Effects of DHEA and Exercise in the Elderly

NCT00205686 | Completed Phase 3

• 1 other identifier: K23RR016191
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds. The secretion of HDEA declines with aging. DHEA is considered a food supplement and it is not regulated by the FDA. The purpose of this research is to evaluate ceratin of the biological effects of a reaplcement dose of DHEA. As you get older, DHEA levels are lower than you were younger. The replamcent dose is the dose of DHEA that will raise DHEA levesl to the levels found in young people. Anotehr purpose is to determine whether DHEA enhances the adaptations to an exercise training program.

Conditions

Healthy Volunteers

Keywords

Aging, dhea, bone density, muscle mass, insulin action

Outcome Measures

Primary Outcomes (1)

• thigh muscle mass, muscle strength, intadominal fat, bone mineral density, markers of bone turnover, insulin sensitivity,

Secondary Outcomes (1)

• quality of life, vascular reactivity, levels of hormones

Interventions

DHEA DRUG

exercise BEHAVIORAL

Eligibility Criteria

• Age: 65 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• to 78 years old men and women

You may not qualify if:

• hormone therapy, history of hormone-dependent neoplasia, PSA above 2.6 ng/mL, or active serious illness, contraindications to exercise, dementia

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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. doi: 10.1046/j.1365-2265.2000.01131.x.

  PMID: 11106916 BACKGROUND

• Villareal DT. Effects of dehydroepiandrosterone on bone mineral density: what implications for therapy? Treat Endocrinol. 2002;1(6):349-57. doi: 10.2165/00024677-200201060-00001.

  PMID: 15832488 BACKGROUND

• 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.

  PMID: 15536111 RESULT

MeSH Terms

Interventions

Dehydroepiandrosterone; Exercise

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dennis T Villareal, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2001
• Study Completion: September 1, 2005
• Last Updated: January 6, 2006

Record last verified: 2005-09

Locations

US (1)