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

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01038089
First received: December 19, 2009
Last updated: December 17, 2010
Last verified: August 2010
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Resveratrol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood markers of inflammation, oxidative stress, insulin resistance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resveratrol
Resveratrol
Dietary Supplement: Resveratrol
Resveratrol
Other Name: ResVida

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038089

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

No publications provided

Responsible Party: Joseph A. Vita, MD, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT01038089     History of Changes
Other Study ID Numbers: H-28258
Study First Received: December 19, 2009
Last Updated: December 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
endothelium
resveratrol
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014