Publications by authors named "Petra J M Elders"

80 Publications

Insulin resistance as a marker for the immune-metabolic subtype of depression.

J Affect Disord 2021 Sep 1. Epub 2021 Sep 1.

Amsterdam UMC and GGZ inGeest, Dept. of Psychiatry, Amsterdam Public Health Research Institute, Vrije Universiteit, De Boelelaan 1117, 1081 HV, Postbus, 7075, 1007 MB, Amsterdam, the Netherlands.

Objective: Insulin resistance (IR), a marker of metabolic dysregulation and pro-inflammatory state, moderates the antidepressant treatment effect in patients with type 2 diabetes (T2D) and is therefore a potential marker for personalized treatment. Based on data from a light therapy trial (NTR4942), we aimed to evaluate whether 1) depression symptoms differ according to the level of IR, and 2) improvement of specific depression symptoms drive the positive effects of light therapy in those with higher IR.

Methods: This secondary analysis in 59 individuals with depression and T2D explored differences in depressive symptom profile (30-item Inventory of Depressive Symptomatology (IDS)) at baseline and in response to light therapy (versus placebo), between lower and higher IR individuals, using Likelihood Ratio tests and Linear-by-linear association. IR was measured using the gold standard, a hyperinsulinemic-euglycaemic clamp.

Results: At baseline, higher IR individuals reported more symptoms of irritability (p=0.024) anhedonia (no interest in people and activities: p=0.011; absence of pleasure and enjoyment: p=0.021), fatigue (fatigue: p=0.036; physical fatigue: p=0.035) and hypersomnia (p=0.029) relative to persons with lower IR, who reported more insomnia (nightly awakening: p=0.041; early morning awakening: p=0.012). Light therapy led to an improvement across IDS symptoms in higher IR individuals, while in lower IR individuals, light therapy improved early morning awakening (p=0.005) and interest in people and activities (p=0.015), but worsened mood (feeling sad: p=0.001; feeling irritable: p=0.002; interpersonal sensitivity: p=0.014).

Conclusions: Results add to the hypothesis of an immune-metabolic subtype of depression, and suggest that IR might be a promising focus for precision medicine.
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http://dx.doi.org/10.1016/j.jad.2021.08.151DOI Listing
September 2021

The role of serum and dietary advanced glycation endproducts in relation to cardiac function and structure: The Hoorn Study.

Nutr Metab Cardiovasc Dis 2021 Jul 27. Epub 2021 Jul 27.

Department of Epidemiology & Data Science, Amsterdam UMC-location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, the Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.

Background And Aims: This study aims to investigate the relationship of serum and dietary advanced glycation endproducts (AGEs) with cardiac function and structure after eight years of follow-up.

Methods And Results: We included 370 Hoorn Study participants (aged 66.4 ± 6.1, 47% women). Serum protein-bound AGEs [N-(carboxymethyl)lysine, N-(carboxyethyl)lysine, and pentosidine], as well as echocardiography to assess left atrium volume index (LAVI), left ventricle ejection fraction (LVEF), and left ventricle mass index (LVMI), were measured at baseline and after 8 years of follow-up. Dietary AGEs [N-(carboxymethyl)lysine and N-(carboxyethyl)lysine] were estimated at baseline with a validated food-frequency questionnaire and an AGEs database. Increased pentosidine [-1.4% (-2.6;-0.2)] and overall serum AGEs Z-scores over time [-2.1% (-3.8;-0.5)] were associated with decreased LVEF at follow-up, adjusted for confounders. Glucose metabolism status was an effect modifier (P-for-interaction = 0.04). In participants with impaired glucose metabolism, but not type 2 diabetes, increased pentosidine was associated with decreased LVEF [-4.2 (-8.0;-0.3)%]. Higher dietary N-(carboxyethyl)lysine [1.9 (0.1; 3.7)%] and overall dietary AGEs Z-scores [2.1 (0.1; 4.2)%] were associated with higher LVEF at follow-up. However, prior cardiovascular disease (CVD) was an effect modifier (P = 0.02). We found a stronger, non-significant, association of higher dietary (carboxyethyl)lysine with higher LVEF at follow-up in participants without CVD [2.3 (-0.1; 4.7)%] compared to participants with CVD [0.6 (-2.1; 3.4)%].

Conclusion: Overall serum AGEs were longitudinally associated with impaired systolic function. Future research should focus on including changes in dietary AGEs intake over time and the relation of dietary AGEs with cardiac measures needs to be established in intervention studies using low AGEs diets.
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http://dx.doi.org/10.1016/j.numecd.2021.07.020DOI Listing
July 2021

Magnesium intake and vascular structure and function: the Hoorn Study.

Eur J Nutr 2021 Sep 7. Epub 2021 Sep 7.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Institute, Amsterdam UMC, Location VUmc, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Purpose: Circulating and dietary magnesium have been shown to be inversely associated with the prevalence of cardiovascular disease (CVD) and mortality in both high and low-risk populations. We aimed to examine the association between dietary magnesium intake and several measures of vascular structure and function in a prospective cohort.

Methods: We included 789 participants who participated in the vascular screening sub-cohort of the Hoorn Study, a population-based, prospective cohort study. Baseline dietary magnesium intake was estimated with a validated food frequency questionnaire and categorised in energy-adjusted magnesium intake tertiles. Several measurements of vascular structure and function were performed at baseline and most measurements were repeated after 8 years of follow-up (n = 432). Multivariable linear and logistic regression was performed to study the cross-sectional and longitudinal associations of magnesium intake and intima-media thickness (IMT), augmentation index (Aix), pulse wave velocity (PWV), flow-mediated dilatation (FMD), and peripheral arterial disease (PAD).

Results: Mean absolute magnesium intake was 328 ± 83 mg/day and prior CVD and DM2 was present in 55 and 41% of the participants, respectively. Multivariable regression analyses did not demonstrate associations between magnesium intake and any of the vascular outcomes. Participants in the highest compared to the lowest magnesium intake tertile demonstrated in fully adjusted cross-sectional analyses a PWV of -0.21 m/s (95% confidence interval -1.95, 1.52), a FMD of -0.03% (-0.89, 0.83) and in longitudinal analyses an IMT of 0.01 mm (-0.03, 0.06), an Aix of 0.70% (-1.69, 3.07) and an odds ratio of 0.84 (0.23, 3.11) for PAD CONCLUSION: We did not find associations between dietary magnesium intake and multiple markers of vascular structure and function, in either cross-sectional or longitudinal analyses.
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http://dx.doi.org/10.1007/s00394-021-02667-0DOI Listing
September 2021

Sleep disorders in people with type 2 diabetes and associated health outcomes: a review of the literature.

Diabetologia 2021 Nov 16;64(11):2367-2377. Epub 2021 Aug 16.

Department of Epidemiology and Data Science, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands.

Sleep disorders are linked to development of type 2 diabetes and increase the risk of developing diabetes complications. Treating sleep disorders might therefore play an important role in the prevention of diabetes progression. However, the detection and treatment of sleep disorders are not part of standardised care for people with type 2 diabetes. To highlight the importance of sleep disorders in people with type 2 diabetes, we provide a review of the literature on the prevalence of sleep disorders in type 2 diabetes and the association between sleep disorders and health outcomes, such as glycaemic control, microvascular and macrovascular complications, depression, mortality and quality of life. Additionally, we examine the extent to which treating sleep disorders in people with type 2 diabetes improves these health outcomes. We performed a literature search in PubMed from inception until January 2021, using search terms for sleep disorders, type 2 diabetes, prevalence, treatment and health outcomes. Both observational and experimental studies were included in the review. We found that insomnia (39% [95% CI 34, 44]), obstructive sleep apnoea (55-86%) and restless legs syndrome (8-45%) were more prevalent in people with type 2 diabetes, compared with the general population. No studies reported prevalence rates for circadian rhythm sleep-wake disorders, central disorders of hypersomnolence or parasomnias. Additionally, several cross-sectional and prospective studies showed that sleep disorders negatively affect health outcomes in at least one diabetes domain, especially glycaemic control. For example, insomnia is associated with increased HbA levels (2.51 mmol/mol [95% CI 1.1, 4.4]; 0.23% [95% CI 0.1, 0.4]). Finally, randomised controlled trials that investigate the effect of treating sleep disorders in people with type 2 diabetes are scarce, based on a small number of participants and sometimes inconclusive. Conventional therapies such as weight loss, sleep education and cognitive behavioural therapy seem to be effective in improving sleep and health outcomes in people with type 2 diabetes. We conclude that sleep disorders are highly prevalent in people with type 2 diabetes, negatively affecting health outcomes. Since treatment of the sleep disorder could prevent diabetes progression, efforts should be made to diagnose and treat sleep disorders in type 2 diabetes in order to ultimately improve health and therefore quality of life.
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http://dx.doi.org/10.1007/s00125-021-05541-0DOI Listing
November 2021

Serum Magnesium Is Inversely Associated With Heart Failure, Atrial Fibrillation, and Microvascular Complications in Type 2 Diabetes.

Diabetes Care 2021 08 18;44(8):1757-1765. Epub 2021 Jun 18.

Department of Physiology, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands

Objective: We investigated whether serum magnesium (Mg) was prospectively associated with macro- or microvascular complications and mediated by glycemic control (hemoglobin A [HbA]), in type 2 diabetes (T2D).

Research Design And Methods: We analyzed in 4,348 participants the association of serum Mg with macrovascular disease and mortality (acute myocardial infarction [AMI], coronary heart disease [CHD], heart failure [HF], cerebrovascular accident [CVA], and peripheral arterial disease [PAD]), atrial fibrillation (AF), and microvascular complications (chronic kidney disease [CKD], diabetic retinopathy, and diabetic foot) using Cox regression, adjusted for confounders. Mediation analysis was performed to assess whether HbA mediated these associations.

Results: The average baseline serum Mg concentration was 0.80 ± 0.08 mmol/L. During 6.1 years of follow-up, serum Mg was inversely associated with major macrovascular, 0.87 (95% CI 0.76; 1.00); HF, 0.76 (95% CI 0.62; 0.93); and AF, 0.59 (95% CI 0.49; 0.72). Serum Mg was not associated with AMI, CHD, CVA, and PAD. During 5.1 years of follow-up, serum Mg was inversely associated with overall microvascular events, 0.85 (95% CI 0.78; 0.91); 0.89 (95% CI 0.82; 0.96) for CKD, 0.77 (95% CI 0.61; 0.98) for diabetic retinopathy, and 0.85 (95% CI 0.78; 0.92) for diabetic foot. HbA mediated the associations of serum Mg with HF, overall microvascular events, diabetic retinopathy, and diabetic foot.

Conclusions: Serum Mg concentration is inversely associated with the risk to develop HF and AF and with the occurrence of CKD, diabetic retinopathy, and foot complications in T2D. Glycemic control partially mediated the association of serum Mg with HF and microvascular complications.
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http://dx.doi.org/10.2337/dc21-0236DOI Listing
August 2021

Dairy product consumption and incident prediabetes in Dutch middle-aged adults: the Hoorn Studies prospective cohort.

Eur J Nutr 2021 Jul 10. Epub 2021 Jul 10.

Center of Research on Psychological and Somatic Disorders (CORPS), Department of Medical and Clinical Psychology, Tilburg University, PO Box 90153, 5000 LE, Tilburg, The Netherlands.

Purpose: Our aim was to investigate prospective associations of consumption of total dairy and dairy types with incident prediabetes in a Dutch population-based study.

Methods: Two enrolment waves of the Hoorn Studies were harmonized, resulting in an analytic sample of 2262 participants without (pre-) diabetes at enrolment (mean age 56 ± 7.3 years; 50% male). Baseline dietary intake was assessed by validated food frequency questionnaires. Relative risks (RRs) were calculated between dairy, fermented dairy, milk, yogurt (all total/high/low fat), cream and ice cream and prediabetes. Additionally, substituting one serving/day of dairy types associated with prediabetes with alternative dairy types was analysed.

Results: During a mean 6.4 ± 0.7 years of follow-up, 810 participants (35.9%) developed prediabetes. High fat fermented dairy, cheese and high fat cheese were associated with a 17% (RR 0.83, 95% CI 0.69-0.99, p = 0.04), 14% (RR 0.86, 95% CI 0.73-1.02, p = 0.04) and 21% (RR 0.79, 95% CI 0.66-0.94, p = 0.01) lower risk of incident prediabetes, respectively, in top compared to bottom quartiles, after adjustment for confounders. High fat cheese consumption was continuously associated with lower prediabetes risk (RR 0.94, 95% CI 0.88-1.00, p = 0.04). Total dairy and other dairy types were not associated with prediabetes risk in adjusted models, irrespective of fat content (RR ~ 1). Replacing high fat cheese with alternative dairy types was not associated with prediabetes risk.

Conclusion: The highest intake of high fat fermented dairy, cheese and high fat cheese were associated with a lower risk of prediabetes, whereas other dairy types were not associated. Cheese seems to be inversely associated with type 2 diabetes risk, despite high levels of saturated fatty acids and sodium.
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http://dx.doi.org/10.1007/s00394-021-02626-9DOI Listing
July 2021

Profiles of Glucose Metabolism in Different Prediabetes Phenotypes, Classified by Fasting Glycemia, 2-Hour OGTT, Glycated Hemoglobin, and 1-Hour OGTT: An IMI DIRECT Study.

Diabetes 2021 Sep 7;70(9):2092-2106. Epub 2021 Jul 7.

Department of Epidemiology and Data Science, Amsterdam Medical Centre, location VUMC, Amsterdam, the Netherlands.

Differences in glucose metabolism among categories of prediabetes have not been systematically investigated. In this longitudinal study, participants ( = 2,111) underwent a 2-h 75-g oral glucose tolerance test (OGTT) at baseline and 48 months. HbA was also measured. We classified participants as having isolated prediabetes defect (impaired fasting glucose [IFG], impaired glucose tolerance [IGT], or HbA indicative of prediabetes [IA1c]), two defects (IFG+IGT, IFG+IA1c, or IGT+IA1c), or all defects (IFG+IGT+IA1c). β-Cell function (BCF) and insulin sensitivity were assessed from OGTT. At baseline, in pooling of participants with isolated defects, they showed impairment in both BCF and insulin sensitivity compared with healthy control subjects. Pooled groups with two or three defects showed progressive further deterioration. Among groups with isolated defect, those with IGT showed lower insulin sensitivity, insulin secretion at reference glucose (ISR), and insulin secretion potentiation ( < 0.002). Conversely, those with IA1c showed higher insulin sensitivity and ISR ( < 0.0001). Among groups with two defects, we similarly found differences in both BCF and insulin sensitivity. At 48 months, we found higher type 2 diabetes incidence for progressively increasing number of prediabetes defects (odds ratio >2, < 0.008). In conclusion, the prediabetes groups showed differences in type/degree of glucometabolic impairment. Compared with the pooled group with isolated defects, those with double or triple defect showed progressive differences in diabetes incidence.
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http://dx.doi.org/10.2337/db21-0227DOI Listing
September 2021

Sex differences in the longitudinal relationship of low-grade inflammation and echocardiographic measures in the Hoorn and FLEMENGHO Study.

PLoS One 2021 4;16(5):e0251148. Epub 2021 May 4.

Department of Epidemiology & Data Science, Amsterdam UMC, Amsterdam Cardiovascular Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Background: This study aimed to determine the within-person and between-persons associations of low-grade inflammation (LGI) and endothelial dysfunction (ED) with echocardiographic measures related to diastolic dysfunction (DD) in two general populations and whether these associations differed by sex.

Methods: Biomarkers and echocardiographic measures were measured at both baseline and follow-up in the Hoorn Study (n = 383) and FLEMENGHO (n = 491). Individual biomarker levels were combined into either a Z-score of LGI (CRP, SAA, IL-6, IL-8, TNF-α and sICAM-1) or ED (sICAM-1, sVCAM-1, sE-selectin and sTM). Mixed models were used to determine within-person and between-persons associations of biomarker Z-scores with left ventricular ejection fraction (LVEF), left ventricular mass index (LVMI) and left atrial volume index (LAVI). These associations were adjusted for a-priori selected confounders.

Results: Overall Z-scores for LGI or ED were not associated with echocardiographic measures. Effect modification by sex was apparent for ED with LVEF in both cohorts (P-for interaction = 0.08 and 0.06), but stratified results were not consistent. Effect modification by sex was apparent for TNF-α in the Hoorn Study and E-selectin in FLEMENGHO with LVEF (P-for interaction≤0.05). In the Hoorn Study, women whose TNF-α levels increased with 1-SD over time had a decrease in LVEF of 2.2 (-4.5;0.01) %. In FLEMENGHO, men whose E-selectin levels increased with 1-SD over time had a decrease in LVEF of 1.6 (-2.7;-0.5) %.

Conclusion: Our study did not show consistent associations of LGI and ED with echocardiographic measures. Some evidence of effect modification by sex was present for ED and specific biomarkers.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0251148PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096104PMC
May 2021

Prognostic models for predicting the risk of foot ulcer or amputation in people with type 2 diabetes: a systematic review and external validation study.

Diabetologia 2021 Jul 27;64(7):1550-1562. Epub 2021 Apr 27.

Department of General Practice, Amsterdam UMC - Location VUmc, Amsterdam Public Health, Amsterdam, the Netherlands.

Aims/hypothesis: Approximately 25% of people with type 2 diabetes experience a foot ulcer and their risk of amputation is 10-20 times higher than that of people without type 2 diabetes. Prognostic models can aid in targeted monitoring but an overview of their performance is lacking. This study aimed to systematically review prognostic models for the risk of foot ulcer or amputation and quantify their predictive performance in an independent cohort.

Methods: A systematic review identified studies developing prognostic models for foot ulcer or amputation over minimal 1 year follow-up applicable to people with type 2 diabetes. After data extraction and risk of bias assessment (both in duplicate), selected models were externally validated in a prospective cohort with a 5 year follow-up in terms of discrimination (C statistics) and calibration (calibration plots).

Results: We identified 21 studies with 34 models predicting polyneuropathy, foot ulcer or amputation. Eleven models were validated in 7624 participants, of whom 485 developed an ulcer and 70 underwent amputation. The models for foot ulcer showed C statistics (95% CI) ranging from 0.54 (0.54, 0.54) to 0.81 (0.75, 0.86) and models for amputation showed C statistics (95% CI) ranging from 0.63 (0.55, 0.71) to 0.86 (0.78, 0.94). Most models underestimated the ulcer or amputation risk in the highest risk quintiles. Three models performed well to predict a combined endpoint of amputation and foot ulcer (C statistics >0.75).

Conclusions/interpretation: Thirty-four prognostic models for the risk of foot ulcer or amputation were identified. Although the performance of the models varied considerably, three models performed well to predict foot ulcer or amputation and may be applicable to clinical practice.
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http://dx.doi.org/10.1007/s00125-021-05448-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8075833PMC
July 2021

An elevated ankle-brachial index is not a valid proxy for peripheral medial arterial calcification.

Atherosclerosis 2021 04 13;323:13-19. Epub 2021 Mar 13.

Amsterdam UMC, location VUmc, Department of Epidemiology & Data Science, Amsterdam Cardiovascular Sciences, De Boelelaan, 1117, Amsterdam, the Netherlands; University Medical Centre Utrecht, Utrecht University, Julius Center for Health Sciences and Primary Care, Utrecht, the Netherlands.

Background And Aims: The ankle brachial index (ABI) is often used as a proxy for medial arterial calcification (MAC) in studies investigating MAC as a cardiovascular risk factor, but evidence supporting this hypothesis is sparse. This study aims to investigate the use of an elevated ABI as proxy for MAC, as visualized with computed tomography (CT).

Methods: Cross-sectional data of 718 participants with, or at risk of cardiovascular disease was used. The ABI was calculated using cutoffs >1.4 and > 1.3. The presence of MAC was assessed in the crural and femoral arteries by CT imaging. Modified Poisson regression was used to assess the association between an elevated ABI and the presence of MAC, and test characteristics were calculated.

Results: MAC was found in 25.0% of participants. An ABI >1.4 was found in 8.7% of participants, of whom 45.2% had MAC. An elevated ABI was significantly associated with the presence of MAC (RR 1.74, CI: 1.26-2.40). However, poor positive specific agreement (23.3%, CI: 13.9-34.3), sensitivity (15.7%, CI: 10.4-21.1) and positive predictive value (45.2%, CI: 32.8-57.5) were found. Despite good specificity (93.6%, CI: 91.6-95.7) the area under the receiving operator curve remained poor (54.7%, CI: 51.8-57.6). Negative specific agreement (84.5%, CI: 81.4-87.0) and negative predictive value (77.0%, CI: 73.7-80.2) were acceptable.

Conclusions: An elevated ABI is insufficient to serve as a true diagnostic proxy for MAC. Studies that have drawn conclusions on the association between MAC and cardiovascular disease, solely based on the ABI, are likely to underestimate the found effects.
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http://dx.doi.org/10.1016/j.atherosclerosis.2021.03.010DOI Listing
April 2021

Are Anticholinergic Symptoms a Risk Factor for Falls in Older General Practice Patients With Polypharmacy? Study Protocol for the Development and Validation of a Prognostic Model.

Front Pharmacol 2020 14;11:577747. Epub 2021 Jan 14.

Institute of General Practice, Goethe-University Frankfurt, Frankfurt, Germany.

: Cumulative anticholinergic exposure, also known as anticholinergic burden, is associated with a variety of adverse outcomes. However, studies show that anticholinergic effects tend to be underestimated by prescribers, and anticholinergics are the most frequently prescribed potentially inappropriate medication in older patients. The grading systems and drugs included in existing scales to quantify anticholinergic burden differ considerably and do not adequately account for patients' susceptibility to medications. Furthermore, their ability to link anticholinergic burden with adverse outcomes such as falls is unclear. This study aims to develop a prognostic model that predicts falls in older general practice patients, to assess the performance of several anticholinergic burden scales, and to quantify the added predictive value of anticholinergic symptoms in this context. : Data from two cluster-randomized controlled trials investigating medication optimization in older general practice patients in Germany will be used. One trial (RIME, n = 1,197) will be used for the model development and the other trial (PRIMUM, n = 502) will be used to externally validate the model. A priori, candidate predictors will be selected based on a literature search, predictor availability, and clinical reasoning. Candidate predictors will include socio-demographics (e.g. age, sex), morbidity (e.g. single conditions), medication (e.g. polypharmacy, anticholinergic burden as defined by scales), and well-being (e.g. quality of life, physical function). A prognostic model including sociodemographic and lifestyle-related factors, as well as variables on morbidity, medication, health status, and well-being, will be developed, whereby the prognostic value of extending the model to include additional patient-reported symptoms will be also assessed. Logistic regression will be used for the binary outcome, which will be defined as "no falls" vs. "≥1 fall" within six months of baseline, as reported in patient interviews. : As the ability of different anticholinergic burden scales to predict falls in older patients is unclear, this study may provide insights into their relative importance as well as into the overall contribution of anticholinergic symptoms and other patient characteristics. The results may support general practitioners in their clinical decision-making and in prescribing fewer medications with anticholinergic properties.
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http://dx.doi.org/10.3389/fphar.2020.577747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845421PMC
January 2021

Predicting negative health outcomes in older general practice patients with chronic illness: Rationale and development of the PROPERmed harmonized individual participant data database.

Mech Ageing Dev 2021 03 15;194:111436. Epub 2021 Jan 15.

Institute of General Practice, Goethe University Frankfurt, 60590, Frankfurt am Main, Germany; Department of General Practice and Family Medicine, Medical Faculty OWL, University of Bielefeld, 33615, Bielefeld, Germany.

The prevalence of multimorbidity and polypharmacy increases significantly with age and are associated with negative health consequences. However, most current interventions to optimize medication have failed to show significant effects on patient-relevant outcomes. This may be due to ineffectiveness of interventions themselves but may also reflect other factors: insufficient sample sizes, heterogeneity of population. To address this issue, the international PROPERmed collaboration was set up to obtain/synthesize individual participant data (IPD) from five cluster-randomized trials. The trials took place in Germany and The Netherlands and aimed to optimize medication in older general practice patients with chronic illness. PROPERmed is the first database of IPD to be drawn from multiple trials in this patient population and setting. It offers the opportunity to derive prognostic models with increased statistical power for prediction of patient-relevant outcomes resulting from the interplay of multimorbidity and polypharmacy. This may help patients from this heterogeneous group to be stratified according to risk and enable clinicians to identify patients that are likely to benefit most from resource/time-intensive interventions. The aim of this manuscript is to describe the rationale behind PROPERmed collaboration, characteristics of the included studies/participants, development of the harmonized IPD database and challenges faced during this process.
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http://dx.doi.org/10.1016/j.mad.2021.111436DOI Listing
March 2021

Sleep characteristics across the lifespan in 1.1 million people from the Netherlands, United Kingdom and United States: a systematic review and meta-analysis.

Nat Hum Behav 2021 01 16;5(1):113-122. Epub 2020 Nov 16.

Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, the Netherlands.

We aimed to obtain reliable reference charts for sleep duration, estimate the prevalence of sleep complaints across the lifespan and identify risk indicators of poor sleep. Studies were identified through systematic literature search in Embase, Medline and Web of Science (9 August 2019) and through personal contacts. Eligible studies had to be published between 2000 and 2017 with data on sleep assessed with questionnaires including ≥100 participants from the general population. We assembled individual participant data from 200,358 people (aged 1-100 years, 55% female) from 36 studies from the Netherlands, 471,759 people (40-69 years, 55.5% female) from the United Kingdom and 409,617 people (≥18 years, 55.8% female) from the United States. One in four people slept less than age-specific recommendations, but only 5.8% slept outside of the 'acceptable' sleep duration. Among teenagers, 51.5% reported total sleep times (TST) of less than the recommended 8-10 h and 18% report daytime sleepiness. In adults (≥18 years), poor sleep quality (13.3%) and insomnia symptoms (9.6-19.4%) were more prevalent than short sleep duration (6.5% with TST < 6 h). Insomnia symptoms were most frequent in people spending ≥9 h in bed, whereas poor sleep quality was more frequent in those spending <6 h in bed. TST was similar across countries, but insomnia symptoms were 1.5-2.9 times higher in the United States. Women (≥41 years) reported sleeping shorter times or slightly less efficiently than men, whereas with actigraphy they were estimated to sleep longer and more efficiently than man. This study provides age- and sex-specific population reference charts for sleep duration and efficiency which can help guide personalized advice on sleep length and preventive practices.
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http://dx.doi.org/10.1038/s41562-020-00965-xDOI Listing
January 2021

A prognostic model predicted deterioration in health-related quality of life in older patients with multimorbidity and polypharmacy.

J Clin Epidemiol 2021 02 13;130:1-12. Epub 2020 Oct 13.

Institute of General Practice, Goethe University, 60590 Frankfurt am Main, Germany; Department of General Practice and Family Medicine, Medical Faculty OWL, University of Bielefeld, 33615 Bielefeld, Germany.

Objectives: To develop and validate a prognostic model to predict deterioration in health-related quality of life (dHRQoL) in older general practice patients with at least one chronic condition and one chronic prescription.

Study Design And Setting: We used individual participant data from five cluster-randomized trials conducted in the Netherlands and Germany to predict dHRQoL, defined as a decrease in EQ-5D-3 L index score of ≥5% after 6-month follow-up in logistic regression models with stratified intercepts to account for between-study heterogeneity. The model was validated internally and by using internal-external cross-validation (IECV).

Results: In 3,582 patients with complete data, of whom 1,046 (29.2%) showed deterioration in HRQoL, and 12/87 variables were selected that were related to single (chronic) conditions, inappropriate medication, medication underuse, functional status, well-being, and HRQoL. Bootstrap internal validation showed a C-statistic of 0.71 (0.69 to 0.72) and a calibration slope of 0.88 (0.78 to 0.98). In the IECV loop, the model provided a pooled C-statistic of 0.68 (0.65 to 0.70) and calibration-in-the-large of 0 (-0.13 to 0.13). HRQoL/functionality had the strongest prognostic value.

Conclusion: The model performed well in terms of discrimination, calibration, and generalizability and might help clinicians identify older patients at high risk of dHRQoL.

Registration: PROSPERO ID: CRD42018088129.
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http://dx.doi.org/10.1016/j.jclinepi.2020.10.006DOI Listing
February 2021

Sex differences in cardiometabolic risk factors, pharmacological treatment and risk factor control in type 2 diabetes: findings from the Dutch Diabetes Pearl cohort.

BMJ Open Diabetes Res Care 2020 10;8(1)

Department of Internal Medicine, School for Cardiovascular Diseases CARIM, Maastricht University Medical Centre+, Maastricht, The Netherlands.

Introduction: Sex differences in cardiometabolic risk factors and their management in type 2 diabetes (T2D) have not been fully identified. Therefore, we aimed to examine differences in cardiometabolic risk factor levels, pharmacological treatment and achievement of risk factor control between women and men with T2D.

Research Design And Methods: Cross-sectional data from the Dutch Diabetes Pearl cohort were used (n=6637, 40% women). Linear and Poisson regression analyses were used to examine sex differences in cardiometabolic risk factor levels, treatment, and control.

Results: Compared with men, women had a significantly higher body mass index (BMI) (mean difference 1.79 kg/m (95% CI 1.49 to 2.08)), while no differences were found in hemoglobin A (HbA) and systolic blood pressure (SBP). Women had lower diastolic blood pressure (-1.94 mm Hg (95% CI -2.44 to -1.43)), higher total cholesterol (TC) (0.44 mmol/L (95% CI 0.38 to 0.51)), low-density lipoprotein cholesterol (LDL-c) (0.26 mmol/L (95% CI 0.22 to 0.31)), and high-density lipoprotein cholesterol (HDL-c) sex-standardized (0.02 mmol/L (95% CI 0.00 to 0.04)), and lower TC:HDL ratio (-0.29 (95% CI -0.36 to -0.23)) and triglycerides (geometric mean ratio 0.91 (95% CI 0.85 to 0.98)). Women had a 16% higher probability of being treated with antihypertensive medication in the presence of high cardiovascular disease (CVD) risk and elevated SBP than men (relative risk 0.84 (95% CI 0.73 to 0.98)), whereas no sex differences were found for glucose-lowering medication and lipid-modifying medication. Among those treated, women were less likely to achieve treatment targets of HbA (0.92 (95% CI 0.87 to 0.98)) and LDL-c (0.89 (95% CI 0.85 to 0.92)) than men, while no differences for SBP were found.

Conclusions: In this Dutch T2D population, women had a slightly different cardiometabolic risk profile compared with men and a substantially higher BMI. Women had a higher probability of being treated with antihypertensive medication in the presence of high CVD risk and elevated SBP than men, and were less likely than men to achieve treatment targets for HbA and LDL levels.
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http://dx.doi.org/10.1136/bmjdrc-2020-001365DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539590PMC
October 2020

[Osteoporosis and increased risk of fractures].

Ned Tijdschr Geneeskd 2020 08 17;164. Epub 2020 Aug 17.

Amsterdam UMC, locatie VUmc, afd. Interne Geneeskunde en Endocrinologie,Amsterdam.

Osteoporosis is a common condition in older people. This condition leads to increased risk of fractures and is associated with morbidity and mortality. The number of patients with osteoporosis will increase significantly in the years to come due to the increasing numbers of older people and increasing life expectancy. This will be accompanied by increasing demand for care and clinical practice will be faced with questions about therapeutic options and the optimal treatment duration for patients with osteoporosis or increased risk of fractures. In this educational article, we are using practical questions to provide an overview of pathophysiology, diagnostics and treatment of osteoporosis and increased risk of fractures.
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August 2020

Serum Matrix Metalloproteinases and Left Atrial Remodeling-The Hoorn Study.

Int J Mol Sci 2020 Jul 13;21(14). Epub 2020 Jul 13.

Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, 6200 MD Maastricht, The Netherlands.

Extracellular matrix protein turnover may play an important role in left atrial (LA) remodelling. The aim is to investigate the associations between matrix metalloproteinase (MMPs), tissue inhibitor of metalloproteinase (TIMP-1) and LA volume index (LAVI) and if these associations are independent of TIMP-1 levels. Participants from The Hoorn Study, a population-based cohort study ( = 674), underwent echocardiography. Serum MMPs (i.e., MMP-1, MMP-2, MMP-3, MMP-9, and MMP-10) and TIMP-1 levels were measured with ELISA. Multiple linear regression analyses were used. MMP-1 levels were not associated with LAVI. Higher MMP-2 levels were associated with larger LAVI (regression coefficient per SD increase in MMP (95% CI); 0.03 (0.01; 0.05). Higher MMP-3 and MMP-9 levels were associated with smaller LAVI; -0.04 (-0.07; -0.01) and -0.04 (-0.06; -0.02) respectively. Only in women were higher MMP-10 levels associated with larger LAVI; 0.04 (0.00; 0.07, -interaction 0.04). Additionally, only in women were higher TIMP-1 levels associated with smaller LAVI; -0.05 (-0.09; -0.01, -interaction 0.03). The associations between MMPs and LAVI were independent of TIMP-1 levels. In conclusion, serum MMPs are associated with LAVI, independent of CVD risk factors and TIMP-1 levels. In addition, these associations differ according to sex and within MMP subgroups. This shows that the role of MMPs in LA remodelling is complex.
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http://dx.doi.org/10.3390/ijms21144944DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404388PMC
July 2020

Metformin and statin use associate with plasma protein -glycosylation in people with type 2 diabetes.

BMJ Open Diabetes Res Care 2020 07;8(1)

Internal Medicine, Erasmus MC, Rotterdam, The Netherlands

Introduction: Recent studies revealed -glycosylation signatures of type 2 diabetes, inflammation and cardiovascular risk factors. Most people with diabetes use medication to reduce cardiovascular risk. The association of these medications with the plasma -glycome is largely unknown. We investigated the associations of metformin, statin, ACE inhibitor/angiotensin II receptor blocker (ARB), sulfonylurea (SU) derivatives and insulin use with the total plasma -glycome in type 2 diabetes.

Research Design And Methods: After enzymatic release from glycoproteins, -glycans were measured by matrix-assisted laser desorption/ionization mass spectrometry in the DiaGene (n=1815) and Hoorn Diabetes Care System (n=1518) cohorts. Multiple linear regression was used to investigate associations with medication, adjusted for clinical characteristics. Results were meta-analyzed and corrected for multiple comparisons.

Results: Metformin and statins were associated with decreased fucosylation and increased galactosylation and sialylation in glycans unrelated to immunoglobulin G. Bisection was increased within diantennary fucosylated non-sialylated glycans, but decreased within diantennary fucosylated sialylated glycans. Only few glycans were associated with ACE inhibitor/ARBs, while none associated with insulin and SU derivative use.

Conclusions: We conclude that metformin and statins associate with a total plasma -glycome signature in type 2 diabetes. Further studies are needed to determine the causality of these relations, and future -glycomic research should consider medication a potential confounder.
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http://dx.doi.org/10.1136/bmjdrc-2020-001230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333804PMC
July 2020

Predicting and elucidating the etiology of fatty liver disease: A machine learning modeling and validation study in the IMI DIRECT cohorts.

PLoS Med 2020 06 19;17(6):e1003149. Epub 2020 Jun 19.

Internal Medicine, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.

Background: Non-alcoholic fatty liver disease (NAFLD) is highly prevalent and causes serious health complications in individuals with and without type 2 diabetes (T2D). Early diagnosis of NAFLD is important, as this can help prevent irreversible damage to the liver and, ultimately, hepatocellular carcinomas. We sought to expand etiological understanding and develop a diagnostic tool for NAFLD using machine learning.

Methods And Findings: We utilized the baseline data from IMI DIRECT, a multicenter prospective cohort study of 3,029 European-ancestry adults recently diagnosed with T2D (n = 795) or at high risk of developing the disease (n = 2,234). Multi-omics (genetic, transcriptomic, proteomic, and metabolomic) and clinical (liver enzymes and other serological biomarkers, anthropometry, measures of beta-cell function, insulin sensitivity, and lifestyle) data comprised the key input variables. The models were trained on MRI-image-derived liver fat content (<5% or ≥5%) available for 1,514 participants. We applied LASSO (least absolute shrinkage and selection operator) to select features from the different layers of omics data and random forest analysis to develop the models. The prediction models included clinical and omics variables separately or in combination. A model including all omics and clinical variables yielded a cross-validated receiver operating characteristic area under the curve (ROCAUC) of 0.84 (95% CI 0.82, 0.86; p < 0.001), which compared with a ROCAUC of 0.82 (95% CI 0.81, 0.83; p < 0.001) for a model including 9 clinically accessible variables. The IMI DIRECT prediction models outperformed existing noninvasive NAFLD prediction tools. One limitation is that these analyses were performed in adults of European ancestry residing in northern Europe, and it is unknown how well these findings will translate to people of other ancestries and exposed to environmental risk factors that differ from those of the present cohort. Another key limitation of this study is that the prediction was done on a binary outcome of liver fat quantity (<5% or ≥5%) rather than a continuous one.

Conclusions: In this study, we developed several models with different combinations of clinical and omics data and identified biological features that appear to be associated with liver fat accumulation. In general, the clinical variables showed better prediction ability than the complex omics variables. However, the combination of omics and clinical variables yielded the highest accuracy. We have incorporated the developed clinical models into a web interface (see: https://www.predictliverfat.org/) and made it available to the community.

Trial Registration: ClinicalTrials.gov NCT03814915.
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http://dx.doi.org/10.1371/journal.pmed.1003149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304567PMC
June 2020

Phenotypic and lifestyle determinants of HbA1c in the general population-The Hoorn Study.

PLoS One 2020 4;15(6):e0233769. Epub 2020 Jun 4.

Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Aim: To investigate the relative contribution of phenotypic and lifestyle factors to HbA1c, independent of fasting plasma glucose (FPG) and 2h post-load glucose (2hPG), in the general population.

Methods: The study populations included 2309 participants without known diabetes from the first wave of the Hoorn Study (1989) and 2619 from the second wave (2006). Multivariate linear regression models were used to analyze the relationship between potential determinants and HbA1c in addition to FPG and 2hPG. The multivariate model was derived in the first wave of the Hoorn Study, and replicated in the second wave.

Results: In both cohorts, independent of FPG and 2hPG, higher age, female sex, larger waist circumference, and smoking were associated with a higher HbA1c level. Larger hip circumference, higher BMI, higher alcohol consumption and vitamin C intake were associated with a lower HbA1c level. FPG and 2hPG together explained 41.0% (first wave) and 53.0% (second wave) of the total variance in HbA1c. The combination of phenotypic and lifestyle determinants additionally explained 5.7% (first wave) and 3.9% (second wave).

Conclusions: This study suggests that, independent of glucose, phenotypic and lifestyle factors are associated with HbA1c, but the contribution is relatively small. These findings contribute to a better understanding of the low correlation between glucose levels and HbA1c in the general population.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233769PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272077PMC
August 2020

Prediction models for development of retinopathy in people with type 2 diabetes: systematic review and external validation in a Dutch primary care setting.

Diabetologia 2020 06 3;63(6):1110-1119. Epub 2020 Apr 3.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

Aims/hypothesis: The aims of this study were to identify all published prognostic models predicting retinopathy risk applicable to people with type 2 diabetes, to assess their quality and accuracy, and to validate their predictive accuracy in a head-to-head comparison using an independent type 2 diabetes cohort.

Methods: A systematic search was performed in PubMed and Embase in December 2019. Studies that met the following criteria were included: (1) the model was applicable in type 2 diabetes; (2) the outcome was retinopathy; and (3) follow-up was more than 1 year. Screening, data extraction (using the checklist for critical appraisal and data extraction for systemic reviews of prediction modelling studies [CHARMS]) and risk of bias assessment (by prediction model risk of bias assessment tool [PROBAST]) were performed independently by two reviewers. Selected models were externally validated in the large Hoorn Diabetes Care System (DCS) cohort in the Netherlands. Retinopathy risk was calculated using baseline data and compared with retinopathy incidence over 5 years. Calibration after intercept adjustment and discrimination (Harrell's C statistic) were assessed.

Results: Twelve studies were included in the systematic review, reporting on 16 models. Outcomes ranged from referable retinopathy to blindness. Discrimination was reported in seven studies with C statistics ranging from 0.55 (95% CI 0.54, 0.56) to 0.84 (95% CI 0.78, 0.88). Five studies reported on calibration. Eight models could be compared head-to-head in the DCS cohort (N = 10,715). Most of the models underestimated retinopathy risk. Validating the models against different severities of retinopathy, C statistics ranged from 0.51 (95% CI 0.49, 0.53) to 0.89 (95% CI 0.88, 0.91).

Conclusions/interpretation: Several prognostic models can accurately predict retinopathy risk in a population-based type 2 diabetes cohort. Most of the models include easy-to-measure predictors enhancing their applicability. Tailoring retinopathy screening frequency based on accurate risk predictions may increase the efficiency and cost-effectiveness of diabetic retinopathy care.

Registration: PROSPERO registration ID CRD42018089122.
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http://dx.doi.org/10.1007/s00125-020-05134-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7228897PMC
June 2020

High prevalence of impaired awareness of hypoglycemia and severe hypoglycemia among people with insulin-treated type 2 diabetes: The Dutch Diabetes Pearl Cohort.

BMJ Open Diabetes Res Care 2020 02;8(1)

Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.

Objective: People with type 2 diabetes on insulin are at risk for hypoglycemia. Recurrent hypoglycemia can cause impaired awareness of hypoglycemia (IAH), and increase the risk for severe hypoglycemia. The aim of this study was to assess the prevalence and determinants of self-reported IAH and severe hypoglycemia in a Dutch nationwide cohort of people with insulin-treated type 2 diabetes.

Research Design And Methods: Observational study of The Dutch Diabetes Pearl, a cohort of people with type 2 diabetes treated in primary, secondary and tertiary diabetes care centers. The presence of IAH and the occurrence of severe hypoglycemia in the past year, defined as an event requiring external help to recover, were assessed using the validated Dutch version of the Clarke questionnaire. In addition, clinical variables were collected including age, diabetes duration, hemoglobin A1c, ethnicity and education.

Results: 2350 people with type 2 diabetes on insulin were included: 59.1% men, mean age 61.1±10.4 years, mean diabetes duration 14.8±9.2 years and 79.5% on basal-bolus therapy. A total of 229 patients (9.7%) were classified as having IAH and 742 patients (31.6%) reported severe hypoglycemia. Increased odds for IAH were found with complex insulin regimens and lower odds with having a partner and body mass index ≥30 kg/m. Severe hypoglycemia was associated with complex insulin regimens, non-Caucasian ethnicity and use of psychoactive drugs, and inversely with metformin use.

Conclusions: In this nationwide cohort, almost one out of ten people with type 2 diabetes on insulin had IAH and >30% had a history of severe hypoglycemia in the past year.
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http://dx.doi.org/10.1136/bmjdrc-2019-000935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206921PMC
February 2020

Integration of epidemiologic, pharmacologic, genetic and gut microbiome data in a drug-metabolite atlas.

Nat Med 2020 01 13;26(1):110-117. Epub 2020 Jan 13.

Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Progress in high-throughput metabolic profiling provides unprecedented opportunities to obtain insights into the effects of drugs on human metabolism. The Biobanking BioMolecular Research Infrastructure of the Netherlands has constructed an atlas of drug-metabolite associations for 87 commonly prescribed drugs and 150 clinically relevant plasma-based metabolites assessed by proton nuclear magnetic resonance. The atlas includes a meta-analysis of ten cohorts (18,873 persons) and uncovers 1,071 drug-metabolite associations after evaluation of confounders including co-treatment. We show that the effect estimates of statins on metabolites from the cross-sectional study are comparable to those from intervention and genetic observational studies. Further data integration links proton pump inhibitors to circulating metabolites, liver function, hepatic steatosis and the gut microbiome. Our atlas provides a tool for targeted experimental pharmaceutical research and clinical trials to improve drug efficacy, safety and repurposing. We provide a web-based resource for visualization of the atlas (http://bbmri.researchlumc.nl/atlas/).
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http://dx.doi.org/10.1038/s41591-019-0722-xDOI Listing
January 2020

Visit-to-visit variability of glycemia and vascular complications: the Hoorn Diabetes Care System cohort.

Cardiovasc Diabetol 2019 12 12;18(1):170. Epub 2019 Dec 12.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Institute, Amsterdam UMC, Location VUMC, De Boelelaan 1089a, 1081 HV, Amsterdam, The Netherlands.

Background: Glycemic variation has been suggested to be a risk factor for diabetes-related complications. Previous studies did not address confounding of diabetes duration, number of visits and length of follow-up. Here, we characterize glycemic variability over time and whether its relation to diabetes-related complications and mortality is independent from diabetes- and follow-up duration.

Materials And Methods: Individuals with type 2 diabetes (n = 6770) from the Hoorn Diabetes Care System cohort were included in this study. The coefficient of variation (CV) was calculated over 5-year sliding intervals. People divided in quintiles based on their CV. Cox proportional hazard models were used to investigate the role of glycemic CV as risk factor in diabetes-related complications and mortality.

Results: The coefficient of variation of glucose (FG-CV) increased with time, in contrast to HbA1c (HbA1c-CV). People with a high FG-CV were those with an early age of diabetes onset (Δ = - 2.39 years), a higher BMI (Δ = + 0.92 kg/m), an unfavorable lipid profile, i.e. lower levels of HDL-C (Δ = - 0.06 mmol/mol) and higher triglycerides (Δ =+ 1.20 mmol/mol). People with the highest FG-CV in the first 5-year interval showed an increased risk of insulin initiation, retinopathy, macrovascular complications and mortality independent of mean glycemia, classical risk factors and medication use. For HbA1c, the associations were weaker and less consistent.

Conclusions: Individuals with a higher FG-CV have an unfavorable metabolic profile and have an increased risk of developing micro- and macrovascular complications and mortality. The association of HbA1c-CV with metabolic outcomes and complications was less consistent in comparison to FG-CV.
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http://dx.doi.org/10.1186/s12933-019-0975-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909524PMC
December 2019

Effectiveness and cost-utility of a multifaceted eHealth strategy to improve back pain beliefs of patients with non-specific low back pain: a cluster randomised trial.

BMJ Open 2019 12 5;9(12):e030879. Epub 2019 Dec 5.

Department of Public and Occupational Health, Amsterdam UMC - Locatie VUMC, Amsterdam, The Netherlands.

Objectives: To assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism.

Design: Stepped-wedge cluster randomised trial with parallel economic evaluation.

Setting: Dutch primary healthcare.

Participants: Patients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).

Interventions: The intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.

Primary And Secondary Outcome Measures: The primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.

Results: There were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70- and the societal cost difference was €535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).

Conclusions: A multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.

Trial Registration Number: NTR4329.
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http://dx.doi.org/10.1136/bmjopen-2019-030879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924789PMC
December 2019

Sleep and HbA in Patients With Type 2 Diabetes: Which Sleep Characteristics Matter Most?

Diabetes Care 2020 01 12;43(1):235-243. Epub 2019 Nov 12.

Department of Psychiatry, Amsterdam UMC, Vrije Universiteit, and GGZ inGeest, Amsterdam Public Health research institute, Amsterdam, the Netherlands.

Objective: Poor sleep has been identified as a risk factor for poor glycemic control in individuals with type 2 diabetes (T2D). As optimal sleep can be characterized in several ways, we evaluated which sleep characteristics are most strongly associated with glycated hemoglobin A (HbA).

Research Design And Methods: A total of 172 patients with T2D completed 7-day wrist-actigraphy and sleep questionnaires. Linear regression was used to evaluate associations between sleep measures (total sleep duration, variability in sleep duration, midsleep time, variability in midsleep time, sleep efficiency, subjective sleep quality, and subjective insomnia symptoms) and HbA, individually and in concert.

Results: Variability in sleep duration was individually most strongly associated with HbA (β = 0.239; = 0.002; = 4.9%), followed by total sleep duration (U-shaped: β = 1.161/β = 1.044; = 0.017/0.032; = 4.3%), subjective sleep quality (β = 0.191; = 0.012; = 3.6%), variability in midsleep time (β = 0.184; = 0.016; = 3.4%), and sleep efficiency (β = -0.150; = 2.3%). Midsleep time and subjective insomnia symptoms were not associated with HbA. In combination, variability in sleep duration, total sleep duration, and subjective sleep quality were significantly associated with HbA, together explaining 10.3% of the variance in HbA. Analyses adjusted for covariates provided similar results, although the strength of associations was generally decreased and showing total sleep duration and subjective sleep quality to be most strongly associated with HbA, together explaining 6.0% of the variance in HbA.

Conclusions: Sleep in general may be a modifiable factor of importance for patients with T2D. The prevention of sleep curtailment may serve as a primary focus in the sleep-centered management of T2D.
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http://dx.doi.org/10.2337/dc19-0550DOI Listing
January 2020

Moderate and heavy alcohol consumption are prospectively associated with decreased left ventricular ejection fraction: The Hoorn Study.

Nutr Metab Cardiovasc Dis 2020 01 30;30(1):132-140. Epub 2019 Sep 30.

Department of Epidemiology and Biostatistics, Amsterdam Cardiovascular Sciences Research Institute, Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands; Department of Nephrology, Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.

Background And Aims: Data on the prospective relationship of alcohol consumption at more moderate levels with systolic and diastolic function are scarce. We aimed to examine the prospective association of alcohol consumption with echocardiographic measures of cardiac structure and function, in individuals with and without type 2 diabetes (T2DM).

Methods And Results: We included 778 participants from the Hoorn Study (aged 68.4 ± 7.2 years, 49% women), a population-based prospective cohort study, oversampled for people with impaired glucose metabolism or T2DM. Self-reported alcohol consumption was collected at baseline with a validated food-frequency questionnaire and categorized into: none (0/week), light (>0-≤30 g/week), light-to-moderate (>30-≤70 g/week), moderate (>70-≤140 g/week), and heavy drinkers (>140 g/week). Echocardiography was performed at baseline (N = 778) and after 8 years follow-up (N = 404). Multiple linear regression was used to study the association between alcohol consumption and echocardiographic measures (left ventricular ejection fraction (LVEF), left atrial volume index (LAVI) and left ventricular mass index (LVMI)), adjusted for confounders. Moderate and heavy alcohol consumption were associated with a decreased LVEF of -3.91% (CI: -7.13;-0.69) for moderate and -4.77% (-8.18;-1.36) for heavy drinkers compared to light drinkers. No associations were found between alcohol consumption, LVMI and LAVI. Modified Poisson regression showed a trend that higher alcohol consumption amounts were associated with a higher risk of incident systolic dysfunction (LVEF≤50%) (P-for-trend 0.058).

Conclusion: The findings provide longitudinal evidence that moderate and heavy alcohol consumption are associated with decreased LVEF and trend towards a higher risk of incident LV systolic dysfunction, compared to light drinkers.
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http://dx.doi.org/10.1016/j.numecd.2019.09.021DOI Listing
January 2020

Vitamin D supplementation for the prevention of depression and poor physical function in older persons: the D-Vitaal study, a randomized clinical trial.

Am J Clin Nutr 2019 11;110(5):1119-1130

Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

Background: Depressive symptoms and impaired physical functioning are prevalent among older adults. Supplementation with vitamin D might improve both conditions, particularly in persons with low vitamin D status.

Objective: The D-Vitaal study primarily aimed to investigate the effect of vitamin D supplementation on depressive symptoms, functional limitations, and physical performance in a high-risk older population with low vitamin D status. Secondary aims included examining the effect of vitamin D supplementation on anxiety symptoms, cognitive functioning, mobility, handgrip strength, and health-related quality of life.

Methods: This study was a randomized placebo-controlled trial with 155 participants aged 60-80 y who had clinically relevant depressive symptoms, ≥1 functional limitations, and serum 25-hydroxyvitamin D [25(OH)D] concentrations of 15-50/70 nmol/L (depending on season). Participants received 1200 IU/d vitamin D3 (n = 77) or placebo tablets (n = 78) for 12 mo. Serum 25(OH)D was measured at baseline and 6 mo; outcomes were assessed at baseline, 6 mo, and 12 mo. Linear mixed-models analyses were conducted to assess the effect of the intervention.

Results: The supplementation increased serum 25(OH)D concentrations in the intervention group to a mean ± SD of 85 ± 16 nmol/L compared with 43 ± 18 nmol/L in the placebo group after 6 mo (P < 0.001). No relevant differences between the treatment groups were observed regarding depressive symptoms, functional limitations, physical performance, or any of the secondary outcomes.

Conclusions: Supplementation with 1200 IU/d vitamin D for 12 mo had no effect on depressive symptoms and physical functioning in older persons with relatively low vitamin D status, clinically relevant depressive symptoms, and poor physical functioning. This trial is registered with the Netherlands Trial Register (www.trialregister.nl) under NTR3845.
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http://dx.doi.org/10.1093/ajcn/nqz141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821546PMC
November 2019

Implementation fidelity of an intervention programme to enhance adherence to antihypertensive medication in Dutch community pharmacies.

Int J Clin Pharm 2019 Aug 15;41(4):1031-1046. Epub 2019 May 15.

Department of Clinical Pharmacology and Pharmacy, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.

Background Insight into the delivery of interventions is necessary to gain a better understanding of what caused an intervention to succeed or fail. The Cardiovascular medication non-Adherence Tailored Intervention (CATI) study failed to show effectiveness of a patient-tailored, pharmacist-led intervention programme on self-reported adherence to antihypertensive medication. Objective To evaluate the implementation fidelity of the CATI intervention programme. Setting Twenty Dutch community pharmacies. Method The process of a randomised controlled trial was evaluated. Both quantitative and qualitative data were collected and analysed according to Carrolls' Conceptual Framework for Implementation Fidelity. Implementation fidelity is defined as the degree to which the intervention was implemented as intended. Main outcome measure Four key intervention components of the intervention programme (i.e., first consultation: barrier identification, information and advice, written summary, and follow-up consultation). Results For most participants the key intervention components were implemented as intended. The training of pharmacists, intensive monitoring during the study and structured and easy-to-use intervention materials facilitated the implementation of the intervention. The method to select participants for the intervention programme was considered insufficient and pharmacists questioned the eligibility of some participants because of a low degree of intake non-adherence. Conclusion Implementation fidelity was moderate to high for all key intervention components. Therefore, the absence of effectiveness of the CATI intervention programme on self-reported medication adherence cannot be explained by poor implementation of the intervention. However, the limited genuine eligibility of some participants resulted in a limited potential for improvement in medication adherence.
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http://dx.doi.org/10.1007/s11096-019-00845-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677874PMC
August 2019

Neighbourhood characteristics and prevalence and severity of depression: pooled analysis of eight Dutch cohort studies.

Br J Psychiatry 2019 08 6;215(2):468-475. Epub 2019 May 6.

Professor,Amsterdam UMC, Vrije Universiteit Amsterdam,Department of Psychiatry,Amsterdam Public Health; andGGZ inGeest Specialized Mental Health Care, Research and Innovation, the Netherlands.

Background: Studies on neighbourhood characteristics and depression show equivocal results.AimsThis large-scale pooled analysis examines whether urbanisation, socioeconomic, physical and social neighbourhood characteristics are associated with the prevalence and severity of depression.

Method: Cross-sectional design including data are from eight Dutch cohort studies (n = 32 487). Prevalence of depression, either DSM-IV diagnosis of depressive disorder or scoring for moderately severe depression on symptom scales, and continuous depression severity scores were analysed. Neighbourhood characteristics were linked using postal codes and included (a) urbanisation grade, (b) socioeconomic characteristics: socioeconomic status, home value, social security beneficiaries and non-Dutch ancestry, (c) physical characteristics: air pollution, traffic noise and availability of green space and water, and (d) social characteristics: social cohesion and safety. Multilevel regression analyses were adjusted for the individual's age, gender, educational level and income. Cohort-specific estimates were pooled using random-effects analysis.

Results: The pooled analysis showed that higher urbanisation grade (odds ratio (OR) = 1.05, 95% CI 1.01-1.10), lower socioeconomic status (OR = 0.90, 95% CI 0.87-0.95), higher number of social security beneficiaries (OR = 1.12, 95% CI 1.06-1.19), higher percentage of non-Dutch residents (OR = 1.08, 95% CI 1.02-1.14), higher levels of air pollution (OR = 1.07, 95% CI 1.01-1.12), less green space (OR = 0.94, 95% CI 0.88-0.99) and less social safety (OR = 0.92, 95% CI 0.88-0.97) were associated with higher prevalence of depression. All four socioeconomic neighbourhood characteristics and social safety were also consistently associated with continuous depression severity scores.

Conclusions: This large-scale pooled analysis across eight Dutch cohort studies shows that urbanisation and various socioeconomic, physical and social neighbourhood characteristics are associated with depression, indicating that a wide range of environmental aspects may relate to poor mental health.Declaration of interestNone.
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http://dx.doi.org/10.1192/bjp.2019.100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7872255PMC
August 2019
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