Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment - Full Text View

Purpose

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	Intervention	Phase
Adrenal Gland Hypofunction	Procedure: adrenal insufficiency testing Drug: prednisone	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Addison Disease Steroids

Drug Information available for: Dexamethasone Epinephrine bitartrate Epinephrine Prednisone Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Dexamethasone acetate Dexamethasone sodium phosphate

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

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. [ Time Frame: 7th day after stopping prednisone intake ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	May 2009
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975078

Locations

Switzerland
Division of Endocrinology University Hospital Basel
Basel, Switzerland, 4053

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Mirjam Christ-Crain, Professor

Division of Endocrinology University Hospital Basel

More Information

No publications provided

Responsible Party:	Mirjam Christ-Crain, Endocrinology, University Hospital Basel
ClinicalTrials.gov Identifier:	NCT00975078 History of Changes
Other Study ID Numbers:	DEXA
Study First Received:	September 7, 2009
Last Updated:	August 8, 2011
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

dexamethasone-suppression-test
high dose glucocorticoid treatment
Population at Risk

Additional relevant MeSH terms:

Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Epinephrine
Epinephryl borate
Dexamethasone
Dexamethasone acetate
Prednisone
Dexamethasone 21-phosphate
BB 1101
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on June 18, 2013