Resveratrol in Type2 Diabetes and Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01158417
• Other study ID #: 1935
• Status: Terminated
• Phase: N/A
• Start date: December 2008
• Est. completion date: July 8, 2012

Study information

• Verified date: November 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 8, 2012
• Est. primary completion date: July 8, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• Placebo
oral
• Resveratrol 40 mg oral three times a day
Drug
• Resveratrol 500 mg oral once daily.
Resveratrol 500 mg oral once daily.

Locations

Country	Name	City	State
United States	Jeanne Hejna	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Kaleida Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NF-Kb	To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB	12 weeks
Secondary	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