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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Insulin Resistance
• Intervention / Treatment: Drug: Resveratrol

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resveratrol; Each participant will receive a 28 days' supply of resveratrol capsules on day 0.	Drug: Resveratrol; 1,000mg twice daily for 28 days; Other Names: 3,5,4'-trihydroxy-trans-stilbene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 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).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 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).	4 weeks
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers	Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.	4 weeks
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 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	4 weeks
Muscle Mitochondrial Area	Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment	4 Weeks

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Meredith A Hawkins, M.D., M.S., Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Resveratrol; Therapeutic Uses; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 2007-534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No