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Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01881347
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Boston University

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : March 1, 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Active First
Active resveratrol first, placebo second
Dietary Supplement: Resveratrol
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

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

Experimental: Placebo first
Placebo first, active resveratrol second
Dietary Supplement: Resveratrol
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

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




Primary Outcome Measures :
  1. Change from baseline in Brachial artery flow mediated dilation [ Time Frame: 2 hours, 2 weeks, and 4 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in Fingertip peripheral arterial tonometry [ Time Frame: 2 hours, 2 weeks, and 4 weeks ]
  2. Change from Baseline in Carotid femoral pulse wave velocity [ Time Frame: 4 weeks ]
  3. Change from Baseline in Reactive hyperemia [ Time Frame: 2 hours, 2 weeks, 4 weeks ]

Other Outcome Measures:
  1. Change from Baseline in Serum glucose [ Time Frame: 2 and 4 weeks ]
  2. Change from Baseline in Serum insulin [ Time Frame: 2 and 4 weeks ]
  3. Change from Baseline in Mononuclear cell mitochondrial DNA damage [ Time Frame: 4 weejs ]
  4. Change from Baseline in Mononuclear cell mitochondrial mass [ Time Frame: 4 weeks ]
  5. Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species [ Time Frame: 4 weeks ]
  6. Change from Baseline in Endothelial cell gene expression [ Time Frame: 4 weeks ]
  7. Change from Baseline in Endothelial cell protein expression [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT01881347


Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Naomi Hamburg, MD Boston University

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01881347     History of Changes
Other Study ID Numbers: H-32036
5P01HL068758-10 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston University:
endothelium
mitochondria
reactive oxygen species
vascular biology
arterial stiffness
nitric oxide

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
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents