Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Boston University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01881347

H-32036

5P01HL068758-10 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Active First

Experimental group

Description:

Active resveratrol first, placebo second

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Resveratrol

Placebo first

Experimental group

Description:

Placebo first, active resveratrol second

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Resveratrol