Resveratrol in Type2 Diabetes and Obesity
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|
|Start date||December 2008|
|End date||April 2014|
|Trial size||102 participants|
|Trial identifier||NCT01158417, 1935|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
time frame: 12 weeks
time frame: 12 weeks
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.
|Official title||Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects|
|Principal investigator||Paresh Dandona, MD|
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