DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

Not Applicable

Completed

• Conditions: Aging; Dehydroepiandosterone Replacement; DHEA Replacement

• Registration Number: NCT00279929
• Lead Sponsor: Mayo Clinic

Brief Summary

The role of dehydroepiandosterone (DHEA) and its sulphated ester (DHEAS) \[together known as DHEA(S)\] in humans remains to be fully elucidated. They are the most abundant circulating steroid hormones in humans with the principle source of production being the adrenal glands. In adrenalectomised or hypoadrenal subjects it is not standard clinical practice to replace this hormone. Whilst this lack of DHEA(S) is clearly not life threatening, the published literature on the psychological effects of replacement in this population has shown some benefit in quality of life but data concerning the metabolic effects is conflicting and incomplete. We wish to carry out a study to measure the effect of DHEA(S) replacement in a group of adrenalectomised / hypoadrenal subjects and measure the outcome of a number of psychological and metabolic parameters both prior to and after twelve weeks of 50 mg/day DHEA(S) in a double blind randomised cross over design.

Mood, quality of life and sexual well being will be assessed using validated questionnaires. In addition, we will utilise the GCRC facility to measure body composition using total body water and DEXA. We will measure insulin sensitivity, exercise performance, muscle fatigability and VO2 max. Pre- and post- intervention muscle biopsies will assess DHEA(S) effects on myosin heavy chain isoform expression; skeletal muscle mitochondrial ATP production and be used to assess muscle enzyme levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
quality of life
glucose and insulin metabolism
muscle protein synthesis
body composition

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States