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Completed

NCT Number: NCT00279929

DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DHEA Replacement

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jan 20, 2006
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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