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Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly
This study has been completed.
Study NCT00111930   Information provided by National Institute on Aging (NIA)
First Received: May 26, 2005   Last Updated: February 17, 2009   History of Changes

May 26, 2005
February 17, 2009
August 2000
 
  • bone mineral density
  • body composition
Same as current
Complete list of historical versions of study NCT00111930 on ClinicalTrials.gov Archive Site
  • blood lipids/lipoproteins
  • glucose tolerance
  • arterial compliance
  • visceral adiposity
  • quality of life
  • sex steroids and growth factors
  • sexual health
  • cognitive function
Same as current
 
Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly
Biological Effects of DHEA in the Elderly

The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass).

The central hypothesis of this study is that restoring circulating levels of the adrenal hormone dehydroepiandrosterone (DHEA) in older people with low levels to more youthful levels will be associated with beneficial changes in lean mass, fat mass and bone mass.

This will be a randomized, placebo-controlled, double-blinded study. Seventy-two men and 72 women, over 60 years old, who are healthy, will be randomized to receive either a replacement dose of DHEA or placebo for 1 year. The replacement dose of DHEA will bring circulating DHEA sulfate (DHEAS) levels into the range of normal in healthy 20-30 year-old women (approximately 8 micromoles per liter [μM] or 295 micrograms per deciliter [µg/dL]) and men (approximately 10 micromoles per liter [μM] or 368 micrograms per deciliter [µg/dL]).

Fat mass and fat-free body mass will be evaluated by dual energy x-ray absorptiometry (DXA), and intra-abdominal fat volume and thigh muscle area will be measured by computed tomography (CT). Bone mineral density (BMD) of the total body, lumbar spine, and proximal femur will be measured by DXA and biochemical markers of bone resorption and formation. Glucose tolerance and insulin response will be evaluated using an oral glucose tolerance test.

If this study confirms the results of a previous preliminary study, the current study is likely to impact future scientific study regarding the role of DHEA deficiency in the biology of aging and its role as a therapeutic agent for the prevention of sarcopenia.

 
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Healthy
Drug: DHEA
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
144
March 2005
 

Inclusion Criteria:

  • Healthy women and men
  • Age 60 or older
  • Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old

Exclusion Criteria:

  • Contraindications to DHEA treatment (personal history of breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding in women, history or evidence of prostate cancer or benign prostatic hyperplasia (BPH) in men)
  • Angina
  • Resting blood pressure over 180/95
  • Chronic infections
  • Hypothyroidism
  • Depression
  • Hormone therapy within the previous 6 months
  • Insulin-dependent or poorly controlled diabetes
  • Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL)

Prohibited Medications:

  • Hormone therapy other than stable regimen of thyroid replacement
  • Oral glucocorticoids
  • Insulin
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00111930
 
AG0019, AG018857
National Institute on Aging (NIA)
 
Principal Investigator: Wendy M. Kohrt, PhD University of Colorado at Denver and Health Sciences Center
National Institute on Aging (NIA)
February 2009

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