Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active First<br>Active resveratrol first, placebo second | Dietary Supplement: Resveratrol<br>* Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.<br>Dietary Supplement: Placebo<br>* Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.<br>|
| Experimental: Placebo first<br>Placebo first, active resveratrol second | Dietary Supplement: Resveratrol<br>* Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.<br>Dietary Supplement: Placebo<br>* Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Brachial artery flow mediated dilation |  | 2 hours, 2 weeks, and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fingertip peripheral arterial tonometry |  | 2 hours, 2 weeks, and 4 weeks | 
| Change from Baseline in Carotid femoral pulse wave velocity |  | 4 weeks | 
| Change from Baseline in Reactive hyperemia |  | 2 hours, 2 weeks, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide