Pilot Study Of The Effects Of Resveratrol On Endothelial Function In Subjects With Type 2 Diabetes Mellitus

Observational studies have shown that consumption of grapes and grape products such as red wine is associated with reduced cardiovascular risk. The mechanisms accounting for this benefit remain incompletely understood. Resveratrol is a component of grapes and red wine that has favorable effects on endothelial function in diabetic and obese animals. Resveratrol is available to people over-the-counter in health food stores and the internet as a dietary supplement.

The endothelium plays a central role in the control of blood vessel function. When healthy, the endothelium prevents vasospasm, blood clot formation, and the development of atherosclerosis. Endothelial function is abnormal in patients with diabetes mellitus and this abnormality contributes to the development of cardiovascular disease.

The present pilot study is designed to test the hypothesis that resveratrol (90 mg/day and 270 mg/day for one week each) will have favorable effects on endothelial function in patients with diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Resveratrol

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and Female subjects.
2. Age over 21 years old.
3. Body mass index greater than or equal to 25 and less than 35 kg/m2
4. Clinically stable Type 2 diabetes mellitus.
5. Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
6. Willing to refrain from consumption of red wine, grape juice, and grape products beginning two weeks before and continuing throughout the entire study period.

Exclusion Criteria:

1. Women who lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
2. Treatment with an investigational product within the last 30 days.
3. Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
4. Liver transaminase levels greater than 3X the upper limit of normal.
5. History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
6. Vitamin supplements exceeding two times the recommending daily allowance (RDA) within the last 30 days prior to screening.
7. Resveratrol, green tea and isoflavone supplements within the last 30 days prior to screening.
8. Subjects who practice a vegetarian or vegan diet
9. Subjects taking budesonide, buspirone, eplerenone, eletriptan, felodipine, midazolam, saquinavir, sildenafil, triazolam, vardenafil, alfentanil, astemizole, cisapride, cyclosporine, diergotamine, ergotamine, fentanyl, irinotecan, pimozide, quinidine, sirolimus, tacrolimus, terfenadine, or warfarin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: resveratrol; Resveratrol	Dietary supplement: Resveratrol; Resveratrol; Other Names: ResVida

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Brachial artery flow-mediated dilation	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood markers of inflammation, oxidative stress, insulin resistance	2 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: DSM Nutritional Products, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 19, 2009
• First Submitted That Met QC Criteria: December 21, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 21, 2010
• Last Update Submitted That Met QC Criteria: December 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: diabetes mellitus; resveratrol; endothelium
• 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-28258