Trial record 14 of 84 for:    "Hypoadrenalism"

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00975078
First received: September 7, 2009
Last updated: August 8, 2011
Last verified: August 2011
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Adrenal Insufficiency
Addison Disease
Adrenal Gland Diseases
Autoimmune Diseases
Endocrine System Diseases
Immune System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Epinephrine
Epinephryl borate
Prednisone
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on October 22, 2014