Resveratrol in Type2 Diabetes and Obesity

Study Overview
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Brief Summary
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The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.

Detailed Description
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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.

Official Title
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Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects

Conditions
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Obesity, Type 2 Diabetes, Insulin Resistance

Intervention / Treatment
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* Drug: Placebo
* Drug: Resveratrol 40 mg oral three times a day
* Drug: Resveratrol 500 mg oral once daily.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years of age and older Healthy Obese subjects with BMI > 30 Type 2 Diabetics with BMI > 30 Subjects with good peripheral vein. 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: Subjects on any antioxidant medication Patient on non-steroidal anti-inflammatory drug On any agent with significant antioxidant properties. History of drug or alcohol abuse Any life threatening disease Allergy to peanuts, grapes, wine, mulberries. Pregnant women. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. Subjects on anticoagulants.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo tablets | Drug: Placebo<br>* oral<br>|
| Experimental: Resveratrol 40 mg oral three times a day<br>Resveratrol | Drug: Resveratrol 40 mg oral three times a day<br>* Drug<br>* Other names: Resveratrol 40mg;|
| Experimental: resveratrol 500 mg oral once daily.<br>Resveratrol | Drug: Resveratrol 500 mg oral once daily.<br>* Resveratrol 500 mg oral once daily.<br>* Other names: Resveratrol 500 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NF-Kb | To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 | To see whether Resveratrol leads to a greater stimulation of the incretin system and secretion/release of GIP and GLP-1 when compared to that following placebo | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation