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

July 7, 2010
December 17, 2012
December 2008
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01158417 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Resveratrol in Type2 Diabetes and Obesity
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 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Obesity
  • Insulin Resistance
  • Drug: Placebo
    oral
  • Drug: Resveratrol 40 mg oral three times a day
    Drug
  • Drug: Resveratrol 500 mg oral once daily.
    Resveratrol 500 mg oral once daily.
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo
  • Experimental: Resveratrol 40 mg oral three times a day
    Resveratrol
    Intervention: Drug: Resveratrol 40 mg oral three times a day
  • Experimental: resveratrol 500 mg oral once daily.
    Resveratrol
    Intervention: Drug: Resveratrol 500 mg oral once daily.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
August 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01158417
1935
No
Paresh Dandona, MD, Kaleida Health
Kaleida Health
Not Provided
Principal Investigator: Paresh Dandona, MD Kaleida Health
Kaleida Health
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP