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NCT Number: NCT00975078

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

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.

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Key information

Conditions

Adrenal Gland Hypofunction Adrenal Gland Diseases Adrenal Insufficiency Endocrine System Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Division of Endocrinology University Hospital Basel

Basel, 4053, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adrenal insufficiency testing

Procedure

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.

Prednisone

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2009
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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