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NCT00279929 · ClinicalTrials.gov registry record · NA
DHEA Replacement in Adrenalectomized/Hypoadrenal Patients
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT00279929: Completed NA study, sponsored by Mayo Clinic.
NCT00279929 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00279929, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE DHEA Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2002-07 |
| Est. Completion | 2007-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00279929
The ClinicalTrials.gov registry entry for NCT00279929 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DHEA Replacement is the first listed.
NCT00279929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00279929 about?
NCT00279929 is a clinical study titled "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 ...
What is the current status of trial NCT00279929?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2002-07. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00279929?
The interventions under investigation include: DHEA Replacement (PROCEDURE).
Who is sponsoring clinical trial NCT00279929?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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