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

NCT01038089 | Completed

• 1 other identifier: H-28258
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

endothelium; resveratrol; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Brachial artery flow-mediated dilation

  2 weeks

Secondary Outcomes (1)

• Blood markers of inflammation, oxidative stress, insulin resistance

  2 weeks

Study Arms (1)

resveratrol

EXPERIMENTAL

Resveratrol

Dietary Supplement: Resveratrol

Interventions

Resveratrol DIETARY_SUPPLEMENT

Resveratrol

Also known as: ResVida

resveratrol

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women who lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
• Treatment with an investigational product within the last 30 days.
• 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.
• Liver transaminase levels greater than 3X the upper limit of normal.
• History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
• Vitamin supplements exceeding two times the recommending daily allowance (RDA) within the last 30 days prior to screening.
• Resveratrol, green tea and isoflavone supplements within the last 30 days prior to screening.
• Subjects who practice a vegetarian or vegan diet
• 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.

Sponsors & Collaborators

• Boston University: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Joseph A Vita, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2009
• First Posted: December 23, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 21, 2010

Record last verified: 2010-08

Locations

US (1)