Publications by authors named "Tali Cukierman-Yaffe"

46 Publications

Quality of life of patients with thyroid eye disease: 3-year follow-up in a multidisciplinary clinic in Israel.

Graefes Arch Clin Exp Ophthalmol 2021 Feb 2. Epub 2021 Feb 2.

Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel.

Background: Changes in the quality of life (QOL) of patients with thyroid eye disease (TED) were examined during a 3-year follow-up in a multidisciplinary eye clinic, and factors that may improve QOL were identified.

Methods: A retrospective review of medical records of all patients who attended the TED clinic at Sheba Medical Center, Israel, from May 2016 to May 2019 was performed. The retrieved data included demographics, comprehensive ophthalmic examination findings, clinical activity scores (CAS), laboratory test results, and QOL assessments by the Graves' Orbitopathy QOL (GO-QOL) questionnaire.

Results: One hundred thirty-two TED clinic patients were examined. Thirty patients (22.72%) received medical treatment consisting of steroids according to the European Group on Graves' Orbitopathy (EUGOGO) protocol, high-dose steroids, or immunosuppressive drugs. Twenty-eight patients (21.21%) underwent surgical rehabilitation (decompression, strabismus, or eyelid surgery). There was a significant increase in total QOL score after steroid treatment according to the EUGOGO protocol, after decompression surgery, and after strabismus surgery compared to pre-treatment total QOL (p=0.04, p=0.021, and p=0.042, respectively, matched pairs). In addition, there were significant positive correlations between the changes in the total QOL score and the change in thyroid-stimulating immunoglobulin (TSI) as well as the change in CAS among the patients who underwent medical and surgical interventions.

Conclusions: QOL improved significantly after medical/surgical treatments. A change in the CAS and in the TSI may also correlate with change in QOL. Periodic evaluation of TED patients' QOL is recommended for enhanced and more comprehensive management.
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http://dx.doi.org/10.1007/s00417-021-05103-5DOI Listing
February 2021

The Relationship Between Glucose Control and Cognitive Function in People With Diabetes After a Lacunar Stroke.

J Clin Endocrinol Metab 2021 Mar;106(4):e1521-e1528

Department of Medicine, Division of Neurology, University of British Columbia, Vancouver, British Columbia, Canada.

Context: Lacunar strokes and diabetes are risk factors for cognitive dysfunction. Elucidating modifiable risk factors for cognitive dysfunction has great public health implications. One factor may be glycemic status, as measured by glycated hemoglobin (A1c).

Objective: The aim of this study was to assess the relationship between A1c and cognitive function in lacunar stroke patients with diabetes.

Methods: The effect of baseline and follow-up A1c on the baseline and the change in Cognitive Assessment Screening Instrument (CASI) score over time among participants with a median of 2 cognitive assessments (range, 1-5) was examined in 942 individuals with diabetes and a lacunar stroke who participated in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial (ClinicalTrials.gov No. NCT00059306).

Results: Every 1% higher baseline A1c was associated with a 0.06 lower standardized CASI z score (95% CI, -0.101 to -0.018). Higher baseline A1c values were associated with lower CASI z scores over time (P for interaction = .037). A 1% increase in A1c over time corresponded with a CASI score decrease of 0.021 (95% CI, -0.0043 to -0.038) during follow-up. All these remained statistically significant after adjustment for age, sex, education, race, depression, hypertension, hyperlipidemia, body mass index, cardiovascular disease, obstructive sleep apnea, diabetic retinopathy, nephropathy insulin use, and white-matter abnormalities.

Conclusion: This analysis of lacunar stroke patients with diabetes demonstrates a relationship between A1c and change in cognitive scores over time. Intervention studies are needed to delineate whether better glucose control could slow the rate of cognitive decline in this high-risk population.
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http://dx.doi.org/10.1210/clinem/dgab022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993572PMC
March 2021

Stuttering and Incident Type 2 Diabetes: A Population-Based Study of 2.2 Million Adolescents.

J Clin Endocrinol Metab 2021 Mar;106(4):978-987

The Israel Defense Forces Medical Corps, Ramat Gan, Israel.

Purpose: To investigate the association between stuttering in adolescence and incident type 2 diabetes in young adulthood.

Methods: This nationwide population-based study included 2 193 855 adolescents of age 16 to 20 years who were assessed for military service between 1980 and 2013. Diagnoses of stuttering in adolescence were confirmed by a speech-language pathologist. Diabetes status for each individual as of December 31, 2016, was determined by linkage to the Israeli National Diabetes Registry. Relationships were analyzed using regression models adjusted for socioeconomic variables, cognitive performance, coexisting morbidities, and adolescent body mass index.

Results: Analysis was stratified by sex (Pinteraction = 0.035). Of the 4443 (0.4%) adolescent men with stuttering, 162 (3.7%) developed type 2 diabetes, compared with 25 678 (2.1%) men without stuttering (adjusted odds ratio [OR] 1.3; 95% CI, 1.1-1.6). This relationship persisted when unaffected brothers of men with stuttering were used as the reference group (adjusted OR = 1.5; 95% CI, 1.01-2.2), or when the analysis included only adolescents with unimpaired health at baseline (adjusted OR = 1.4; 95% CI, 1.1-1.7). The association was stronger in later birth cohorts, with an adjusted OR of 2.4 (1.4-4.1) for cases of type 2 diabetes before age 40. Of the 503 (0.1%) adolescent women with stuttering 7 (1.4%) developed type 2 diabetes, compared with 10 139 (1.1%) women without stuttering (OR = 2.03; 95% CI, 0.48-2.20).

Conclusions: Adolescent stuttering is associated with an increased risk for early-onset type 2 diabetes among men.
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http://dx.doi.org/10.1210/clinem/dgaa988DOI Listing
March 2021

Sensorimotor and Cognitive Abilities Associated With Touchscreen Tablet App Performance to Support Self-Management of Type 2 Diabetes.

Am J Occup Ther 2021 Jan-Feb;75(1):7501205080p1-7501205080p9

Debbie Rand, OT, PhD, is Senior Lecturer, Department of Occupational Therapy, Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel;

Importance: Self-management programs (facilitated by mobile devices) may improve health and prevent secondary complications for older adults with diabetes. However, older adults may have difficulties using mobile devices because of neuropathy or cognitive dysfunction.

Objective: To identify sensorimotor and cognitive abilities associated with touchscreen tablet app performance to support self-management of diabetes in older adults.

Design: Cross-sectional study.

Setting: Outpatient Center for Successful Aging With Diabetes.

Participants: Forty-five older adults with Type 2 diabetes.

Outcomes And Measures: Dexterity (Purdue Pegboard Test), touch sensation (Semmes-Weinstein monofilaments), pinch strength (pinch gauge), cognition (Montreal Cognitive Assessment), and executive functioning (Trail Making Test) were assessed. Two apps were then used: Dexteria and SuCare. Demographic data, prior mobile device use, and diabetes severity (hemoglobin A1C [HbA1C]) were collected.

Results: Age and HbA1C accounted for 29.8% and 9.7%, respectively, of the total variance of Dexteria performance time (dominant hand). Dexterity (dominant hand) accounted for an additional 5.4% of the total variance of 45.1%, F(4, 40) = 10.021, p < .001. Prior mobile device use, age, and diabetes severity accounted for 6.4%, 11.8%, and 26.4%, respectively, of the total variance of SuCare performance time. Executive functioning and dominant-hand dexterity accounted for an additional 9.5% and 9.4%, respectively, of the total variance of 61.0%, F(5, 39) = 14.75, p < .001.

Conclusions And Relevance: Beyond age and diabetes severity, executive functioning and dominant-hand dexterity contributed to app performance, highlighting the importance of diabetes self-management. These findings may help determine suitable candidates for tablet use for self-management.

What This Article Adds: App performance is explained by the executive functioning and dexterity of older adults with Type 2 diabetes. These factors, in addition to age and diabetes severity, should be taken into consideration by occupational therapy practitioners in future mobile self-management programs.
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http://dx.doi.org/10.5014/ajot.2021.040600DOI Listing
January 2021

Gender differences in clinical presentation and prognosis of thyroid eye disease.

Eur J Ophthalmol 2020 Nov 6:1120672120964112. Epub 2020 Nov 6.

Goldschleger Eye Institute, Sheba Medical Center, Tel-Hashomer, Israel.

Objective: To examine the clinical differences in manifestation, treatment, and prognosis of thyroid-eye-disease (TED) between men and women.

Methods: This is a longitudinal cohort study. Men and women, who diagnosed with TED and treated at a multidisciplinary TED clinic, were compared regarding differences in demographics, eye examination, disease activity, and quality of life evaluation.

Results: TED was diagnosed in 132 patients during the study period, and they included 38 men (28.78%) and 94 women (71.21%). There were six men and 20 women with active disease (Clinical-Activity-Score (CAS) ⩾ 3) during the entire follow-up period ( < 0.01). The mean time from TED diagnosis to CAS ⩾ 3 was 4.50 years for men and 2.35 years for women ( = 0.05). There were no significant differences in mean total Graves' Orbitopathy-Quality-of-Life questionnaire (GO-QOL) score. However, mean GO-QOL subtotal score of external appearance of women was significantly lower compare to men in the first and last visit ( = 0.04, 0.03, respectively).

Conclusion: Active disease was more common in women and the time-from-diagnosis of TED to CAS ⩾ 3 was shorter among women. Moreover, the appearance QOL score of women was poorer. These findings should be taken into consideration when planning the timing of treatment and when choosing the best treatment for TED patients.
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http://dx.doi.org/10.1177/1120672120964112DOI Listing
November 2020

Adolescent Nonalcoholic Fatty Liver Disease and Type 2 Diabetes in Young Adulthood.

J Clin Endocrinol Metab 2021 Jan;106(1):e34-e44

Department of Military Medicine, Hebrew University, Jerusalem and the Israel Defense Forces Medical Corps, Ramat Gan, Israel.

Context: The long-term risk of type 2 diabetes in adolescents with nonalcoholic fatty liver disease (NAFLD) is unclear.

Objective: To assess type 2 diabetes risk among adolescents with NAFLD.

Design And Setting: A nationwide, population-based study of Israeli adolescents who were examined before military service during 1997-2011 and were followed until December 31, 2016.

Participants: A total of 1 025 796 normoglycemic adolescents were included.

Interventions: Biopsy or radiographic tests were prerequisite for NAFLD diagnosis. Data were linked to the Israeli National Diabetes Registry.

Main Outcome Measures: Type 2 diabetes incidence.

Results: During a mean follow-up of 13.3 years, 12 of 633 adolescents with NAFLD (1.9%; all with high body mass index [BMI] at baseline) were diagnosed with type 2 diabetes compared with 2917 (0.3%) adolescents without NAFLD. The hazard ratio (HR) for type 2 diabetes was 2.59 (95% confidence interval [CI], 1.47-4.58) for the NAFLD vs. the non-NAFLD group after adjustment for BMI and sociodemographic confounders. The elevated risk persisted in several sensitivity analyses. These included an analysis of persons without other metabolic comorbidities (adjusted HR, 2.75 [95% CI, 1.48-5.14]) and of persons with high BMI; and an analysis whose outcome was type 2 diabetes by age 30 years (adjusted HR, 2.14 [95% CI, 1.02-4.52]). The results remained significant when a sex-, birth year-, and BMI-matched control group was the reference (adjusted HR, 2.98 [95% CI, 1.54-5.74]).

Conclusions: Among normoglycemic adolescents, NAFLD was associated with an increased adjusted risk for type 2 diabetes, which may be apparent before age 30 years.
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http://dx.doi.org/10.1210/clinem/dgaa753DOI Listing
January 2021

Adolescent BMI and early-onset type 2 diabetes among Ethiopian immigrants and their descendants: a nationwide study.

Cardiovasc Diabetol 2020 10 6;19(1):168. Epub 2020 Oct 6.

Department of Military Medicine, Hebrew University, Jerusalem and the Israel Defense Forces Medical Corps, Ramat Gan, Israel.

Background: We assessed in a nationwide cohort the association between adolescent BMI and early-onset (< 40 years) type 2 diabetes among Israelis of Ethiopian origin.

Methods: Normoglycemic adolescents (range 16-20 years old), including 93,806 native Israelis (≥ 3rd generation in Israel) and 27,684 Israelis of Ethiopian origin, were medically assessed for military service between 1996 and 2011. Weight and height were measured. Data were linked to the Israeli National Diabetes Registry. Incident type 2 diabetes by December 31, 2016 was the outcome. Cox regression models stratified by sex and BMI categories were applied.

Results: 226 (0.29%) men and 79 (0.18%) women developed diabetes during 992,980 and 530,814 person-years follow-up, respectively, at a mean age of 30.4 and 27.4 years, respectively. Among native Israeli men with normal and high (overweight and obese) BMI, diabetes incidence was 9.5 and 62.0 (per 10 person-years), respectively. The respective incidences were 46.9 and 112.3 among men of Ethiopian origin. After adjustment for sociodemographic confounders, the hazard ratios for type 2 diabetes among Ethiopian men with normal and high BMI were 3.4 (2.3-5.1) and 15.8 (8.3-30.3) respectively, compared to third-generation Israelis with normal BMI. When this analysis was limited to Israeli-born Ethiopian men, the hazard ratios were 4.4 (1.7-11.4) and 29.1 (12.9-70.6), respectively. Results persisted when immigrants of other white Caucasian origin were the reference; and among women with normal, but not high, BMI.

Conclusions: Ethiopian origin is a risk factor for early-onset type 2 diabetes among young men at any BMI, and may require selective interventions.
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http://dx.doi.org/10.1186/s12933-020-01143-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542395PMC
October 2020

Diabetes in ageing: pathways for developing the evidence base for clinical guidance.

Lancet Diabetes Endocrinol 2020 10;8(10):855-867

King's College London, London, UK; Diabetes Frail, London, UK.

Older adults with diabetes are heterogeneous in their medical, functional, and cognitive status, and require careful individualisation of their treatment regimens. However, in the absence of detailed information from clinical trials involving older people with varying characteristics, there is little evidence-based guidance, which is a notable limitation of current approaches to care. It is important to recognise that older people with diabetes might vary in their profiles according to age category, functional health, presence of frailty, and comorbidity profiles. In addition, all older adults with diabetes require an individualised approach to care, ranging from robust individuals to those residing in care homes with a short life expectancy, those requiring palliative care, or those requiring end-of-life management. In this Review, our multidisciplinary team of experts describes the current evidence in several important areas in geriatric diabetes, and outlines key research gaps and research questions in each of these areas with the aim to develop evidence-based recommendations to improve the outcomes of interest in older adults.
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http://dx.doi.org/10.1016/S2213-8587(20)30230-8DOI Listing
October 2020

A Comprehensive Intervention for Promoting Successful Aging Amongst Older People With Diabetes With Below-Normal Cognitive Function-A Feasibility Study.

Front Endocrinol (Lausanne) 2020 2;11:348. Epub 2020 Jun 2.

Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.

Older people with diabetes have an increased risk for disability and cognitive dysfunction, which may impede self-care capacity. These are not evaluated routinely in current health systems. In the Center for Successful Aging with Diabetes, patients over the age of 60 undergo multi-disciplinary evaluation days and are provided with an integrated (cognitive, physical, nutritional, and medical) treatment plan. Among individuals with below-normal cognitive function, self-adherence to these recommendations poses a challenge. Thus, the aim of this study was to test the feasibility of a multidisciplinary intervention amongst older people with diabetes with below-normal cognitive function and sub-optimal glucose control. Patients with a MoCA score under 26 and A1C >= 7.5% participated in a two-arm intervention: (A) a medical intervention: monthly meetings with a diabetes nurse-educator, supervised by a diabetes specialist and study psychologist during which changes in their pharmacological regimen of glucose, blood pressure, and lipid control were made and (B) a cognitive/physical rehabilitation intervention. This arm consisted of (1) an intensive phase-group meetings which included computerized cognitive training, aerobic, balance, and strength exercise, and group discussions and (2) a monthly consolidation phase. Outcomes included change in A1C, change in strength, balance, and aerobic exercise capacity as well as change in quality of life. After 12 months there was a 0.7% reduction in A1C. After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go). There was no additional improvement in physical indices between the 3 and 12 month visits. For some of the physical measures, the improvement observed after 3 months persisted partially to the 12-month visit. This feasibility study provides preliminary data that support the efficacy of the complex interventions described. The findings suggest that this older population would require an ongoing "intensive phase" intervention. Larger prospective randomized trials are needed.
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http://dx.doi.org/10.3389/fendo.2020.00348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7326129PMC
June 2020

Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.

Lancet Neurol 2020 07;19(7):582-590

Robert Koch Medical Center, Sofia, Bulgaria.

Background: Diabetes is an independent risk factor for cognitive impairment. We aimed to investigate the association between the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide and cognitive impairment as an exploratory analysis within the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial.

Methods: REWIND is a randomised, double-blind placebo-controlled trial at 371 sites in 24 countries. We included men and women (aged ≥50 years) with either established or newly diagnosed type 2 diabetes and additional cardiovascular risk factors, glycated haemoglobin of up to 9·5% (80 mmol/mol) on a maximum of two oral glucose-lowering drugs with or without basal insulin, and a body-mass index of at least 23 kg/m. Participants were randomly assigned (1:1) subcutaneous injections once a week of either dulaglutide (1·5 mg) or an equal volume of matching placebo. Randomisation was done using a computer-generated code with stratification by site. Participants and all study personnel were masked to treatment allocation until the database was locked. Participants were followed up at least every 6 months for the composite primary outcome of stroke, myocardial infarction, or death from cardiovascular or unknown causes. Cognitive function was assessed at baseline and during follow-up using the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). We present here the exploratory primary cognitive outcome, which was the first occurrence of a follow-up score on MoCA or DSST that was 1·5 SDs or more below the baseline mean score in the participant's country. All analyses were done using an intention-to-treat approach. The REWIND trial is registered with ClinicalTrials.gov, NCT01394952.

Findings: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were randomly assigned to either dulaglutide (n=4949) or placebo (n=4952). During median follow-up of 5·4 (IQR 5·1-5·9) years, 8828 participants provided a baseline and one or more follow-up MoCA or DSST scores, of whom 4456 were assigned dulaglutide and 4372 were assigned placebo. The cognitive outcome occurred in 4·05 per 100 patient-years in participants assigned dulaglutide and 4·35 per 100 patient-years in people assigned placebo (hazard ratio [HR] 0·93, 95% CI 0·85-1·02; p=0·11). After post-hoc adjustment for individual standardised baseline scores, the hazard of substantive cognitive impairment was reduced by 14% in those assigned dulaglutide (HR 0·86, 95% CI 0·79-0·95; p=0·0018).

Interpretation: Long-term treatment with dulaglutide might reduce cognitive impairment in people with type 2 diabetes. Further studies of this drug focused on brain health and cognitive function are clearly indicated.

Funding: Eli Lilly and Company.
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http://dx.doi.org/10.1016/S1474-4422(20)30173-3DOI Listing
July 2020

Determining the Optimal Cognitive Screening Tool in Older People With Diabetes.

Front Endocrinol (Lausanne) 2020 22;11:322. Epub 2020 May 22.

The Center for Successful Aging With Diabetes, Sheba Medical Center, Endocrinology Institute, Rama Gan, Israel.

Self-care is an important perspective to aging and transitional states in diabetes management. Population studies have shown that lower cognitive function is associated with worse self-care abilities. Several guidelines have emphasized the importance of assessing cognitive function in older people with diabetes and tailoring treatment plan accordingly. Those guidelines do not specify which tools are the most appropriate for this population. One approach to delineate which tools should be used is to assess which tools best correlate with self-care capacity. To assess which cognitive assessment tools best correlate with self-care capacity in older people with type 2 diabetes. Cross-sectional study, conducted amongst individuals with diabetes over the age of 60. The association between self-care capacity indices and different cognitive assessment tools was examined. Principal Component self-care constructs were determined and the association between these and the different cognitive assessment tools was examined. A significant association was found between the Principal Component self-care construct and the Montreal Cognitive Assessment and Mindstreams scores. In a stepwise regression model including only the Montreal Cognitive Assessment score, a significant association was found between this score and the Principal Component self-care construct. The same was not found in a model that included only the Mindstreams scores. The Montreal Cognitive Assessment, previously validated as a brief cognitive screening tool, may be useful as an adjunct to assess the self-care capacity of older individuals with diabetes. Future studies in the clinic are needed to evaluate if using this tool may improve treatment plans.
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http://dx.doi.org/10.3389/fendo.2020.00322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7258911PMC
May 2020

Adolescent Obesity and Early-Onset Type 2 Diabetes.

Diabetes Care 2020 07 22;43(7):1487-1495. Epub 2020 Apr 22.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Objective: Type 2 diabetes (T2D) is increasingly diagnosed at younger ages. We investigated the association of adolescent obesity with incident T2D at early adulthood.

Research Design And Methods: A nationwide, population-based study evaluated 1,462,362 adolescents (59% men, mean age 17.4 years) during 1996-2016. Data were linked to the Israeli National Diabetes Registry. Weight and height were measured at study entry. Cox proportional models were applied.

Results: During 15,810,751 person-years, 2,177 people (69% men) developed T2D (mean age at diagnosis 27 years). There was an interaction among BMI, sex, and incident T2D ( = 0.023). In a model adjusted for sociodemographic variables, the hazard ratios for diabetes diagnosis were 1.7 (95% CI 1.4-2.0), 2.8 (2.3-3.5), 5.8 (4.9-6.9), 13.4 (11.5-15.7), and 25.8 (21.0-31.6) among men in the 50th-74th percentile, 75th-84th percentile, overweight, mild obesity, and severe obesity groups, respectively, and 2.2 (1.6-2.9), 3.4 (2.5-4.6), 10.6 (8.3-13.6), 21.1 (16.0-27.8), and 44.7 (32.4-61.5), respectively, in women. An inverse graded relationship was observed between baseline BMI and mean age of T2D diagnosis: 27.8 and 25.9 years among men and women with severe obesity, respectively, and 29.5 and 28.5 years among low-normal BMI (5th-49th percentile; reference), respectively. The projected fractions of adult-onset T2D that were attributed to high BMI (≥85th percentile) at adolescence were 56.9% (53.8-59.9%) and 61.1% (56.8-65.2%) in men and women, respectively.

Conclusions: Severe obesity significantly increases the risk for incidence of T2D in early adulthood in both sexes. The rise in adolescent severe obesity is likely to increase diabetes incidence in young adults in coming decades.
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http://dx.doi.org/10.2337/dc19-1988DOI Listing
July 2020

Very restricted carbohydrate (ketogenic) diet: A rare cause of a recurrent hypoglycemic-euglycemic diabetic ketoacidosis in the pregnancy.

Eur J Obstet Gynecol Reprod Biol 2020 05 7;248:257-258. Epub 2020 Mar 7.

Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Israel.

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http://dx.doi.org/10.1016/j.ejogrb.2020.03.021DOI Listing
May 2020

Towards Implementation of the Saint Vincent Declaration: Outcomes of Women with Pregestational Diabetes.

Isr Med Assoc J 2020 Mar;22(3):137-141

Department of Endocrinology, Sheba Medical Center, Tel Hashomer, Israel.

Background: Pregestational diabetes mellitus (PGDM) carries a significantly elevated risk of adverse maternal and fetal outcomes. There is evidence that certain interventions reduce the risk for adverse outcomes. Studies have shown that a multi-disciplinary approach improves pregnancy outcomes in women with PGDM.

Objectives: To determine pregnancy outcomes in women with PGDM using a multi-disciplinary approach.

Methods: We retrospectively reviewed consecutive women with pregestational type 1 and type 2 diabetes who were monitored at a high-risk pregnancy clinic at the Sheba Medical Center. Clinical data were obtained from the medical records. All data related to maternal glucose control and insulin pump function were prospectively recorded on Medtronic CareLink® pro software (Medtronic MiniMed, Northridge, CA).

Results: This study comprised 121 neonates from 116 pregnancies of 94 women. In 83% of the pregnancies continuous glucose monitoring (CGM) sensors were applied during a part or all of the pregnancy. Pregnancy outcomes among women who were followed by a multi-disciplinary team before and during pregnancy, and during labor and puerperium resulted in better glucose control (hemoglobin A1c 6.4% vs. 7.8%), lower risk for pregnancy induced hypertension/preeclampsia (7.7% vs. 15.6%), lower birth weight (3212 g vs. 3684 g), and lower rate of large size for gestational age and macrosomia (23.1% vs. 54.2% and 3.3% vs. 28.4%, respectively), compared to data from European cohorts.

Conclusions: The multi-disciplinary approach for treating women with PGDM practiced in the high-risk pregnancy clinic at the Sheba Medical Center resulted in lower rates of macrosomia, LGA, and pregnancy induced hypertension compared to rates reported in the literature.
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March 2020

Are large simple trials for dementia prevention possible?

Age Ageing 2020 02;49(2):154-160

Population Health Research Institute, McMaster University & Hamilton Health Sciences, Canada.

New trials of dementia prevention are needed to test novel strategies and agents. Large, simple, cardiovascular trials have successfully discovered treatments with moderate but worthwhile effects to prevent heart attack and stroke. The design of these trials may hold lessons for the dementia prevention. Here we outline suitable populations, interventions and outcomes for large simple trials in dementia prevention. We consider what features are needed to maximise efficiency. Populations could be selected by age, clinical or genetic risk factors or clinical presentation. Patients and their families prioritise functional and clinical outcomes over cognitive scores and levels of biomarkers. Loss of particular functions or dementia diagnoses therefore are most meaningful to participants and potential patients and can be measured in large trials. The size of the population and duration of follow-up needed for dementia prevention trials will be a major challenge and will need collaboration between many clinical investigators, funders and patient organisations.
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http://dx.doi.org/10.1093/ageing/afz152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047819PMC
February 2020

The association between novel glucose indices in parturients with type 1 diabetes mellitus and clinically significant neonatal hypoglycemia.

Gynecol Endocrinol 2020 Jul 11;36(7):615-619. Epub 2019 Dec 11.

Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

The aim of this study was to determine the association between glucose control indices of parturient with type 1 diabetes (T1DM), treated with an insulin pump and utilizing continuous glucose monitoring (CGM), and clinically significant neonatal hypoglycemia. This was a retrospective cohort study which included 37 pregnant women with T1DM. All women were followed at a single tertiary center and had available CGM data. The association between maternal glucose indices before delivery and the risk for neonatal hypoglycemia requiring IV glucose (clinically significant hypoglycemia) was assessed using logistic regression. Mothers to neonates that experienced clinically significant hypoglycemia had a higher glucose standard deviation (SD) before delivery than did mothers to neonates who did not (25.5 ± 13 mg/dL vs. 14.7 ± 6.7 mg/dl respectively;  = .008). This association persisted after adjustment for maternal age, maternal pregestational body mass index (BMI), gestational age at delivery, neonatal birth weight, large for gestational age (LGA) and gender. This study demonstrates an association between high maternal glucose standard deviation before delivery and the risk for clinically significant neonatal hypoglycemia. Larger studies are needed to confirm these results and further explore the role of intrapartum glucose variability in the prediction and prevention of significant neonatal hypoglycemia.
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http://dx.doi.org/10.1080/09513590.2019.1698027DOI Listing
July 2020

Childhood Pancreatitis and Risk for Incident Diabetes in Adulthood.

Diabetes Care 2020 01 6;43(1):145-151. Epub 2019 Nov 6.

Department of Military Medicine, Hebrew University, Jerusalem, Israel

Objective: The relationship between acute pancreatitis and incident diabetes is unclear. We assessed whether a resolved single event of acute pancreatitis in childhood was associated with incident diabetes in adulthood.

Research Design And Methods: A nationwide, population-based study of 1,802,110 Israeli adolescents (mean age 17.4 years [range 16-20]) who were examined before compulsory military service between 1979 and 2008 and whose data were linked to the Israeli National Diabetes Registry (INDR). Resolved pancreatitis was defined as a history of a single event of acute pancreatitis with normal pancreatic function at enrollment. Logistic regression analysis was applied.

Results: Incident diabetes developed in 4.6% of subjects with resolved pancreatitis (13 of 281; none of these cases were identified as type 1 diabetes) and 2.5% among the unexposed group (44,463 of 1,801,716). Resolved acute pancreatitis was associated with incident diabetes with an odds ratio (OR) of 2.23 (95% CI 1.25-3.98) with adjustment for age, sex, and birth year. Findings persisted after further adjustments for baseline BMI and sociodemographic confounders (OR 2.10 [95% CI 1.15-3.84]). Childhood pancreatitis was associated with a diagnosis of diabetes at a younger age, with 92% of diabetes case subjects diagnosed before 40 years of age compared with 47% in the unexposed group ( = 0.002). The association accentuated when the study sample was limited to individuals of unimpaired health or normal BMI at baseline.

Conclusions: A history of acute pancreatitis in childhood with normal pancreatic function in late adolescence is a risk factor for incident type 2 diabetes, especially at young adulthood.
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http://dx.doi.org/10.2337/dc19-1562DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011197PMC
January 2020

Cognitive function in adolescence and the risk for premature diabetes and cardiovascular mortality in adulthood.

Cardiovasc Diabetol 2018 12 5;17(1):154. Epub 2018 Dec 5.

The Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Background: Epidemiological studies have demonstrated a relationship between cognitive function in youth and the future risk of death. Less is known regarding the relationship with diabetes related death. This study assessed the relationship between cognitive function in late adolescence and the risk for diabetes, cardiovascular- (CVD) and all-cause mortality in adulthood.

Methods: This retrospective study linked data from 2,277,188 16-19 year olds who had general intelligence tests (GIT) conducted during pre-military recruitment assessment with cause of death as coded by the Israel Central Bureau of Statistics. The associations between cognitive function and cause-specific mortality were assessed using Cox models.

Results: There were 31,268 deaths that were recorded during 41,916,603 person-years of follow-up, with a median follow-up of 19.2 (IQR 10.7, 29.5) years. 3068, 1443, 514 and 457 deaths were attributed to CVD, CHD, stroke, and diabetes, respectively. Individuals in the lowest GIT vs. highest GIT quintiles in unadjusted models had the highest risk for all-cause mortality (HR 1.84, 95% CI 1.78, 1.91), total CVD (HR 3.32, 95% CI 2.93, 3.75), CHD (HR 3.49 95% CI 2.92, 4.18), stroke (HR 3.96 95% CI 2.85, 5.5) and diabetes-related (HR 6.96 95% CI 4.68, 10.36) mortality. These HRs were attenuated following adjustment for age, sex, birth year, body-mass index, residential socioeconomic status, education and country of origin for all-cause (HR 1.23, 95% CI 1.17, 1.28), CVD (HR 1.76, 95% CI 1.52, 2.04), CHD (HR 1.7 95% CI 1.37, 2.11), stroke (HR 2.03, 95% CI 1.39, 2.98) and diabetes-related (HR 3.14 95% CI 2.00, 4.94) mortality. Results persisted in a sensitivity analyses limited to participants with unimpaired health at baseline and that accounted competing risk.

Conclusions: This analysis of over 2 million demonstrates a strong relationship between cognitive function at youth and the risk for diabetes, all-cause and CVD-related mortality independent of adolescent obesity.
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http://dx.doi.org/10.1186/s12933-018-0798-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280532PMC
December 2018

Effect of glycaemic control on cardiovascular disease in individuals with type 2 diabetes with pre-existing cardiovascular disease: A systematic review and meta-analysis.

Diabetes Obes Metab 2019 03 18;21(3):732-735. Epub 2018 Dec 18.

Sackler School of Medicine, School of Public Health, Tel Aviv University, Tel Aviv, Israel.

The role of intensive glucose control in people with type 2 diabetes and pre-existing cardiovascular disease (CVD) is controversial. The aim of this systematic review and meta-analysis was to determine in a subset of people with type 2 diabetes and pre-existing CVD, the CV effect of intensive glucose control versus standard of care. We searched Medline, the Cochrane library, EMBASE and the National Institutes of Health Trial registration database for randomized controlled trials that evaluated the effect of intensive glucose control versus standard glucose control in people with type 2 diabetes on incident CVD. Data were extracted using a structured form. When data were not available in the publications, authors were contacted. Eight trials involving 8339 participants were included. Among adults with type 2 diabetes and pre-existing CVD, there was no difference in the risk of CV events in those allocated to intensive glucose control compared with those in the standard care arm (relative risk 0.98, 95% confidence interval 0.87-1.09). In conclusion, in people with diabetes and pre-existing CVD, intensive glucose control versus standard care had a neutral effect on incident CV events.
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http://dx.doi.org/10.1111/dom.13581DOI Listing
March 2019

Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial.

Diabetes Care 2019 01 13;42(1):142-147. Epub 2018 Nov 13.

Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.

Objective: Epidemiological studies have reported a relationship between severe hypoglycemia, cognitive dysfunction, and dementia in middle-aged and older people with type 2 diabetes. However, whether severe or nonsevere hypoglycemia precedes cognitive dysfunction is unclear. Thus, the aim of this study was to analyze the relationship between hypoglycemia and incident cognitive dysfunction in a group of carefully followed patients using prospectively collected data in the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial.

Research Design And Methods: This prospective cohort analysis of data from a randomized controlled trial included individuals with dysglycemia who had additional cardiovascular risk factors and a Mini-Mental State Examination (MMSE) score ≥24 ( = 11,495). Severe and nonsevere hypoglycemic events were collected prospectively during a median follow-up time of 6.2 years. Incident cognitive dysfunction was defined as either reported dementia or an MMSE score of <24. The hazard of at least one episode of severe or nonsevere hypoglycemia for incident cognitive dysfunction (i.e., the dependent variable) from the time of randomization was estimated using a Cox proportional hazards model after adjusting for baseline cardiovascular disease, diabetes status, treatment allocation, and a propensity score for either form of hypoglycemia.

Results: This analysis did not demonstrate an association between severe hypoglycemia and incident cognitive impairment either before (hazard ratio [HR] 1.16; 95% CI 0.89, 1.52) or after (HR 1.00; 95% CI 0.76, 1.31) adjusting for the severe hypoglycemia propensities. Conversely, nonsevere hypoglycemia was inversely related to incident cognitive impairment both before (HR 0.59; 95% CI 0.52, 0.68) and after (HR 0.58; 95% CI 0.51, 0.67) adjustment.

Conclusions: Hypoglycemia did not increase the risk of incident cognitive dysfunction in 11,495 middle-aged individuals with dysglycemia.
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http://dx.doi.org/10.2337/dc18-0690DOI Listing
January 2019

Severe obesity and cardio-metabolic comorbidities: a nationwide study of 2.8 million adolescents.

Int J Obes (Lond) 2019 07 26;43(7):1391-1399. Epub 2018 Sep 26.

Sackler School of Medicine, Tel-Aviv University, Tel Aviv-Yafo, Israel.

Background: Severe obesity is rising among adolescents, but data on the prevalence of metabolic abnormalities among this group are limited. We assessed the secular trend of severe obesity and its association with major cardio-metabolic morbidities.

Methods: A total of 2,785,227 Israeli adolescents (aged 17.2 ± 0.5 years) who underwent a pre-recruitment medical examination including routine measurements of weight, height and blood pressure between 1967 and 2015 were included. In all, 230,639 adolescents with abnormally excessive BMI were classified into overweight, classes I, II, and III (severe) obesity. Logistic regression was applied to determine the association between BMI groups and prehypertension, high blood pressure and type 2 diabetes (T2DM).

Results: There was 45-fold increase in the prevalence of class III obesity during study period. Severe obesity was recorded in 2060 males and 1149 females, in whom nearly 35 and 43% had prehypertension or high blood pressure, respectively. Compared with adolescents with overweight, the odds ratios (ORs) for high blood pressure in classes II and III obesity groups, respectively, were 2.13 (95% CI, 2.04-2.23) and 2.86 (2.60-3.15) in males, and 2.59 (2.43-2.76) and 3.44 (3.04-3.90) in females, whereas the ORs for T2DM were 19.1 (12.3-29.6) and 38.0 (22.6-64.0) in males, and 15.1 (11.4-20.0) and 24.8 (17.2-35.7) in females. Results persisted in extensive sensitivity analyses including a longitudinal follow-up (median: males, 3.4 years; females, 4.9 years).

Conclusions: Severe obesity showed a marked secular increase and was associated with significantly higher risk for abnormal blood pressure and T2DM than lower degrees of obesity, in both males and females.
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http://dx.doi.org/10.1038/s41366-018-0213-zDOI Listing
July 2019

The Association between Mediterranean Diet and the Risk of Falls and Physical Function Indices in Older Type 2 Diabetic People Varies by Age.

Nutrients 2018 Jun 14;10(6). Epub 2018 Jun 14.

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 69978, Israel.

Background And Aims: Diabetes and dysglycemia increase the risk of frailty and decreased physical abilities. Adherence to the Mediterranean Diet (MD) may reduce this risk. We hypothesized that adherence to the MD is associated with physical function in older type-2 diabetic patients and that the association is stratified by age.

Methods And Results: We recruited type-2 diabetes patients aged >60 years at the Center for Successful Aging with Diabetes at Sheba Medical Center. Health status and demographic data were obtained from medical records. Food Frequency Questionnaire was used for nutritional assessment and calculation of MD score. Physical function indices were determined by a physiotherapist and included: Berg Balance test, Timed Get-Up-and-Go, 6-min walk (6 MW), 10-m walk (10 MW), Four Square Step Test, 30-s chair stand and Grip strength, and activities and instrumental activities of daily living. Among 117 participants (age 70.6 ± 6.5), high adherence to MD was associated with better score on functional tests (low vs. high MD adherence: 9.7% vs. 25%, ANOVA = 0.02). A significant age by MD interaction was found: a higher adherence to MD was associated with a better 6 MW (low vs. high: 387 ± 35 m vs. 483 ± 26 m; = 0.001) and higher 10 MW (low vs. high: 1.8 ± 0.16 m/s vs. 2.0 ± 0.13 m/s; = 0.02) in participants aged >75 years. These associations remained significant after controlling for gender, age, BMI, and physical activity.

Conclusion: In the current study, we showed relationships between strength, physical performance, and MD among older diabetic patients. Future studies are needed to confirm this association and establish temporal relationships.
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http://dx.doi.org/10.3390/nu10060767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6024581PMC
June 2018

Supporting a comprehensive and coordinated evaluation of the elderly with diabetes by integrating cognitive and physical assessment in the evaluation process.

Diabetes Metab Res Rev 2018 10 31;34(7):e3030. Epub 2018 Jul 31.

The "Segal" Center for Successful Aging with Diabetes, Endocrinology Institute, Sheba Medical Center, Ramat Gan, Israel.

Background: Successful ageing with diabetes is challenged by co-morbidities, which may present barriers to self-care. Currently, measurement of physical and cognitive status is not part of routine care of the older person with diabetes, and these are not taken into account when devising the treatment plan.

Objective: To describe a novel approach that integrates cognitive and physical assessment into the routine evaluation of the older person with diabetes and the tailor-made treatment plan devised accordingly. To provide estimates of the relative contribution of cognitive and physical disabilities in this population.

Methods: Cognitive and physical assessments were added to the standard evaluation. A composite measure of cognitive and of physical status categorizing each individual to intact, mild, or severe impairment was generated. In addition, all recommendations provided were categorized and tabulated.

Results: Of 119 individuals, over the age of 60 with type 2 diabetes who were referred because of difficulties in managing their disease, 16% and 3% of individuals met the criteria for severe cognitive/physical impairment, respectively, and 42% and 21% met the criteria for mild cognitive/physical impairment; 72%, 12.5%, 61% received recommendations related to intensification of physical activity, cognitive treatment, change in pharmacological agents, respectively. 25% were referred for further emotional treatment.

Conclusions: These data suggest that a substantial proportion of individuals with diabetes over the age of 60 may have cognitive/physical impairment. It highlights the importance of measuring these as part of the multidisciplinary evaluation and being able to provide a tailor made treatment plan.
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http://dx.doi.org/10.1002/dmrr.3030DOI Listing
October 2018

[FMR1 PREMUTATION CARRIERS - ARE THEY REALLY ASYMPTOMATIC?]

Harefuah 2018 Apr;157(4):241-244

The Child Development Center, Sheba Medical Center, Tel Hashomer.

Introduction: Fragile X Syndrome (FXS), the most common form of inherited mental retardation, is caused by a trinucleotide repeat expansion (CGG) in the 5'-untranslated region of the Fragile X Mental Retardation 1 (FMR1) gene located at Xq27.3. Patients with fragile X -related mental retardation, carry the full mutation CGG-repeat expansions (>200 CGG repeats), which are generally accompanied by hypermethylation of the promoter region, with the consequent transcriptional silencing of the FMR1 gene and absence of the encoded FMR1 protein (FMRP). Expansion of the CGG triplet number above the normal range (n=5-54) towards the so-called premutation status (n=55-199) is associated with increased risk for Fragile X-Associated Premature Ovarian Insufficiency (FXPOI) in females and Fragile X-Associated Tremor/ Ataxia Syndrome (FXTAS) predominantly in males. In addition, premutation women carriers are at increased risk for learning disabilities, as well as psychologic, endocrine, autoimmune and metabolic disorders. The observation that premutation carriers, both males and females, have increased FMR1 transcript levels, led researchers to suggest a similar molecular pathogenesis in both FXPOI and FXTAS. Two models have been proposed as the culprits of FXTAS and FXPOI: The toxic RNA gain-of-function model and the Repeat Associated Non-AUG initiated (RAN) translation protein toxicity model. The Fragile X Multidisciplinary Center in Sheba Medical Center, at Tel Hashomer includes a team of geneticists, fertility specialists, endocrinologists, psychologists and neurologists who work together in order to provide early detection of FMR1 premutation carriers and offer FMR1 premutation carriers and their families adequate multidisciplinary medical consultation, follow-up and care.
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April 2018

Disease Management plus Recommended Care versus Recommended Care Alone for Ambulatory Patients with Chronic Obstructive Pulmonary Disease.

Am J Respir Crit Care Med 2018 Jun;197(12):1565-1574

Clinical Research Institute, Kaplan Medical Center, Rechovot, Israel.

The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD. In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08). DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.
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http://dx.doi.org/10.1164/rccm.201711-2182OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6009010PMC
June 2018

The diabetic brain and cognition.

J Neural Transm (Vienna) 2017 11 1;124(11):1431-1454. Epub 2017 Aug 1.

The Center for Successful Aging with Diabetes, Endocrinology Institute, Gertner Institute, Sheba Medical Center, Epidemiology D., Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

The prevalence of both Alzheimer's disease (AD) and vascular dementia (VaD) is increasing with the aging of the population. Studies from the last several years have shown that people with diabetes have an increased risk for dementia and cognitive impairment. Therefore, the authors of this consensus review tried to elaborate on the role of diabetes, especially diabetes type 2 (T2DM) in both AD and VaD. Based on the clinical and experimental work of scientists from 18 countries participating in the International Congress on Vascular Disorders and on literature search using PUBMED, it can be concluded that T2DM is a risk factor for both, AD and VaD, based on a pathology of glucose utilization. This pathology is the consequence of a disturbance of insulin-related mechanisms leading to brain insulin resistance. Although the underlying pathological mechanisms for AD and VaD are different in many aspects, the contribution of T2DM and insulin resistant brain state (IRBS) to cerebrovascular disturbances in both disorders cannot be neglected. Therefore, early diagnosis of metabolic parameters including those relevant for T2DM is required. Moreover, it is possible that therapeutic options utilized today for diabetes treatment may also have an effect on the risk for dementia. T2DM/IRBS contribute to pathological processes in AD and VaD.
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http://dx.doi.org/10.1007/s00702-017-1763-2DOI Listing
November 2017

The Relationship Between the Score on a Simple Measure of Cognitive Function and Incident CVD in People With Diabetes: A Post Hoc Epidemiological Analysis From the ACCORD-MIND Study.

J Clin Endocrinol Metab 2017 09;102(9):3218-3225

Department of Neurology, The University of Alabama at Birmingham, Birmingham, Alabama 35294.

Context And Objective: Diabetes is associated with a greater risk for incident cardiovascular disease and cognitive dysfunction. This study aimed to investigate, in people with type 2 diabetes, the association of a simple measure of cognitive function to cardiovascular disease events and mortality.

Design, Setting, Participants, Measurements, And Outcomes: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial included persons with longstanding type 2 diabetes. A substudy of 2977 (Memory in Diabetes) participants aged 55 years or older aimed to test the effect of the interventions on brain structure and function. At baseline, participants were administered a cognitive battery that included the digit symbol substitution test (DSST). The associations of the DSST and the ACCORD primary outcome (the first occurrence of nonfatal myocardial infarction or nonfatal stroke or death from cardiovascular causes) and all-cause mortality were investigated with Cox proportional hazard models adjusting for several demographic and clinical variables.

Results: Median follow-up time was 4.27 years. An inverse relationship between the incidence of the ACCORD primary outcome and baseline cognitive score was demonstrated. A 1-point higher DSST score was associated with a lower incidence of the primary outcome (hazard ratio, 0.987; 95% confidence interval, 0.977 to 0.998; P = 0.019), after adjustment for demographic and clinical trial factors, additional baseline cardiovascular risk factors, and self-reported need for assistance to follow the protocol.

Conclusion: Lower scores on the DSST, a simple, sensitive neuropsychological instrument, are associated with a higher incidence of cardiovascular events in persons >55 years old with longstanding diabetes.
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http://dx.doi.org/10.1210/jc.2016-3480DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587069PMC
September 2017

Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

BMC Med 2017 05 1;15(1):90. Epub 2017 May 1.

Maccabi Healthcare Services, Tel Aviv, Israel.

Background: The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies.

Methods: In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center.

Results: During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up.

Conclusions: This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint, but it improved health-related quality of life and depression. A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care.

Clinical Trial Registration: Clinicaltrials.gov identifier: NCT00533013 . Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.
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http://dx.doi.org/10.1186/s12916-017-0855-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5410698PMC
May 2017

Cognitive Dysfunction: Part and Parcel of the Diabetic Foot.

Diabetes Care 2016 Jul 13;39(7):1202-7. Epub 2016 May 13.

Endocrinology Institute, Sheba Medical Center, Ramat Gan, Israel Gertner Institute Sheba Medical Center, Tel Hashomer, Israel Epidemiology Department, Tel Aviv University, Tel Aviv, Israel.

Objective: The presence of a foot ulcer increases the self-treatment burden imposed on the individual with diabetes. Additionally, this condition increases the cognitive demands needed for adherence to medical recommendations. A potential gap could exist between medical recommendations and the individual's ability to implement them. Hence, the goal of this study was to examine whether the cognitive profile of people with diabetic foot ulcers differs from that of people with diabetes without this complication.

Research Design And Methods: This was a case-control study. Ninety-nine individuals with diabetic foot ulcers (case patients) and 95 individuals with type 2 diabetes (control subjects) (age range 45-75 years), who were matched for diabetes duration and sex, underwent extensive neuropsychological evaluation using a NeuroTrax computerized battery, digit symbol, and verbal fluency tests. A global cognitive score after standardization for age and education was computed as well as scores in the following six cognitive domains: memory, executive function, reaction time, attention, psychomotor abilities, and estimated premorbid cognition.

Results: Individuals with diabetic foot ulcers had significantly (P < 0.001) lower cognitive scores than individuals with diabetes without this complication, in all tested cognitive domains, excluding estimated premorbid cognition. Individuals with diabetic foot ulcers demonstrated a significant difference between precognitive and current cognitive abilities, as opposed to the nonsignificant difference among control subjects. The differences persisted in multivariable analysis after adjusting for depression and smoking.

Conclusions: Individuals with diabetic foot ulcers were found to possess fewer cognitive resources than individuals with diabetes without this complication. Thus, they appear to face more self-treatment challenges, while possessing significantly fewer cognitive resources.
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http://dx.doi.org/10.2337/dc15-2838DOI Listing
July 2016