Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Boston University1 site in 1 country54 target enrollmentJanuary 1, 2013

ConditionsDiabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Boston University
Enrollment: 54
Locations: 1
Primary Endpoint: Change from baseline in Brachial artery flow mediated dilation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

July 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boston University

Responsible Party

Sponsor

Eligibility Criteria

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

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 Carotid femoral pulse wave velocity(4 weeks)
Change from Baseline in Reactive hyperemia(2 hours, 2 weeks, 4 weeks)
Change from Baseline in Fingertip peripheral arterial tonometry(2 hours, 2 weeks, and 4 weeks)