Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Dehydroepiandrosterone (DHEA) in Humans

NCT00182975

Aging

COMPLETED PHASE3

Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?

NCT00434915

Aging

COMPLETED NA

Effects of DHEA and Exercise in the Elderly

NCT00205686

Healthy Volunteers

COMPLETED PHASE3

DHEA and Testosterone Replacement in Elderly

NCT00254371

Aging Low DHEA for Women Low Testosterone and DHEA for Men

COMPLETED NA

DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

NCT00279929

Aging Dehydroepiandosterone Replacement DHEA Replacement

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DHEA

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes