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Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resveratrol

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus focused on measuring endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Active First

Placebo first

Arm Description

Active resveratrol first, placebo second

Placebo first, active resveratrol second

Outcomes

Primary Outcome Measures

Change from baseline in Brachial artery flow mediated dilation

Secondary Outcome Measures

Change from Baseline in Fingertip peripheral arterial tonometry

Change from Baseline in Carotid femoral pulse wave velocity

Change from Baseline in Reactive hyperemia

Full Information

NCT ID

NCT01881347

First Posted

June 14, 2013

Last Updated

February 27, 2018

Sponsor

Boston University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01881347

Brief Title

Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Official Title

Randomized Crossover 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

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2013 (Actual)

Primary Completion Date

March 1, 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Diabetes Mellitus

Keywords

endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active First

Arm Type

Experimental

Arm Description

Active resveratrol first, placebo second

Arm Title

Placebo first

Arm Type

Experimental

Arm Description

Placebo first, active resveratrol second

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol

Intervention Description

Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.

Primary Outcome Measure Information:

Title

Change from baseline in Brachial artery flow mediated dilation

Time Frame

2 hours, 2 weeks, and 4 weeks

Secondary Outcome Measure Information:

Title

Change from Baseline in Fingertip peripheral arterial tonometry

Time Frame

2 hours, 2 weeks, and 4 weeks

Title

Change from Baseline in Carotid femoral pulse wave velocity

Time Frame

4 weeks

Title

Change from Baseline in Reactive hyperemia

Time Frame

2 hours, 2 weeks, 4 weeks

Other Pre-specified Outcome Measures:

Title

Change from Baseline in Serum glucose

Time Frame

2 and 4 weeks

Title

Change from Baseline in Serum insulin

Time Frame

2 and 4 weeks

Title

Change from Baseline in Mononuclear cell mitochondrial DNA damage

Time Frame

4 weejs

Title

Change from Baseline in Mononuclear cell mitochondrial mass

Time Frame

4 weeks

Title

Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species

Time Frame

4 weeks

Title

Change from Baseline in Endothelial cell gene expression

Time Frame

4 weeks

Title

Change from Baseline in Endothelial cell protein expression

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naomi Hamburg, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

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