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Resveratrol in Type2 Diabetes and Obesity

U

University at Buffalo

Status

Terminated

Conditions

Insulin Resistance
Obesity
Type 2 Diabetes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo tablets
Treatment:
Drug: Placebo
Resveratrol 40 mg oral three times a day
Experimental group
Description:
Resveratrol
Treatment:
Drug: Resveratrol 40 mg oral three times a day
resveratrol 500 mg oral once daily.
Experimental group
Description:
Resveratrol
Treatment:
Drug: Resveratrol 500 mg oral once daily.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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