Diabetes Mellitus
Conditions
Keywords
endothelium, mitochondria, reactive oxygen species, vascular biology, arterial stiffness, nitric oxide
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.
Interventions
DIETARY_SUPPLEMENTResveratrol
Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Brachial artery flow mediated dilation | 2 hours, 2 weeks, and 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Fingertip peripheral arterial tonometry | 2 hours, 2 weeks, and 4 weeks |
| Change from Baseline in Carotid femoral pulse wave velocity | 4 weeks |
| Change from Baseline in Reactive hyperemia | 2 hours, 2 weeks, 4 weeks |
Other
| Measure | Time frame |
|---|---|
| Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species | 4 weeks |
| Change from Baseline in Serum glucose | 2 and 4 weeks |
| Change from Baseline in Endothelial cell protein expression | 4 weeks |
| Change from Baseline in Endothelial cell gene expression | 4 weeks |
| Change from Baseline in Serum insulin | 2 and 4 weeks |
| Change from Baseline in Mononuclear cell mitochondrial DNA damage | 4 weejs |
| Change from Baseline in Mononuclear cell mitochondrial mass | 4 weeks |
Countries
United States
Outcome results
None listed