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. 2020 Jan 17;2020(1):CD011919. doi: 10.1002/14651858.CD011919.pub2

NCT01158417.

Trial name or title Acronym:
Methods Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: single‐blind (participant)
Primary purpose: treatment
Participants Condition: type 2 diabetes mellitus, obesity, and Insulin resistance
Enrolment: estimated 102
Inclusion criteria
  • 20 years of age or older

  • Healthy obese patients with BMI > 30

  • Type 2 diabetic patients with BMI > 30

  • Patients with good peripheral vein

  • Patients on statins, ACE inhibitors, and thiazolidinediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of the study


Exclusion criteria
  • Patients on any anti‐oxidant medication

  • Patients on non‐steroidal anti‐inflammatory drugs

  • Patients on any agent with significant anti‐oxidant 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 previous 4 weeks

  • Patients on anticoagulants

Interventions Intervention(s): resveratrol (40 mg oral 3 times a day or 500 mg oral once daily)
Comparator(s): placebo tablets
Outcomes Primary outcome(s): NF‐Kb
Secondary outcome(s): GLP‐1
Other outcome(s):
Starting date Trial start date: December 2008
Trial completion date: August 2014 (estimated)
Contact information Responsible party/principal investigator: Paresh Dandona, MD, Kaleida Health
Study identifier Trial identifier:NCT01158417
Official title Effect of resveratrol on insulin resistance and inflammatory mediators in obese and type 2 diabetic subjects
Stated purpose of study Quote: "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"
Notes