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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 : Terminated (FDA clinical hold requiring IND submission, product not available in the market anymore)
First Posted : July 8, 2010
Last Update Posted : November 9, 2022
Sponsor:
Collaborator:
Kaleida Health
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

Study Description
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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.

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. Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 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
Actual Study Start Date : December 2008
Actual Primary Completion Date : July 8, 2012
Actual Study Completion Date : July 8, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arms and Interventions
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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
Other Name: Resveratrol 40mg
Experimental: resveratrol 500 mg oral once daily.
Resveratrol
 Drug: Resveratrol 500 mg oral once daily.
Resveratrol 500 mg oral once daily.
Other Name: Resveratrol 500 mg


Outcome Measures
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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


Eligibility Criteria
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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.
Contacts and Locations
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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
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United States, New York
Jeanne Hejna
Williamsville, New York, United States, 14221
Sponsors and Collaborators
University at Buffalo
Kaleida Health
Investigators
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Principal Investigator: Paresh Dandona, MD Kaleida Health
More Information
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Responsible Party: Paresh Dandona, MD, University at Buffalo
ClinicalTrials.gov Identifier: NCT01158417    
Other Study ID Numbers: 1935
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paresh Dandona, University at Buffalo:
Type 2 Diabetes
Obesity
Insulin Resistance
Resveratrol
Inflammation
Additional relevant MeSH terms:
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Resveratrol
Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Hyperinsulinism
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Platelet Aggregation Inhibitors