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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038089
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : December 21, 2010
DSM Nutritional Products, Inc.
Information provided by:
Boston University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Resveratrol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study Of The Effects Of Resveratrol On Endothelial Function In Subjects With Type 2 Diabetes Mellitus
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: resveratrol
Dietary Supplement: Resveratrol
Other Name: ResVida

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Blood markers of inflammation, oxidative stress, insulin resistance [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038089

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
DSM Nutritional Products, Inc.
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Principal Investigator: Joseph A Vita, MD Boston University

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Responsible Party: Joseph A. Vita, MD, Boston University School of Medicine Identifier: NCT01038089    
Other Study ID Numbers: H-28258
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: December 21, 2010
Last Verified: August 2010
Keywords provided by Boston University:
diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents