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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.

May 12, 2011
May 17, 2011
April 23, 2018
March 2008
March 2015   (Final data collection date for primary outcome measure)
Peripheral Insulin Sensitivity [ Time Frame: Four weeks ]
We will measure peripheral insulin sensitivity by determining the rate of glucose uptake
Same as current
Complete list of historical versions of study NCT01354977 on ClinicalTrials.gov Archive Site
  • Hepatic insulin sensitivity [ Time Frame: 4 weeks ]
    Endogenous glucose production will be used to determine hepatic insulin sensitivity
  • Muscle mitochondrial function [ Time Frame: 4 weeks ]
    Muscle mitochondrial structure by electron microscopy and function by enzymatic assays.
  • 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
  • Neuropsychological assessment [ Time Frame: pre and post clamp studies (4 weeks) ]
    Neuropsychological testing will be performed to assess cognitive function.
Same as current
Not Provided
Not Provided
 
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Insulin Resistance
Drug: Resveratrol
1,000mg twice daily for 28 days
Experimental: Resveratrol
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
Intervention: Drug: Resveratrol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Same as current
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01354977
2007-534
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Meredith Hawkins, Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
Not Provided
Principal Investigator: Meredith A Hawkins, M.D., M.S. Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP