Resveratrol in Type2 Diabetes and Obesity
This study is ongoing, but not recruiting participants.
Sponsor:
Kaleida Health
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
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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:
- 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.
Contacts and Locations 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 June 17, 2013