Effects of Resveratrol on Endothelial Function in Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881347
• Other study ID #: H-32036
• Secondary ID: 5P01HL068758-10
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: February 27, 2018
• Start date: January 1, 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2016
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in Serum glucose		2 and 4 weeks
Other	Change from Baseline in Serum insulin		2 and 4 weeks
Other	Change from Baseline in Mononuclear cell mitochondrial DNA damage		4 weejs
Other	Change from Baseline in Mononuclear cell mitochondrial mass		4 weeks
Other	Change from Baseline in Mononuclear cell mitochondrial production of reactive oxygen species		4 weeks
Other	Change from Baseline in Endothelial cell gene expression		4 weeks
Other	Change from Baseline in Endothelial cell protein expression		4 weeks
Primary	Change from baseline in Brachial artery flow mediated dilation		2 hours, 2 weeks, and 4 weeks
Secondary	Change from Baseline in Fingertip peripheral arterial tonometry		2 hours, 2 weeks, and 4 weeks
Secondary	Change from Baseline in Carotid femoral pulse wave velocity		4 weeks
Secondary	Change from Baseline in Reactive hyperemia		2 hours, 2 weeks, 4 weeks