Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Resveratrol; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (ESTIMATE): June 19, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: mitochondria; nitric oxide; arterial stiffness; vascular biology; endothelium; reactive oxygen species
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: H-32036; 5P01HL068758-10 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No