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

Submitted by Anonymous (not verified) on
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.
Brief Title
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
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.
Categories
Diabetes
Diabetes & Endocrine System
Endocrine System Cancers
Cancer
Completion Date
Completion Date Type
Actual
Conditions
Type 2 Diabetes Mellitus
Insulin Resistance
Eligibility Criteria
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
Inclusion Criteria
Inclusion Criteria:

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

Gender
All
Gender Based
false
Keywords
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Resveratrol
Therapeutic Uses
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
45 Years
NCT Id
NCT01354977
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2007-534
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Primary Outcomes
Outcome Description
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).
Outcome Measure
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
Outcome Time Frame
4 weeks
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
4 weeks
Outcome Measure
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.
Outcome Description
Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.
Outcome Time Frame
4 weeks
Outcome Measure
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers
Outcome Description
Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo
Outcome Time Frame
4 weeks
Outcome Measure
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks
Outcome Description
Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment
Outcome Time Frame
4 Weeks
Outcome Measure
Muscle Mitochondrial Area
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
45
Investigators
Investigator Type
Principal Investigator
Investigator Name
Meredith Hawkins
Investigator Email
meredith.hawkins@einsteinmed.org
Investigator Phone
718-430-3186