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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038089
• Other study ID #: H-28258
• Status: Completed
• Phase: N/A
• First received: December 19, 2009
• Last updated: December 17, 2010
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2010
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Resveratrol
Resveratrol

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilation		2 weeks	No
Secondary	Blood markers of inflammation, oxidative stress, insulin resistance		2 weeks	No