Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly
NCT ID: NCT00111930
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
144 participants
INTERVENTIONAL
2000-08-31
2005-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DHEA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 60 or older
* Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old
Exclusion Criteria
* 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
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wendy M. Kohrt, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Villareal DT, Holloszy JO. Effect of DHEA on abdominal fat and insulin action in elderly women and men: a randomized controlled trial. JAMA. 2004 Nov 10;292(18):2243-8. doi: 10.1001/jama.292.18.2243.
Legrain S, Girard L. Pharmacology and therapeutic effects of dehydroepiandrosterone in older subjects. Drugs Aging. 2003;20(13):949-67. doi: 10.2165/00002512-200320130-00001.
Kahn AJ, Halloran B, Wolkowitz O, Brizendine L. Dehydroepiandrosterone supplementation and bone turnover in middle-aged to elderly men. J Clin Endocrinol Metab. 2002 Apr;87(4):1544-9. doi: 10.1210/jcem.87.4.8396.
Nippoldt TB, Nair KS. Is there a case for DHEA replacement? Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):507-20. doi: 10.1016/s0950-351x(98)80286-3.
Jankowski CM, Gozansky WS, Schwartz RS, Dahl DJ, Kittelson JM, Scott SM, Van Pelt RE, Kohrt WM. Effects of dehydroepiandrosterone replacement therapy on bone mineral density in older adults: a randomized, controlled trial. J Clin Endocrinol Metab. 2006 Aug;91(8):2986-93. doi: 10.1210/jc.2005-2484. Epub 2006 May 30.
Jankowski CM, Gozansky WS, Kittelson JM, Van Pelt RE, Schwartz RS, Kohrt WM. Increases in bone mineral density in response to oral dehydroepiandrosterone replacement in older adults appear to be mediated by serum estrogens. J Clin Endocrinol Metab. 2008 Dec;93(12):4767-73. doi: 10.1210/jc.2007-2614. Epub 2008 Sep 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AG018857
Identifier Type: -
Identifier Source: secondary_id
AG0019
Identifier Type: -
Identifier Source: org_study_id