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NCT Number: NCT01881347

Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change from baseline in Brachial artery flow mediated dilation

    Time frame: 2 hours, 2 weeks, and 4 weeks

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 19, 2013
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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