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Completed

NCT Number: NCT00182975

Effects of Dehydroepiandrosterone (DHEA) in Humans

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

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Key information

Conditions

Aging Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington University School of Medicine

St Louis, Missouri, 63131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHEA replacement

Drug

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)

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

Is DHEA Replacement Beneficial?

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Aug 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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