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

This study is currently recruiting participants.
Verified May 2011 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01354977
First received: May 12, 2011
Last updated: May 16, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this research is to study the effects of a medication called resveratrol on the body's response to insulin (a hormone to control blood sugar), on inflammation and/or on specific cells and processes in fat tissue, and on skeletal muscle metabolism and on brain function.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Insulin Resistance
 Drug: Resveratrol
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Resource links provided by NLM:

Drug Information available for: Resveratrol
U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Peripheral Insulin Sensitivity [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    We will measure peripheral insulin sensitivity by determining the rate of glucose uptake


Secondary Outcome Measures:
  • Hepatic insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Endogenous glucose production will be used to determine hepatic insulin sensitivity

  • Muscle mitochondrial function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Muscle mitochondrial structure by electron microscopy and function by enzymatic assays.

  • Inflammatory and Anti-inflammatory Markers in adipose tissue [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Inflammatory Markers: PAI-1, IL-6, TNF-a, iNOS Anti-inflammatory Markers: Adiponectin, Arginase 1 Will be measured in plasma

  • Neuropsychological assessment [ Time Frame: pre and post clamp studies (4 weeks) ] [ Designated as safety issue: No ]
    Neuropsychological testing will be performed to assess cognitive function.


Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resveratrol
Resveratrol
 Drug: Resveratrol
1,000mg twice daily for 28 days

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354977

Contacts
Contact: Stephanie Lawrence 718-430-2903 stephanie.lawrence@einstein.yu.edu

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Stephanie Lawrence     718-430-2903     stephanie.lawrence@einstein.yu.edu    
Principal Investigator: Preeti Kishore, MD            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Preeti Kishore, M.D., Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01354977     History of Changes
Other Study ID Numbers: 2007-534
Study First Received: May 12, 2011
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
 Endocrin System Diseases
Resveratrol
Therapeutic Uses

Additional relevant MeSH terms:
Resveratrol
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents

ClinicalTrials.gov processed this record on May 16, 2013