Resveratrol and Vascular Function in CKD

Not Applicable

Completed

Conditions: Chronic Kidney Diseases
Endothelial Dysfunction

Interventions: Dietary Supplement: Resveratrol
Other: Placebo

Registration Number: NCT03597568

Lead Sponsor: Diana Jalal

Brief Summary: The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.

Detailed Description: Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction in CKD are a priority.

Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)

The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
Able to give informed consent
Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
Type II diabetes mellitus

Exclusion Criteria

Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
Life expectancy <1 year
BMI >40 kg/m2 1
Pregnant, breastfeeding, or unwilling to use adequate birth control
Uncontrolled hypertension; blood pressure > 140/90
Uncontrolled type II DM; AIC > 8.5
Currently taking anticoagulants including: coumadin, dalteparin, enoxaparin, haparin, and plavix.
Severe liver disease
Severe systolic heart failure
Hospitalization within the last 3 months
Active infection or antibiotic therapy
Immunosuppressive therapy within the last year
Currently partaking in another research study

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening
Placebo	Placebo	Patients will receive placebo pill identical in appearance and taste to the supplement

Primary Outcome Measures

Name	Time	Method
% Change of Brachial Artery Flow-mediated Dilation	First Baseline measurement to 6 weeks then Second baseline to 6 weeks	Brachial artery flow-mediated dilation, dilation of the brachial artery in response to shear stress. Resveratrol first, then placebo: Baseline to 6 weeks on Resveratrol Minimum 2 week washout Baseline to 6 week on placebo Placebo first, then resveratrol: Baseline to 6 weeks on placebo Minimum washout 2 weeks Baseline to 6 weeks on resveratrol