Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

NCT00099697 | Completed

• 7 other identifiers: AG00135P60AG0136295R01AG0200765K23RR0161913P30DK0563415P60DK0205792M01RR000036
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.

Conditions

Aging; Obesity; Insulin Resistance

Keywords

abdominal fat; dehydroepiandrosterone; Insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• 6-month change in visceral and subcutaneous abdominal fat

Interventions

DHEA DRUG

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
• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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: 9374813 BACKGROUND

• 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. doi: 10.1093/gerona/53a.1.b19.

  PMID: 9467418 BACKGROUND

• 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, 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

Conditions

Obesity; Insulin Resistance

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

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

Study Officials

• John O. Holloszy, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Dennis T. Villareal, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 17, 2004
• First Posted: December 20, 2004
• Study Start: June 1, 2001
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: December 11, 2009

Record last verified: 2004-12

Locations

US (1)