Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, obesity, insulin resistance
Treatments placebo, resveratrol 40 mg oral three times a day, resveratrol 500 mg oral once daily.
Phase phase 2/phase 3
Sponsor Kaleida Health
Start date December 2008
End date April 2014
Trial size 102 participants
Trial identifier NCT01158417, 1935

Summary

The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo tablets
placebo
oral
(Experimental)
Resveratrol
resveratrol 40 mg oral three times a day
Drug
(Experimental)
Resveratrol
resveratrol 500 mg oral once daily.
Resveratrol 500 mg oral once daily.

Primary Outcomes

Measure
NF-Kb
time frame: 12 weeks

Secondary Outcomes

Measure
GLP-1
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: 1. 20 years of age and older 2. Healthy Obese subjects with BMI > 30 3. Type 2 Diabetics with BMI > 30 4. Subjects with good peripheral vein. 5. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study. Exclusion Criteria: 1. Subjects on any antioxidant medication 2. Patient on non-steroidal anti-inflammatory drug 3. On any agent with significant antioxidant properties. 4. History of drug or alcohol abuse 5. Any life threatening disease 6. Allergy to peanuts, grapes, wine, mulberries. 7. Pregnant women. 8. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. 9. Subjects on anticoagulants.

Additional Information

Official title Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
Principal investigator Paresh Dandona, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Kaleida Health.