Abstract
BackgroundPatients 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/designFor 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.DiscussionWe 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 registrationNederlands Trial Register, NTR4669, registered on 7 July 2014.
Highlights
Patients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications
We hypothesize that T2D patients with microalbuminuria have a medically determined requirement for Monomeric and oligomeric flavanols (MOF) and that fulfilling this requirement will result in a decrease in albumin excretion rate (AER) and related endothelial biomarkers
Other established biomarkers for endothelial function are asymmetric dimethylarginine (ADMA), soluble vascular cell adhesion molecule 1, interleukin-6 (IL-6), von Willebrand Factor, and soluble intercellular cell adhesion molecule 1, all of which have been related to renal endothelial health and vascular complications in T2D [7]
Summary
The presence of microalbuminuria is associated with endothelial dysfunction and poor cardiovascular outcome in T2D [31]. We hypothesize that the use of 200 mg MOF daily for 3 months will have a beneficial effect on renal endothelial function and will result in a decrease of AER This may lead to new insights into the dietary management of T2D patients with renal complications. Since the participants in this trial are recruited from tertiary, secondary, and primary referral centers, our study sample well represents T2D patients with microalbuminuria in general. Trial sponsor: Erasmus Medical Center, Rotterdam, The Netherlands. Author details 1Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands. Author details 1Department of Internal Medicine, Section of Pharmacology, Vascular and Metabolic Diseases, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands. 2Department of Dietetics, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands. 3Department of Psychiatry, Section of Medical Psychology and Psychotherapy, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands. 4Department of Internal Medicine, Havenziekenhuis, Haringvliet 2, Rotterdam 3011 TD, The Netherlands. 5General Practitioners Group, Stichting Zorg op Zuid, Maashaven Oostzijde 155, Rotterdam 3072 HS, The Netherlands. 6Department of Internal Medicine, Ikazia Ziekenhuis, Montessoriweg 1, Rotterdam 3083 HN, The Netherlands. 7Department of Internal Medicine, IJsselland Ziekenhuis, Prins Constantijnweg 2, Capelle aan de Ijssel 2906 ZC, The Netherlands
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