Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers
1 other identifier
interventional
39
1 country
1
Brief Summary
Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 7, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 9, 2011
August 1, 2011
5 months
September 7, 2009
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of this study is the rate of adrenal insufficiency assessed on the 7th day after stopping a 14-days course of corticosteroid therapy with 0.5mg/kg KG prednisone per day.
7th day after stopping prednisone intake
Study Arms (1)
adrenal insufficiency
EXPERIMENTALInterventions
On the day getting the baseline data we will perform a low dose cosyntropin test to asses adrenal axis function. All participants will then undergo an overnight 0.5mg dexamethasone suppression test. Thereby participants will take 0.5mg of dexamethasone at 11 pm and a fasting blood sample will be collected the next morning at 8 am to measure the serum cortisol level. Six days later participants will start taking 0.5mg/kg body-weight prednisone each morning for 14 days. On day 1, 3, 7 and 21 after withdrawal of prednisone the participant will undergo a low dose cosyntropin test. The investigators will take a blood sample before and 30 minutes after i.v. administration of 1ug of cosyntropin for the measurement of cortisol.
Eligibility Criteria
You may qualify if:
- Healthy male volunteers over 18 years
You may not qualify if:
- No informed consent
- Intake of any kind of medication
- BMI over 30kg/m2
- Acute or chronic illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Endocrinology University Hospital Basel
Basel, Basel, 4053, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirjam Christ-Crain, Professor
Division of Endocrinology University Hospital Basel
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2009
First Posted
September 11, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 9, 2011
Record last verified: 2011-08