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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Insulin Resistance

Intervention / Treatment
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* Drug: Resveratrol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Resveratrol, Therapeutic Uses