Adrenal Gland HypofunctionPhase 4NCT00975078
Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
A Phase 4 study testing adrenal insufficiency testing and prednisone in people with Adrenal Gland Hypofunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adrenal Gland Hypofunction
- What is being tested?
- adrenal insufficiency testing and prednisone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2009to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers over 18 years
Who cannot join
- No informed consent
- Intake of any kind of medication
- BMI over 30kg/m2
- Acute or chronic illnesses
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Endocrinology University Hospital Basel
Basel, Basel, 4053
About this study
Official title: Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers
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.
Read the 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.
- Conditions
- Adrenal Gland Hypofunction
- Being tested
- adrenal insufficiency testing, prednisone
- Keywords
- dexamethasone-suppression-test, high dose glucocorticoid treatment, Population at Risk
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adrenal insufficiency testingProcedure or surgery
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.
prednisoneDrug
0.5mg/kg body-weight prednisone each morning for 14 days
| Study group | Role | What they receive |
|---|---|---|
| adrenal insufficiency | Experimental | Not described Receives: Procedure: adrenal insufficiency testing; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7th day after stopping prednisone intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Gland HypofunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Mirjam Christ-Crain, Professor, Principal investigator, Division of Endocrinology University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975078
- Sponsor's protocol ID
- DEXA
- Status last verified
- Aug 2011
- First submitted
- 7 Sep 2009
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00975078
- Acronym / sponsor ID
- DEXA
- Conditions
- Adrenal Gland Hypofunction
- Keywords
- dexamethasone-suppression-test, high dose glucocorticoid treatment, Population at Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adrenal insufficiency | Experimental | Procedure: adrenal insufficiency testing, Drug: prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male volunteers over 18 years
Key exclusion criteria (4 listed)
- No informed consent
- Intake of any kind of medication
- BMI over 30kg/m2
- Acute or chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adrenal insufficiency testingOn 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. | Procedure or surgery | adrenal insufficiency |
| prednisone0.5mg/kg body-weight prednisone each morning for 14 days | Drug | adrenal insufficiency |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, Professor principal investigator
Division of Endocrinology University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adrenal insufficiency testing and prednisone in people with Adrenal Gland Hypofunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.