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Trial record 70 of 235 for:    PRASTERONE

Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00099697
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : December 11, 2009
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE December 17, 2004
First Posted Date  ICMJE December 20, 2004
Last Update Posted Date December 11, 2009
Study Start Date  ICMJE June 2001
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
6-month change in visceral and subcutaneous abdominal fat
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00099697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans
Official Title  ICMJE Biologic Effects of DHEA in Humans
Brief Summary The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.
Detailed Description

Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans.

Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Aging
  • Obesity
  • Insulin Resistance
Intervention  ICMJE Drug: DHEA
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
56
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 65 to 78 years old
  • Physically healthy
  • Non-smoker
  • On stable medications for at least 6 months
  • Stable body weight for the past year

Exclusion Criteria:

  • Serious active medical problems
  • Hormone therapy
  • Abnormal PSA (prostate specific antigen) in men
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 78 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00099697
Other Study ID Numbers  ICMJE AG0013
5P60AG013629 ( U.S. NIH Grant/Contract )
5R01AG020076 ( U.S. NIH Grant/Contract )
5K23RR016191 ( U.S. NIH Grant/Contract )
3P30DK056341 ( U.S. NIH Grant/Contract )
5P60DK020579 ( U.S. NIH Grant/Contract )
2M01RR000036 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: John O. Holloszy, MD Washington University School of Medicine
Principal Investigator: Dennis T. Villareal, MD Washington University School of Medicine
PRS Account National Institute on Aging (NIA)
Verification Date December 2004

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