Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01881347
First received: June 14, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention
Diabetes Mellitus
Dietary Supplement: Resveratrol
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Change from baseline in Brachial artery flow mediated dilation [ Time Frame: 2 hours, 2 weeks, and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Fingertip peripheral arterial tonometry [ Time Frame: 2 hours, 2 weeks, and 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Carotid femoral pulse wave velocity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Reactive hyperemia [ Time Frame: 2 hours, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline in Serum glucose [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Serum insulin [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mononuclear cell mitochondrial DNA damage [ Time Frame: 4 weejs ] [ Designated as safety issue: No ]
  • Change from Baseline in Mononuclear cell mitochondrial mass [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Endothelial cell gene expression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Endothelial cell protein expression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  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: NCT01881347

Locations
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Monika Holbrook, MS       monica.holbrook@bmc.org   
Principal Investigator: Joseph A Vita, MD         
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01881347     History of Changes
Other Study ID Numbers: H-32036, 5P01HL068758-10
Study First Received: June 14, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
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 23, 2014