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).
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
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.
- Healthy women and men
- Age 60 or older
- Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year
- 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)
- Resting blood pressure over 180/95
- Chronic infections
- Hormone therapy within the previous 6 months
- Insulin-dependent or poorly controlled diabetes
- Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL)
- Hormone therapy other than stable regimen of thyroid replacement
- Oral glucocorticoids