- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354977
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resveratrol
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
|
1,000mg twice daily for 28 days
Other Names:
|
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.
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). |
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.
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). |
4 weeks
|
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.
|
4 weeks
|
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 weeks
|
Muscle Mitochondrial Area
Time Frame: 4 Weeks
|
Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment
|
4 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Meredith A Hawkins, M.D., M.S., Albert Einstein College Of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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