Addison SyndromeNCT00442390
Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure
A study testing hydrocortisone substitution therapy versus withdrawal in people with Addison Syndrome, run by University of Aarhus.
Trial summary
Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Addison Syndrome
- What is being tested?
- hydrocortisone substitution therapy versus withdrawal
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2003
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female adrenal failure
- Age 18-50
- Written informed content
Who cannot join
- Diabetes mellitus
- Cancer
- Thromboembolic events
- Pregnancy and lactation
- Heart disease
About this study
Official title: Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.
Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.
- Conditions
- Addison Syndrome
- Being tested
- hydrocortisone substitution therapy versus withdrawal
- Keywords
- Cortisol, adrenal insufficiency, glucose metabolism, protein metabolism, lipid metabolism, insulin sensitivity.
- Medical subject headings
- Adrenal Insufficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone substitution therapy versus withdrawalDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
local protein turnover
whole body protein turnover
glucose metabolism
serum metabolites
serum hormone levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Juel Christiansen, PhD, Principal investigator, University of AarhusClaus H Gravholt, MD, Study chair, University of AarhusChristian B Djurhuus, PhD, Study chair, University of AarhusPer Iversen, PhD, Study chair, University of AarhusJens S Christiansen, Professor, Study chair, University of AarhusOle Schmidt, Professor, Study chair, University of AarhusJørgen Weeke, Professor, Study chair, University of AarhusJens OL Jørgensen, MD, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442390
- Sponsor's protocol ID
- 1998/4375
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.
- ClinicalTrials.gov ID
- NCT00442390
- Acronym / sponsor ID
- 1998/4375
- Conditions
- Addison Syndrome
- Keywords
- Cortisol, adrenal insufficiency, glucose metabolism, protein metabolism, lipid metabolism, insulin sensitivity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jan 2003
- First posted
- 1 Mar 2007 (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.
Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female adrenal failure
- Age 18-50
- Written informed content
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Cancer
- Thromboembolic events
- Pregnancy and lactation
- Heart disease
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 |
|---|---|---|
| hydrocortisone substitution therapy versus withdrawal | Drug | – |
Primary outcome
insulin sensitivity
local protein turnover
whole body protein turnover
glucose metabolism
serum metabolites
serum hormone levels
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 1 Mar 2007.
Related trials for Addison Syndrome
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Cushing Syndrome, Adrenal Insufficiency
RecruitingObservational study
Natural History of Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Sphingosine Phosphate Lyase Insufficiency Syndrome (SPLIS)
Recruiting
Telehealth Music Therapy for Adults With Endocrine Disorder and Depression
Type 1 Diabetes, Hashimoto Disease
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.
Jens Juel Christiansen, PhD principal investigator
University of Aarhus
Claus H Gravholt, MD study chair
University of Aarhus
Christian B Djurhuus, PhD study chair
University of Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing hydrocortisone substitution therapy versus withdrawal in people with Addison Syndrome, run by University of Aarhus.
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 3 inclusion and 5 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 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
insulin sensitivity. The study lists 6 primary outcomes in all. 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 1 Mar 2007.