Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Boston University54 enrolled

Overview

The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus. The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

ResveratrolDIETARY_SUPPLEMENT

Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

PlaceboDIETARY_SUPPLEMENT

Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects * Age over 21 years old * Body mass index less than 38 kg/m2 * Clinical stable type 2 diabetes mellitus Exclusion Criteria: * Women who are lactating or pregnant * Treatment with an investigations product within 30 days of screening * Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate * Liver transaminase levels greater than 3 times the upper limit of normal * History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study * Vitamin supplements exceeding two times the recommended daily allowance * Resveratrol or other dietary supplements except for a daily multivitamin

Locations (1)

Boston University Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change from baseline in Brachial artery flow mediated dilation

Time frame: 2 hours, 2 weeks, and 4 weeks

Secondary Outcomes

Change from Baseline in Fingertip peripheral arterial tonometry

Time frame: 2 hours, 2 weeks, and 4 weeks

Change from Baseline in Carotid femoral pulse wave velocity

Time frame: 4 weeks

Change from Baseline in Reactive hyperemia

Time frame: 2 hours, 2 weeks, 4 weeks

Data from ClinicalTrials.gov

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