Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

Study Overview
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Brief Summary
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The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass).

Detailed Description
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The central hypothesis of this study is that restoring circulating levels of the adrenal hormone dehydroepiandrosterone (DHEA) in older people with low levels to more youthful levels will be associated with beneficial changes in lean mass, fat mass and bone mass. This will be a randomized, placebo-controlled, double-blinded study. Seventy-two men and 72 women, over 60 years old, who are healthy, will be randomized to receive either a replacement dose of DHEA or placebo for 1 year. The replacement dose of DHEA will bring circulating DHEA sulfate (DHEAS) levels into the range of normal in healthy 20-30 year-old women (approximately 8 micromoles per liter [μM] or 295 micrograms per deciliter [µg/dL]) and men (approximately 10 micromoles per liter [μM] or 368 micrograms per deciliter [µg/dL]). Fat mass and fat-free body mass will be evaluated by dual energy x-ray absorptiometry (DXA), and intra-abdominal fat volume and thigh muscle area will be measured by computed tomography (CT). Bone mineral density (BMD) of the total body, lumbar spine, and proximal femur will be measured by DXA and biochemical markers of bone resorption and formation. Glucose tolerance and insulin response will be evaluated using an oral glucose tolerance test. If this study confirms the results of a previous preliminary study, the current study is likely to impact future scientific study regarding the role of DHEA deficiency in the biology of aging and its role as a therapeutic agent for the prevention of sarcopenia.

Official Title
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Biological Effects of DHEA in the Elderly

Conditions
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Healthy

Intervention / Treatment
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* Drug: DHEA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women and men Age 60 or older Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old Exclusion Criteria: Contraindications to DHEA treatment (personal history of breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding in women, history or evidence of prostate cancer or benign prostatic hyperplasia (BPH) in men) Angina Resting blood pressure over 180/95 Chronic infections Hypothyroidism Depression Hormone therapy within the previous 6 months Insulin-dependent or poorly controlled diabetes Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL) Prohibited Medications: Hormone therapy other than stable regimen of thyroid replacement Oral glucocorticoids Insulin

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DHEA|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density |  |  | 
| body composition |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood lipids/lipoproteins |  |  | 
| glucose tolerance |  |  | 
| arterial compliance |  |  | 
| visceral adiposity |  |  | 
| quality of life |  |  | 
| sex steroids and growth factors |  |  | 
| sexual health |  |  | 
| cognitive function |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehydroepiandrosterone, DHEAS, bone mineral density, body composition, lean mass, fat mass, bone mass, decreased DHEAS levels