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

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes Mellitus
Insulin Resistance

Treatments

Drug: Resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT01354977
2007-534

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Resveratrol
Experimental group
Description:
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
Treatment:
Drug: Resveratrol

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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