Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

NCT ID: NCT01881347

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active First

Active resveratrol first, placebo second

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo first

Placebo first, active resveratrol second

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Resveratrol

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi Hamburg, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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5P01HL068758-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-32036

Identifier Type: -

Identifier Source: org_study_id

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