DHEA Replacement in Adrenalectomized/Hypoadrenal Patients

NCT ID: NCT00279929

Last Updated: 2011-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2007-06-30

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.

Conditions

Aging; Dehydroepiandosterone Replacement; DHEA Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DHEA Replacement

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Principal Investigators

K. Sreekumaran Nair, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Dhatariya KK, Greenlund LJ, Bigelow ML, Thapa P, Oberg AL, Ford GC, Schimke JM, Nair KS. Dehydroepiandrosterone replacement therapy in hypoadrenal women: protein anabolism and skeletal muscle function. Mayo Clin Proc. 2008 Nov;83(11):1218-25. doi: 10.4065/83.11.1218.

Reference Type: DERIVED

PMID: 18990320 (View on PubMed)

Other Identifiers

P01AG014383

Identifier Type: NIH

Identifier Source: secondary_id

View Link

669-02

Identifier Type: -

Identifier Source: org_study_id