Clinical trial NCT01354977: Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Official title: Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Insulin Resistance
Keywords: Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Resveratrol
Therapeutic Uses
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
timeFrame: 4 weeks
Secondary outcomes:
measure: Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.
timeFrame: 4 weeks
measure: Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers
timeFrame: 4 weeks
measure: Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks
timeFrame: 4 weeks
measure: Muscle Mitochondrial Area
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Meredith A Hawkins, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: