Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

Phase 4

Completed

• Conditions: Adrenal Gland Hypofunction
• Interventions: Procedure: adrenal insufficiency testing; Drug: prednisone

• Registration Number: NCT00975078
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

• Healthy male volunteers over 18 years

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Exclusion Criteria

• No informed consent
• Intake of any kind of medication
• BMI over 30kg/m2
• Acute or chronic illnesses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adrenal insufficiency	adrenal insufficiency testing	-
adrenal insufficiency	prednisone	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Endocrinology University Hospital Basel; 🇨🇭 Basel, Switzerland