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DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00279929
Collaborator
National Institutes of Health (NIH) (NIH), National Institute on Aging (NIA) (NIH)
32
Enrollment
1
Location
59
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: DHEA Replacement
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Assessing the Effects of Dehydroepiandrosterone Replacement on the Mood of Adrenalectomised/Hypoadrenal Subjects
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Outcome Measures

Primary Outcome Measures

  1. physical performance (VO2 peak, muscle strength as measured by chest press, double knee extension, and isokinetic knee extension []

  2. quality of life []

  3. glucose and insulin metabolism []

  4. muscle protein synthesis []

  5. body composition []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: K. Sreekumaran Nair, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00279929
Other Study ID Numbers:
  • 669-02
  • P01AG014383
First Posted:
Jan 20, 2006
Last Update Posted:
May 23, 2011
Last Verified:
May 1, 2011

Study Results

No Results Posted as of May 23, 2011