Clinical trial NCT01881347: Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus
Official title: Randomized Crossover Study of The Effects of Resveratrol on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: endothelium
mitochondria
reactive oxygen species
vascular biology
arterial stiffness
nitric oxide
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-06-19
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in Brachial artery flow mediated dilation
timeFrame: 2 hours, 2 weeks, and 4 weeks
Secondary outcomes:
measure: Change from Baseline in Fingertip peripheral arterial tonometry
timeFrame: 2 hours, 2 weeks, and 4 weeks
measure: Change from Baseline in Carotid femoral pulse wave velocity
timeFrame: 4 weeks
measure: Change from Baseline in Reactive hyperemia
timeFrame: 2 hours, 2 weeks, 4 weeks
Other outcomes:
measure: Change from Baseline in Serum glucose
timeFrame: 2 and 4 weeks
measure: Change from Baseline in Serum insulin
timeFrame: 2 and 4 weeks
measure: Change from Baseline in Mononuclear cell mitochondrial DNA damage
timeFrame: 4 weejs
measure: Change from Baseline in Mononuclear cell mitochondrial mass
timeFrame: 4 weeks
measure: Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species
timeFrame: 4 weeks
measure: Change from Baseline in Endothelial cell gene expression
timeFrame: 4 weeks
measure: Change from Baseline in Endothelial cell protein expression
timeFrame: 4 weeks
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Naomi Hamburg, MD
role: PRINCIPAL_INVESTIGATOR
References: