- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158417
Resveratrol in Type2 Diabetes and Obesity
November 3, 2022 updated by: Paresh Dandona, University at Buffalo
Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Williamsville, New York, United States, 14221
- Jeanne Hejna
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20 years of age and older
- Healthy Obese subjects with BMI > 30
- Type 2 Diabetics with BMI > 30
- Subjects with good peripheral vein.
- 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:
- Subjects on any antioxidant medication
- Patient on non-steroidal anti-inflammatory drug
- On any agent with significant antioxidant properties.
- History of drug or alcohol abuse
- Any life threatening disease
- Allergy to peanuts, grapes, wine, mulberries.
- Pregnant women.
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
- Subjects on anticoagulants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablets
|
oral
|
Experimental: Resveratrol 40 mg oral three times a day
Resveratrol
|
Drug
Other Names:
|
Experimental: resveratrol 500 mg oral once daily.
Resveratrol
|
Resveratrol 500 mg oral once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NF-Kb
Time Frame: 12 weeks
|
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2008
Primary Completion (Actual)
July 8, 2012
Study Completion (Actual)
July 8, 2012
Study Registration Dates
First Submitted
July 7, 2010
First Submitted That Met QC Criteria
July 7, 2010
First Posted (Estimate)
July 8, 2010
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Hyperinsulinism
- Diabetes Mellitus, Type 2
- Obesity
- Insulin Resistance
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Antioxidants
- Resveratrol
Other Study ID Numbers
- 1935
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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