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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resveratrol

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring endothelium, resveratrol, diabetes mellitus

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

resveratrol

Arm Description

Resveratrol

Outcomes

Primary Outcome Measures

Brachial artery flow-mediated dilation

Secondary Outcome Measures

Blood markers of inflammation, oxidative stress, insulin resistance

Full Information

NCT ID

NCT01038089

First Posted

December 19, 2009

Last Updated

December 17, 2010

Sponsor

Boston University

Collaborators

DSM Nutritional Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01038089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston University

Collaborators

DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

endothelium, resveratrol, diabetes mellitus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

resveratrol

Arm Type

Experimental

Arm Description

Resveratrol

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol

Other Intervention Name(s)

ResVida

Intervention Description

Resveratrol

Primary Outcome Measure Information:

Title

Brachial artery flow-mediated dilation

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Blood markers of inflammation, oxidative stress, insulin resistance

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph A Vita, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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