Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

• Registration Number: NCT01881347
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2015-03-01
• Study Completion: 2016-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active First	Resveratrol	Active resveratrol first, placebo second
Active First	Placebo	Active resveratrol first, placebo second
Placebo first	Resveratrol	Placebo first, active resveratrol second
Placebo first	Placebo	Placebo first, active resveratrol second

Primary Outcome Measures

Name	Time	Method
Change from baseline in Brachial artery flow mediated dilation	2 hours, 2 weeks, and 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States