Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT01881347

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Dietary Supplement: Resveratrol Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active First Active resveratrol first, placebo second	Dietary Supplement: Resveratrol Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks. Dietary Supplement: Placebo Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
Experimental: Placebo first Placebo first, active resveratrol second	Dietary Supplement: Resveratrol Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks. Dietary Supplement: Placebo Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.

Arm

Intervention/Treatment

Experimental: Active First

Active resveratrol first, placebo second

Dietary Supplement: Resveratrol

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

Dietary Supplement: Placebo

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

Experimental: Placebo first

Placebo first, active resveratrol second

Dietary Supplement: Resveratrol

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

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

Change from baseline in Brachial artery flow mediated dilation [2 hours, 2 weeks, and 4 weeks]

Secondary Outcome Measures

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]

Other Outcome Measures

Change from Baseline in Serum glucose [2 and 4 weeks]
Change from Baseline in Serum insulin [2 and 4 weeks]
Change from Baseline in Mononuclear cell mitochondrial DNA damage [4 weejs]
Change from Baseline in Mononuclear cell mitochondrial mass [4 weeks]
Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species [4 weeks]
Change from Baseline in Endothelial cell gene expression [4 weeks]
Change from Baseline in Endothelial cell protein expression [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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