Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial

Autor: Adrie J.M. Verhoeven, Monique T. Mulder, Hans E. van der Wiel, M. Rashid, Athumani A. Athumani, Eric J.G. Sijbrands, Yvonne van Beek-Nieuwland, Reinier Timman, Kirsten A. Berk, Adrienne A.M. Zandbergen
Přispěvatelé: Internal Medicine, Psychiatry
Rok vydání: 2018
Předmět:
endocrine system diseases
Flavonols
Medicine (miscellaneous)
030204 cardiovascular system & hematology
Gastroenterology
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Outcome Assessment
Health Care
Clinical endpoint
Multicenter Studies as Topic
Pharmacology (medical)
Vitis
Randomized Controlled Trials as Topic
Aged
80 and over
lcsh:R5-920
biology
Middle Aged
Data Interpretation
Statistical
Seeds
lcsh:Medicine (General)
Adult
medicine.medical_specialty
030209 endocrinology & metabolism
Placebo
03 medical and health sciences
Monomeric flavanols
Von Willebrand factor
Double-Blind Method
SDG 3 - Good Health and Well-being
Internal medicine
Multicenter trial
Type 2 diabetes mellitus
medicine
Albuminuria
Humans
Aged
business.industry
Dietary management
nutritional and metabolic diseases
Type 2 Diabetes Mellitus
medicine.disease
Diabetes Mellitus
Type 2
Oligomeric flavanols
Sample Size
biology.protein
Microalbuminuria
business
Zdroj: Trials, 19:379. BioMed Central Ltd.
Trials
Trials, Vol 19, Iss 1, Pp 1-9 (2018)
ISSN: 1745-6215
Popis: Background Patients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications. Monomeric and oligomeric flavanols (MOF) isolated from grape seeds (Vitis vinifera) have been linked to improved endothelial function and vascular health. The aim of this study is to determine the effect of a daily supplementation of 200 mg MOF on renal endothelial function of patients with T2D and microalbuminuria. Methods/design For this double-blind, placebo-controlled, randomized, multicenter trial 96 individuals (ages 40–85 years) with T2D and microalbuminuria will be recruited. Participants will be randomly assigned to the intervention group, receiving 200 mg of MOF daily for 3 months, or to the control group, receiving a placebo. The primary endpoint is the evolution over time in albumin excretion rate (AER) until 3 months of intervention as compared with placebo. Secondary endpoints are the evolution over time in established plasma markers of renal endothelial function—asymmetric dimethylarginine (ADMA), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intercellular cell adhesion molecule-1 (sICAM-1), interleukin-6 (IL-6), and von Willebrand Factor (vWF)—until 3 months of intervention as compared with placebo. Mixed modeling will be applied for the statistical analysis of the data. Discussion We hypothesize that T2D patients with microalbuminuria have a medically determined requirement for MOF and that fulfilling this requirement will result in a decrease in AER and related endothelial biomarkers. If confirmed, this may lead to new insights in the dietary management of patients with T2D. Trial registration Nederlands Trial Register, NTR4669, registered on 7 July 2014. Electronic supplementary material The online version of this article (10.1186/s13063-018-2762-9) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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