دورية أكاديمية
The effect of monomeric and oligomeric FLAVAnols in patients with type 2 diabetes and microalbuminuria (FLAVA-trial): A double-blind randomized controlled trial.
| العنوان: | The effect of monomeric and oligomeric FLAVAnols in patients with type 2 diabetes and microalbuminuria (FLAVA-trial): A double-blind randomized controlled trial. |
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| المؤلفون: | Rashid M; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands., Verhoeven AJM; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands., Mulder MT; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands., Timman R; Department of Psychiatry, Section of Medical Psychology and Psychotherapy, Erasmus University Medical Center, Rotterdam, the Netherlands., Ozcan B; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands., van Beek-Nieuwland Y; Department of Internal Medicine, Havenziekenhuis, Rotterdam, the Netherlands., Chow LM; General Practitioners Group, Gezondheidscentrum Zuidplein, Rotterdam, the Netherlands., van de Laar RJJM; Department of Internal Medicine, Ikazia Ziekenhuis, Rotterdam, the Netherlands., Dik WA; Department of Immunology, Laboratory of Medical Immunology, Department of Internal Medicine, Division of Clinical Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands., Sijbrands EJG; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands., Berk KA; Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Internal Medicine, Division of Dietetics, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: k.berk@erasmusmc.nl. |
| المصدر: | Clinical nutrition (Edinburgh, Scotland) [Clin Nutr] 2021 Nov; Vol. 40 (11), pp. 5587-5594. Date of Electronic Publication: 2021 Sep 24. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 8309603 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1983 (Electronic) Linking ISSN: 02615614 NLM ISO Abbreviation: Clin Nutr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2004->: Kidlington, Oxford, U.K. : Elsevier Original Publication: Edinburgh ; New York : Churchill Livingstone, c1982- |
| مواضيع طبية MeSH: | Dietary Supplements*, Albuminuria/*therapy , Diabetes Mellitus, Type 2/*therapy , Endothelium, Vascular/*drug effects , Flavonols/*administration & dosage, Aged ; Albuminuria/complications ; Albuminuria/physiopathology ; Biomarkers/blood ; Biomarkers/urine ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/physiopathology ; Double-Blind Method ; Female ; Flavonols/chemistry ; Humans ; Male ; Middle Aged ; Treatment Outcome |
| مستخلص: | Background & Aims: Microalbuminuria is an early sign of vascular complications of type 2 diabetes and predicts cardiovascular disease and mortality. Monomeric and oligomeric flavanols (MOFs) are linked to improved vascular health. The aim of this study was to assess the effect of 3 months MOFs on albuminuria and endothelial function markers in patients with type 2 diabetes and microalbuminuria. Methods: We conducted a double-blind, placebo-controlled trial among patients with type 2 diabetes and microalbuminuria. Patients with type 2 diabetes received either 200 mg MOFs or placebo daily on top of their habitual diet and medication. The primary endpoint was the between-group difference of the change in 24-h Albumin Excretion Rate (AER) over three months. Secondary endpoints were the between-group differences of the change in plasma levels of different markers of endothelial dysfunction. Mixed-modelling was applied for the longitudinal analyses. Results: Participants (n = 97) were 63.0 ± 9.5 years old; diabetes-duration was 15.7 ± 8.5 years. Median baseline AER was 60 (IQR 20-120) mg/24 h. There was no within-group difference in median change of AER from baseline to 3 months in the intervention (0 (-35-21) mg/24 h, p = 0.41) or the control group (0 (-20-10) mg/24 h, p = 0.91). There was no between-group difference in the course of AER over three months (log-transformed data: β = -0.02 (95%CI -0.23-0.20), p = 0.88), nor in the plasma levels of the endothelial dysfunction markers. Conclusion: Daily 200 mg MOFs for three months on top of habitual diet and usual care did not reduce AER and plasma markers of endothelial dysfunction compared to placebo, in patients with long-term type 2 diabetes and microalbuminuria. Clinical Trials Registration: NTR4669, www.trialregister.nl. (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Endothelial cell markers; Flavanols; Microalbuminuria; Type 2 diabetes |
| سلسلة جزيئية: | NTR NTR4669 |
| المشرفين على المادة: | 0 (Biomarkers) 0 (Flavonols) |
| تواريخ الأحداث: | Date Created: 20211017 Date Completed: 20220126 Latest Revision: 20220126 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.clnu.2021.09.038 |
| PMID: | 34656955 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1532-1983 |
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| DOI: | 10.1016/j.clnu.2021.09.038 |