Resveratrol in Type2 Diabetes and Obesity

Not Applicable

Terminated

• Conditions: Obesity; Type 2 Diabetes; Insulin Resistance
• Interventions: Drug: Resveratrol 500 mg oral once daily.; Drug: Placebo; Drug: Resveratrol 40 mg oral three times a day

• Registration Number: NCT01158417
• Lead Sponsor: University at Buffalo

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2012-07-08
• Study Completion: 2012-07-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resveratrol 500 mg oral once daily.	Resveratrol 500 mg oral once daily.	Resveratrol
Placebo	Placebo	Placebo tablets
Resveratrol 40 mg oral three times a day	Resveratrol 40 mg oral three times a day	Resveratrol

Primary Outcome Measures

Name	Time	Method
NF-Kb	12 weeks	To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB

Secondary Outcome Measures

Name	Time	Method
GLP-1	12 weeks	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

Trial Locations

Locations (1)

Jeanne Hejna; 🇺🇸 Williamsville, New York, United States