Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00975078
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 9, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Adrenal Gland Hypofunction Procedure: adrenal insufficiency testing Drug: prednisone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers
Study Start Date : May 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: adrenal insufficiency Procedure: adrenal insufficiency testing

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.

Drug: prednisone
0.5mg/kg body-weight prednisone each morning for 14 days

Primary Outcome Measures :
  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. [ Time Frame: 7th day after stopping prednisone intake ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00975078

Division of Endocrinology University Hospital Basel
Basel, Switzerland, 4053
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Mirjam Christ-Crain, Professor Division of Endocrinology University Hospital Basel

Responsible Party: Mirjam Christ-Crain, Endocrinology, University Hospital Basel Identifier: NCT00975078     History of Changes
Other Study ID Numbers: DEXA
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Basel, Switzerland:
high dose glucocorticoid treatment
Population at Risk

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Epinephryl borate
Addison Disease
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents