DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279929
First received: January 18, 2006
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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 Intervention
Aging
Dehydroepiandosterone Replacement
DHEA Replacement
Procedure: DHEA Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessing the Effects of Dehydroepiandrosterone Replacement on the Mood of Adrenalectomised/Hypoadrenal Subjects

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: July 2002
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00279929

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: K. Sreekumaran Nair, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00279929     History of Changes
Other Study ID Numbers: 669-02, P01 AG-14383
Study First Received: January 18, 2006
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014