Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Insulin Resistance
• Interventions: Drug: Resveratrol

• Registration Number: NCT01354977
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.

Detailed Description

Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Results First Submitted: 2021-07-19
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Results First Posted: 2022-03-08
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• BMI: 26-35
• Non-smoker
• Normal screening labs (CMC, chemistry, LFTs PT/PTT)
• No CAD
• Good IV access

Exclusion Criteria

• High cholesterol

• <4 week history of participation in another drug trial

• Severe hypertension

• Heart disease

• Liver disease of liver abnormalities

• Cerebrovascular disease, i.e. stroke

• CVD

• Seizures

• Bleeding disorders

• Muscle disease

• Cancer

• HIV

• Hepatitis (all types)

• Mentally disabled persons

• Pregnant women

• Allergies to Novocaine, Lidocaine, Benzocaine

• Subjects on the following medications:

  • Anticoagulant and antiplatelet drugs
  • Anti-epileptic drugs
  • Mexiletene
  • Quinidine
  • Cyclosporine
  • Tacrolimus
  • HIV protease inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Each participant will receive a 28 days' supply of resveratrol capsules on day 0.

Primary Outcome Measures

Name	Time	Method
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.	4 weeks	We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD).; RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).

Secondary Outcome Measures

Name	Time	Method
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.	4 weeks	Endogenous glucose production will be used to determine hepatic insulin sensitivity.; Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers	4 weeks	Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks	4 weeks	Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo
Muscle Mitochondrial Area	4 Weeks	Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States