Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus
NCT ID: NCT01881347
Last Updated: 2018-03-01
Study Results
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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COMPLETED
NA
54 participants
INTERVENTIONAL
2013-01-01
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active First
Active resveratrol first, placebo second
Resveratrol
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.
Placebo
Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
Placebo first
Placebo first, active resveratrol second
Resveratrol
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.
Placebo
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.
Placebo
Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* Age over 21 years old
* Body mass index less than 38 kg/m2
* Clinical stable type 2 diabetes mellitus
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Boston University
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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H-32036
Identifier Type: -
Identifier Source: org_study_id
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