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NCT Number: NCT01354977

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Drug

1,000mg twice daily for 28 days

Other names: 3,5,4'-trihydroxy-trans-stilbene

Primary outcomes

  1. Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.

    Time frame: 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 outcomes

  1. Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.

    Time frame: 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).

  2. Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers

    Time frame: 4 weeks

    Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.

  3. Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks

    Time frame: 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. Muscle Mitochondrial Area

    Time frame: 4 Weeks

    Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
May 17, 2011
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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