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

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ClinicalTrials.gov Identifier: NCT01354977
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine, Inc.

Brief Summary:
Human aging is associated with increased fat mass, insulin resistance and systemic inflammation. In addition to overall increases in fat mass, accumulation of lipid in such insulin-sensitive tissues as liver and skeletal muscle appears to contribute importantly to insulin resistance. Furthermore, age-related decreases in muscle mitochondrial ATP production rate and mitochondrial DNA copy number are likely to contribute to impaired insulin-mediated glucose disposal, as well as decreased muscular endurance and activity levels. Additionally, systemic inflammation is now believed to contribute to insulin resistance and thus ultimately to many age-related disorders, including diabetes mellitus, Alzheimer's disease, atherosclerosis and many cancers.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Insulin Resistance Drug: Resveratrol Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Actual Study Start Date : March 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
Drug: Resveratrol
1,000mg twice daily for 28 days




Primary Outcome Measures :
  1. Peripheral Insulin Sensitivity [ Time Frame: Four weeks ]
    We will measure peripheral insulin sensitivity by determining the rate of glucose uptake


Secondary Outcome Measures :
  1. Hepatic insulin sensitivity [ Time Frame: 4 weeks ]
    Endogenous glucose production will be used to determine hepatic insulin sensitivity

  2. Muscle mitochondrial function [ Time Frame: 4 weeks ]
    Muscle mitochondrial structure by electron microscopy and function by enzymatic assays.

  3. Inflammatory and Anti-inflammatory Markers in adipose tissue [ Time Frame: 1 month ]
    Inflammatory Markers: PAI-1, IL-6, TNF-a, iNOS Anti-inflammatory Markers: Adiponectin, Arginase 1 Will be measured in plasma

  4. Neuropsychological assessment [ Time Frame: pre and post clamp studies (4 weeks) ]
    Neuropsychological testing will be performed to assess cognitive function.



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354977


Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Meredith A Hawkins, M.D., M.S. Albert Einstein College of Medicine, Inc.

Responsible Party: Meredith Hawkins, Principal Investigator, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01354977     History of Changes
Other Study ID Numbers: 2007-534
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Resveratrol
Diabetes Mellitus
Inflammation
Diabetes Mellitus, Type 2
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
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents