DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

Aging Clinical Trial

Official title:

Assessing the Effects of Dehydroepiandrosterone Replacement on the Mood of Adrenalectomised/Hypoadrenal Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279929
• Other study ID #: 669-02
• Secondary ID: P01AG014383
• Status: Completed
• Phase: N/A
• First received: January 18, 2006
• Last updated: May 20, 2011
• Start date: July 2002
• Est. completion date: June 2007

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Subjects who have been adrenalectomised or have been hypoadrenal (from whatever cause) for > 24 months;

• Subjects who have been on a steady glucocorticoid replacement regime for >12 months;

• Women of child bearing age in whom oestrogen status has been steady for > 6 months - i.e. either on or off the oral contraceptive pill for that time;

• Subjects on other forms of hormone replacement therapy (e.g. thyroxin) in whom dose has remained the same for > 6 months.

Exclusion criteria:

• BMI >35 Kg/m2;

• Individuals with fasting blood glucose above 120mg/dl;

• A history of sex hormone dependant malignancy;

• A history of liver disease;

• Renal failure;

• Cardiovascular disease (other than hypertension);

• Polycythaemia;

• Pregnancy or breastfeeding;

• Cerebrovascular disorders;

• Neurological disorders;

• PSA levels above the age related reference range;

• Use of drugs known to alter mood within the 6 months prior to enrolment;

• Any drug known to affect hepatic biotransformation;

• Evidence of psychiatric disease or dementia;

• Postmenopausal women who have been on hormone replacement therapy for less than six months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Dehydroepiandosterone Replacement
• DHEA Replacement

Intervention

Procedure:
• DHEA Replacement

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension
Primary	quality of life
Primary	glucose and insulin metabolism
Primary	muscle protein synthesis
Primary	body composition