Effects of Dehydroepiandrosterone (DHEA) in Humans - Full Text View

Purpose

The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.

Condition	Intervention	Phase
Aging	Drug: DHEA replacement	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Is DHEA Replacement Beneficial?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

U.S. FDA Resources

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

Primary Outcome Measures:

body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength

Secondary Outcome Measures:

bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)

Enrollment:	142
Study Start Date:	September 2002
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Detailed Description:

DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also appears to have anabolic effects on muscle and bone. The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being.

The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will (a) Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve general sense of well being.

Eligibility

Ages Eligible for Study:	65 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

65 to 75 years old
Physically healthy
Non-smoker
On stable medications for at least 6 months
Stable body weight for the past year

Exclusion Criteria:

Serious active medical problems
Hormone therapy
Abnormal PSA (prostate specific antigen) in men

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182975

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63131

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

John O. Holloszy, MD

Washington University School of Medicine

More Information

Publications:

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 Pt 2):R1704-8.

Han 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.

Villareal 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weiss 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. Epub 2009 Mar 25.

ClinicalTrials.gov Identifier:	NCT00182975 History of Changes
Other Study ID Numbers:	AG0047, R01AG020076
Study First Received:	September 13, 2005
Last Updated:	August 21, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Metabolic syndrome

Additional relevant MeSH terms:

Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013