Effects of Dehydroepiandrosterone (DHEA) in Humans
Is DHEA Replacement Beneficial?
2 other identifiers
interventional
142
1 country
1
Brief Summary
The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2002
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedAugust 25, 2008
August 1, 2008
5 years
September 13, 2005
August 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength
Secondary Outcomes (1)
bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)
Interventions
Eligibility Criteria
You may qualify if:
- to 75 years old
- Physically healthy
- Non-smoker
- On stable medications for at least 6 months
- Stable body weight for the past year
You may not qualify if:
- Serious active medical problems
- Hormone therapy
- Abnormal PSA (prostate specific antigen) in men
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63131, United States
Related Publications (4)
Hansen PA, Han DH, Nolte LA, Chen M, Holloszy JO. DHEA protects against visceral obesity and muscle insulin resistance in rats fed a high-fat diet. Am J Physiol. 1997 Nov;273(5):R1704-8. doi: 10.1152/ajpregu.1997.273.5.R1704.
PMID: 9374813BACKGROUNDHan DH, Hansen PA, Chen MM, Holloszy JO. DHEA treatment reduces fat accumulation and protects against insulin resistance in male rats. J Gerontol A Biol Sci Med Sci. 1998 Jan;53(1):B19-24. doi: 10.1093/gerona/53a.1.b19.
PMID: 9467418BACKGROUNDVillareal DT, Holloszy JO, Kohrt WM. Effects of DHEA replacement on bone mineral density and body composition in elderly women and men. Clin Endocrinol (Oxf). 2000 Nov;53(5):561-8. doi: 10.1046/j.1365-2265.2000.01131.x.
PMID: 11106916BACKGROUNDWeiss EP, Shah K, Fontana L, Lambert CP, Holloszy JO, Villareal DT. Dehydroepiandrosterone replacement therapy in older adults: 1- and 2-y effects on bone. Am J Clin Nutr. 2009 May;89(5):1459-67. doi: 10.3945/ajcn.2008.27265. Epub 2009 Mar 25.
PMID: 19321570DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John O. Holloszy, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
September 1, 2002
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
August 25, 2008
Record last verified: 2008-08