Resveratrol in Type2 Diabetes and Obesity

NCT ID: NCT01158417

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-07-08

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.

Conditions

Type 2 Diabetes; Obesity; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Resveratrol 40 mg oral three times a day

Resveratrol

Group Type: EXPERIMENTAL

Resveratrol 40 mg oral three times a day

Intervention Type: DRUG

Drug

resveratrol 500 mg oral once daily.

Resveratrol

Group Type: EXPERIMENTAL

Resveratrol 500 mg oral once daily.

Intervention Type: DRUG

Resveratrol 500 mg oral once daily.

Interventions

Placebo

oral

Intervention Type: DRUG

Resveratrol 40 mg oral three times a day

Drug

Intervention Type: DRUG

Resveratrol 500 mg oral once daily.

Resveratrol 500 mg oral once daily.

Intervention Type: DRUG

Other Intervention Names

Resveratrol 40mg; Resveratrol 500 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaleida Health

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Paresh Dandona

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paresh Dandona, MD

Role: PRINCIPAL_INVESTIGATOR

Kaleida Health

Locations

Jeanne Hejna

Williamsville, New York, United States

Countries

United States

Other Identifiers

1935

Identifier Type: -

Identifier Source: org_study_id