Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
Primary Purpose
Adrenal Gland Hypofunction
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
adrenal insufficiency testing
prednisone
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Gland Hypofunction focused on measuring dexamethasone-suppression-test, high dose glucocorticoid treatment, Population at Risk
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteers over 18 years
Exclusion Criteria:
- No informed consent
- Intake of any kind of medication
- BMI over 30kg/m2
- Acute or chronic illnesses
Sites / Locations
- Division of Endocrinology University Hospital Basel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adrenal insufficiency
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00975078
First Posted
September 7, 2009
Last Updated
August 8, 2011
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00975078
Brief Title
Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
Official Title
Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The objective of this study is to evaluate if adrenal axis integrity investigated by the dexamethasone-suppression-test will predict the development of adrenal insufficiency after 14 days treatment with 0.5mg/kg of body weight prednisone in healthy volunteers. The investigators hypothesize that subjects with a more suppressed cortisol level after dexamethasone will be more likely to develop adrenal insufficiency after 14 days intake of prednisone o.5mg/kg/body weight than subjects with less suppression of their cortisol levels after dexamethasone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Gland Hypofunction
Keywords
dexamethasone-suppression-test, high dose glucocorticoid treatment, Population at Risk
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adrenal insufficiency
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
adrenal insufficiency testing
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
0.5mg/kg body-weight prednisone each morning for 14 days
Primary Outcome Measure Information:
Title
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.
Time Frame
7th day after stopping prednisone intake
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteers over 18 years
Exclusion Criteria:
No informed consent
Intake of any kind of medication
BMI over 30kg/m2
Acute or chronic illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Professor
Organizational Affiliation
Division of Endocrinology University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology University Hospital Basel
City
Basel
ZIP/Postal Code
4053
Country
Switzerland
12. IPD Sharing Statement
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Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
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