Resveratrol in Type2 Diabetes and Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01158417
First received: July 7, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Obesity
Insulin Resistance
Drug: Placebo
Drug: Resveratrol 40 mg oral three times a day
Drug: Resveratrol 500 mg oral once daily.
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects

Resource links provided by NLM:


Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • NF-Kb [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB


Secondary Outcome Measures:
  • GLP-1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 102
Study Start Date: December 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo tablets
Drug: Placebo
oral
Experimental: Resveratrol 40 mg oral three times a day
Resveratrol
Drug: Resveratrol 40 mg oral three times a day
Drug
Experimental: resveratrol 500 mg oral once daily.
Resveratrol
Drug: Resveratrol 500 mg oral once daily.
Resveratrol 500 mg oral once daily.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158417

Locations
United States, New York
115 Flint Road
Buffalo, New York, United States, 14221
Sponsors and Collaborators
Kaleida Health
Investigators
Principal Investigator: Paresh Dandona, MD Kaleida Health
  More Information

Additional Information:
No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT01158417     History of Changes
Other Study ID Numbers: 1935
Study First Received: July 7, 2010
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaleida Health:
Type 2 Diabetes
Obesity
Insulin Resistance
Resveratrol
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014