NCT00279929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

January 18, 2006

Last Update Submit

May 20, 2011

Conditions

AgingDehydroepiandosterone ReplacementDHEA Replacement

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

DHEA ReplacementPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 18990320DERIVED

Study Officials

  • K. Sreekumaran Nair, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

July 1, 2002

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

US(1)