Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00111930
First received: May 26, 2005
Last updated: December 9, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention
Healthy
Drug: DHEA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Biological Effects of DHEA in the Elderly

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • bone mineral density
  • body composition

Secondary Outcome Measures:
  • blood lipids/lipoproteins
  • glucose tolerance
  • arterial compliance
  • visceral adiposity
  • quality of life
  • sex steroids and growth factors
  • sexual health
  • cognitive function

Estimated Enrollment: 144
Study Start Date: August 2000
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111930

Locations
United States, Colorado
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
Investigators
Principal Investigator: Wendy M. Kohrt, PhD University of Colorado, Denver
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00111930     History of Changes
Other Study ID Numbers: AG0019, AG018857
Study First Received: May 26, 2005
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
dehydroepiandrosterone
DHEAS
bone mineral density
body composition
lean mass
fat mass
bone mass
decreased DHEAS levels

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014