Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Adrenal Gland Hypofunction

Treatments: Drug: prednisone; Procedure: adrenal insufficiency testing

Study type: Interventional

Funder types: Other

Identifiers

NCT00975078

DEXA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

adrenal insufficiency

Experimental group

Treatment:

Drug: prednisone

Procedure: adrenal insufficiency testing