ClinicalTrials.gov
ClinicalTrials.gov Menu

Resveratrol in Type2 Diabetes and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158417
Recruitment Status : Unknown
Verified December 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was:  Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
Study Start Date : December 2008
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. NF-Kb [ Time Frame: 12 weeks ]
    To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB


Secondary Outcome Measures :
  1. GLP-1 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT01158417     History of Changes
Other Study ID Numbers: 1935
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Paresh Dandona, MD, Kaleida Health:
Type 2 Diabetes
Obesity
Insulin Resistance
Resveratrol
Inflammation

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