: The associations of lipid components on CHD death were modified by gender. TC, LDL-C and TG were independent predictors of CHD mortality in women. Furthermore, death due to stroke changes the association of lipid markers with CHD mortality.
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http://dx.doi.org/10.22038/ijbms.2019.35617.8775DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7038418PMC
November 2019

A comparison of the effects of oral contraceptives on the clinical and biochemical manifestations of polycystic ovary syndrome: a crossover randomized controlled trial.

Hum Reprod 2020 01;35(1):175-186

Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Study Question: Do oral contraceptives (OCs) containing progestins with low androgenic or antiandrogenic activities have different effects to those containing levonorgestrel (LNG) on clinical, androgenic and metabolic manifestations of polycystic ovarian syndrome (PCOS)?

Summary Answer: The three OCs tested had similar effects on clinical findings of hyperandrogenism (HA), whereas products containing LNG were less effective on androgenic profiles and had detrimental effects on lipid profiles.

What Is Known Already: Despite data available on the effects of OCs, the superiority of products with low androgenic or antiandrogenic progesterone components in comparison with older products used in women with PCOS has not been clarified.

Study Design, Size, Duration: This study is a crossover randomized controlled six-arm trial, with all six arms including two 6-month treatment periods, one period with OCs containing LNG, and the other with one of three OCs containing desogestrel (DSG), cyproterone acetate (CPA) or drospirenone (DRSP). The trial was conducted between February 2016 and January 2018 and enrolled 200 patients with PCOS.

Participants/materials, Setting, Methods: Two hundred women with PCOS (ages 18-45 years) were recruited at the endocrine outpatient clinic of the Research Institute for Endocrine Sciences (RIES) of the Shahid Beheshti University of Medical Sciences, Tehran, Iran. A blocking or stratification random allocation (block size = 6) using a computer-based random number generator was prepared to assign participants to treatment groups. Both the clinical examiner and data analyst were blinded to participants during the trial. Outcomes of interest, including anthropometric and clinical manifestations and hormonal, and biochemical parameters were assessed at baseline, after 3 and 6 months of each treatment and after the washout period.

Main Results And The Role Of Chance: This study detected a higher decrease in free-androgen index (FAI) levels after 3 months of treatment with OCs containing DSG (95% CI: -2.3, -1.0), CPA (95% CI: -2.4, -1.1) and DRSP (95% CI: -2.6, -1.4), compared with products containing LNG (P < 0.001). Use of OCs containing DSG (95% CI: -3.6, -1.5), CPA (95% CI: -3.1, -0.8) and DRSP (95% CI: -3.4, -1.1) for 6 months was associated with more decrease in FAI, compared with products containing LNG (P < 0.001). The study showed that use of OCs containing DSG, CPA and DRSP for 3-6 months was associated with a higher increase of sex hormone-binding globulin (SHBG), compared with products containing LNG (P < 0.001). We also observed more decrease in dehydroepiandrosterone sulfate levels after use of OCs containing DSG (P = 0.003), CPA (P = 0.012) and DRSP (P < 0.001) for 6 months, compared with products containing LNG. Our results showed that the use of OCs containing DRSP for 6 months was associated with more improvement in acne, compared with products containing LNG (P = 0.007). Women treated with OCs containing CPA, and DRSP for 3 months had higher TG and HDL levels and lower LDL levels, compared with those treated with products containing LNG (P < 0.05). After 6 months of treatment, patients treated with OCs containing DRSP had a sharper decline in LDL levels and more increase in HDL levels, compared to those treated with products containing LNG (P = 0.001).

Limitations, Reasons For Caution: Considering this trial was conducted in women diagnosed with Androgen Excess Society criteria, the results may not be generalizable for mild phenotypes diagnosed using Rotterdam criteria. Other limitations of the study include the high dropout rate, the lack of a gold standard androgen assay and the multiple end points.

Wider Implications Of The Findings: Our results support the views of clinicians, who suggest an OC with a low androgenic or antiandrogenic progestin, if available, to treat PCOS.

Study Funding/competing Interest(s): This study was supported by the RIES, Shahid Beheshti University of Medical Sciences, Tehran, Iran. There are no conflicts of interest.

Trial Registration Number: IRCT201702071281N2.

Trial Registration Date: 21 February 2017.

Date Of First Patient’s Enrolment: 21 March 2017.
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http://dx.doi.org/10.1093/humrep/dez255DOI Listing
January 2020