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DHEA and Testosterone Replacement in Elderly

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: NCT00254371
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : May 23, 2011
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE November 14, 2005
First Posted Date  ICMJE November 16, 2005
Last Update Posted Date May 23, 2011
Study Start Date  ICMJE July 1998
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
  • body composition (fat percent, fat free mass, abdominal visceral fat, and thigh muscle area)
  • bone parameters (BMD of ultradistal radius, femur neck, femur total and anterior-posterior of L2-L4 spine
  • fasting plasma insulin and glucose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
  • quality of life
  • glucose and insulin after mixed meal
  • muscle protein synthesis
  • hormone levels
  • prostate size
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DHEA and Testosterone Replacement in Elderly
Official Title  ICMJE Pathogenesis of Sarcopenia and Metabolic Changes in Aging
Brief Summary

Sarcopenia is a major health problem among the rapidly expanding elderly population in our society. Disabilities directly related to muscle weakness, and indirectly related to changes in body composition and metabolic dysfunctions, are causing a staggering toll in disability and health care costs.

Osteopenia occurs almost simultaneously with sarcopenia in the elderly population and muscle weakness increases the risk for falls and therefore, fractures. Although these issues have been separate addressed in several studies, an integrated investigational approach to better understand the pathogenesis of sarcopenia and other age-related metabolic abnormalities and to investigate the potential role of androgens have not been undertaken in a comprehensive manner.

The program contains four independent research programs, each representing different research disciplines, and four separate cores supporting the four projects.

The main focus of the project is to determine the effect of the replacement of testosterone in elderly men and DHEA in elderly men and women and to compare these effects with placebo treatment over a two-year period.

Project 1, "Effect of Androgen Replacement on Muscle Metabolism" will specifically determine whether these interventions have a differential effect on size and quality of muscle in terms of strength and metabolic functions. Project 2, "Effect of Androgen Replacement on Bone Metabolism," will determine the effects of this intervention on bone mineral density and markers of bone turnover.

Project 3, "The Effect of Androgen Replacement on Carbohydrate Metabolism," will determine whether the age-associated decrease in circulating androgens contributes to the alterations in carbohydrate metabolism that are commonly observed in the elderly and on insulin action, insulin secretion, and glucose effectiveness.

Project 4, "Effect of Androgen Replacement on Fat Metabolism" will determine whether changes in fat distribution that occur with aging could result from differences in regional fatty acid uptake and systemic fatty acid kinetics, and whether these determinants of fat distribution are altered by the interventions.

The data emerging from these studies will be integrated to determine the intervention of sarcopenia with other metabolic changes and hopefully will contribute to a better understanding of muscle, bone, carbohydrate and fat metabolism.

This study will hopefully form the scientific basis for future trials of androgen replacement in the elderly.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Aging
  • Low DHEA for Women
  • Low Testosterone and DHEA for Men
Intervention  ICMJE Procedure: Androgen Replacement
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: November 14, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

bioavailable testosterone less than 103 nanogram/dl and DHEA-S level less than 157 microgram/dl for men; DHEA-S less than 95 microgram/dl for women;

Exclusion criteria:

significant ischemic heart disease, renal disease, uncontrolled hypertension, diabetes mellitus, malignancy, malabsorption, bone disorders, chronic obstructive pulmonary disease, or sleep apnea.

Others exclusion criteria include abnormal serum calcium, phosphorus, alkaline phosphatase, asparate aminotransferase, creatinine, urinary calcium, thyroid stimulating hormone, and erythrocyte sedimentation rate.

People taking medication that may affect outcome measures such as adrenal steroids, anticonvulsant therapy thiazide diuretics, and estrogen replacement were also excluded. People engaged in a regular exercise program lasting more than 20 minutes more than two times per week and those men whose PSA level (age adjusted upper limit) were also excluded.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, 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 NCT00254371
Other Study ID Numbers  ICMJE 547-96
P01AG014383 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: K. Sreekumaran Nair, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2011

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