Primary Adrenal InsufficiencyNCT03793114
Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease
A study testing Cosyntropin stimulation test, Baseline blood tests and 30-hour ambulatory sampling of intestinal fluid in people with Primary Adrenal Insufficiency, run by University of Bergen at 3 sites in 3 countries.
Trial summary
In autoimmune adrenal insufficiency, or Addison's disease (AD), the immune system attacks the adrenal cortex. As a result, the adrenal cells producing hormones such as cortisol and aldosterone are destroyed, leaving the body with insufficient levels to meet its needs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Adrenal Insufficiency
- What is being tested?
- Cosyntropin stimulation test, Baseline blood tests and 30-hour ambulatory sampling of intestinal fluid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Sep 2018to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with AAD, age 18-70 years old. This requires documented adrenal insufficiency and a positive test for 21-hydroxylase autoantibodies (biomarker for autoimmune cause) on at least one occasion.
- Provided written informed consent
- In case of concomitant endocrine/autoimmune diseases, the patients should be on stable adequate treatment at least the last 3 months prior to the study period.
- For Norwegian AD patients: enrolled in ROAS
- For Swedish AD patients: enrolled in the Swedish Addison registry
Who cannot join
- Antihypertensive treatment, with the exception of doxazosin, verapamil, and moxonidine.
- Active malignant disease, severe heart, kidney or liver failure.
- Diabetes mellitus type 1.
- Pregnancy or breast feeding.
- Pharmacological treatment with glucocorticoids (except their usual cortisone or hydrocortisone replacement therapy) or drugs that interfere with cortisol and catecholamine metabolism (antiepileptics, rifampicin, St. Johns wart).
- Use of other glucocorticoid replacement medication than cortisone acetate or hydrocortisone.
- Intake of grapefruit, grapefruit juice, or and liquorice juice the last week before or during the study period.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Residual Secretion of Adrenal Steroid Hormones in Addison's Disease
In autoimmune adrenal insufficiency, or Addison's disease (AD), the immune system attacks the adrenal cortex. As a result, the adrenal cells producing hormones such as cortisol and aldosterone are destroyed, leaving the body with insufficient levels to meet its needs. The common perception is that upon diagnosis of Addison's disease, basically all adrenal hormone production has ceased.
There have, however, been found a few individuals who preserve some residual secretion of cortisol even years after diagnosis. The objectives of this study is to find out how common it is, and to explore if residual function have impact on patient outcome. That is, do patients with and without residual function differ when it comes to quality of life, working ability, medication dosages, and risk of adrenal crisis?
Read the detailed description
Autoimmune destruction of the adrenal cortex is the main cause of primary adrenal insufficiency (Addison's disease, AD). Autoimmune AD (AAD) becomes clinically manifest when 90 % of cortex of adrenal gland is destroyed. Current dogma says that adrenal insufficiency ultimately is complete, that is the adrenal cortex stops producing steroids altogether. However, several case reports indicate that there might be a subgroup of patients that retain some steroid production, even years after the diagnosis. This ability could be beneficial as it could protect against adrenal crises, ease medication, and leave the patient with better quality of life.
The objective of the study is to systematically assess to what extent patients with AAD have residual adrenocortical function, and to characterize this subgroup.
The study will be an open non-randomized three-stage multicenter clinical trial comprising patients from the Norwegian Registry for organ-specific autoimmune disease (ROAS), the Swedish Addison registry, and Germany. In stage 1, patients will be asked to fill out questionnaires and deliver medication-fasting samples for analyses of adrenal steroids. In addition, patients with congenital adrenal hyperplasia (CAH) and bilaterally adrenalectomized will serve as negative controls for adrenal steroids. In stage 2, AAD patients with residual steroid production will be invited to a cosyntropin stimulation test to estimate the maximum steroid output from the adrenal glands. Twenty patients with no sign of residual function will also be tested as a control group. In stage 3, AAD patients with confirmed residual function will be invited to go through a 30-hour ambulatory sampling of interstitial fluid for investigation of diurnal variation in adrenocortical hormone levels. Also, newly diagnosed AAD patients will be invited to repeated cosyntropin testing as a means of delineating the natural progression of adrenocortical failure.
- Conditions
- Primary Adrenal Insufficiency
- Being tested
- Cosyntropin stimulation test, Baseline blood tests, 30-hour ambulatory sampling of intestinal fluid, Blood test
- Medical subject headings
- Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosyntropin stimulation testDiagnostic test
Also called Synacthen stimulation test
Blood samples are taken before (0 min), and 30 and 60 min after intravenously administration of 250 µg cosyntropin (tetracosactide acetate) with the patient placed in the recumbent position. The test will be performed non-fasting (but medication-fasting) between 08:00 and 10:00 a.m.
Baseline blood testsDiagnostic test
Medication-fasting morning levels of adrenocortical hormones.
30-hour ambulatory sampling of intestinal fluidDevice
30-hour ambulatory sampling of intestinal fluid for analysis of adrenocortical hormones.
Blood testOther
Cardiovascular and inflammatory biomarker profiles
| Study group | Role | What they receive |
|---|---|---|
| Detectable levels of adrenal hormones | Experimental | Patients with detectable serum levels of adrenal hormones will go through cosyntropin stimulation testing. Receives: Diagnostic Test: Cosyntropin stimulation test |
| Controls with undetectable hormone levels | Active comparator | Twenty patients without detectable serum levels of adrenal hormones will serve as controls in cosyntropin stimulation testing. Receives: Diagnostic Test: Cosyntropin stimulation test |
| Undetectable levels of adrenal hormones | No intervention | Patients without detectable serum levels of adrenal hormones. Cosyntropin stimulation testing will not be performed. |
| Congenital adrenal hyperplasia (CAH) control group | Other | Mapping adrenal steroid profile in patients with congenital adrenal hyperplasia (CAH) with confirmed total deficiency of 21-hydroxylase. Receives: Diagnostic Test: Baseline blood tests |
| Bilaterally adrenalectomized control group | Other | Mapping adrenal steroid profile in patients who are bilaterally adrenalectomized. Receives: Diagnostic Test: Baseline blood tests |
| Diurnal variation in residual adrenocortical hormone levels | Experimental | Patients with detectable serum levels of adrenal hormones will go through a 30-hour ambulatory sampling of interstitial fluid for mapping of any diurnal variation in endogenous adrenocortical secretion. Receives: Device: 30-hour ambulatory sampling of intestinal fluid |
| Repeated cosyntropin testing in newly diagnosed patients | Experimental | Newly diagnosed patients will be invited to go through repeated cosyntropin testing to delineate the natural progression of adrenocortical failure. Receives: Diagnostic Test: Cosyntropin stimulation test |
| Cardiovascular and inflammatory biomarkers | Active comparator | Compare cardiovascular and inflammatory biomarker profiles in patients with and without residual production of adrenocortical steroids Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of included patients with residual secretion of cortisol and aldosterone.
Percentage of included patients with detectable levels of adrenal steroid hormones.
Measured: 1 day
Secondary outcomes (34)
Medication-fasting adrenocorticotropic hormone (ACTH)-stimulated levels of metanephrines
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of cortisol
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of cortisol
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of cortisol
Levels in hair samples
Measured: 1 day
Medication-fasting basal levels of cortisol precursors
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of cortisol precursors
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of cortisol precursors
Levels in hair samples
Measured: 1 day
Medication-fasting basal levels of cortisol metabolites
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of cortisol metabolites
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of cortisol metabolites
Levels in hair samples
Measured: 1 day
Medication-fasting basal levels of aldosterone
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of aldosterone
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of aldosterone precursors
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of aldosterone precursors
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of aldosterone metabolites
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of aldosterone metabolites
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of renin in patients with and without residual function.
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of renin in patients with and without residual function.
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of ACTH in patients with and without residual function.
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of ACTH in patients with and without residual function.
Levels in urine samples
Measured: 1 day
Medication-fasting basal levels of metanephrines in patients with and without residual function
Levels in blood samples
Measured: 1 day
Medication-fasting basal levels of metanephrines in patients with and without residual function
Levels in urine samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of cortisol
Levels in blood samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of cortisol precursors
Levels in blood samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of cortisol metabolites
Levels in blood samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone
Levels in blood samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone precursors
Levels in blood samples
Measured: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone metabolites
Levels in blood samples
Measured: 1 day
Cortisol replacement doses, including stress doses in patients with and without residual function.
Total daily dosage
Measured: 1 day
Cortisol stress doses in patients with and without residual function.
No. stress doses the last week
Measured: 1 day
Fludrocortisone replacement doses in patients with and without residual function.
Total daily dosage.
Measured: 1 day
In patients with and without residual function: disease-specific quality-of-life
Total score ranging from 30 to 120 in disease-specific quality-of-life questionnaire, Addison Quality of Life (AddiQoL). For every question, scoring is translated in points (1 = 1 point, 2 and 3 = 2 points, 4 and 5 = 3 points, 6 = 4 points) and the algebraic sum of points is calculated. A higher score reflects better health-related quality-of-life.
Measured: 1 day
In patients with and without residual function, generic health-related quality of life by the Short Form (36) Health Survey
The Short Form (36) Health Survey is a generic tool comprising 36 items evaluating patient reported quality of life concerning eight domains (physical functioning, role functioning physical, bodily pain, general health perception, vitality, social functioning, role functioning emotional, and mental health and general perception of change in health). Scores are expressed on a 0-100 scale with higher scores associated with better quality of life. The result of each domain is presented separately.
Measured: 1 day
Number of adrenal crises pr. 100 patient years
Number of crises pr. 100 patient years for all included patients as well as in patients with versus without residual adrenal function
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start26 Sep 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Adrenal InsufficiencyStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Eystein S Husebye, M.D, Prof, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793114
- Sponsor's protocol ID
- 2018/751/REK sør-øst A (REK)
- Status last verified
- May 2026
- First submitted
- 6 Nov 2018
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon informed and signed content, biological samples will be stored in the biobank for research on endocrine disorders. Any new analyses will not be performed without approval from the Regional committee for medical and health research ethics.
Publications
Saevik AB, Akerman AK, Methlie P, Quinkler M, Jorgensen AP, Hoybye C, Debowska AJ, Nedrebo BG, Dahle AL, Carlsen S, Tomkowicz A, Sollid ST, Nermoen I, Gronning K, Dahlqvist P, Grimnes G, Skov J, Finnes T, Valland SF, Wahlberg J, Holte SE, Simunkova K, Kampe O, Husebye ES, Bensing S, Oksnes M. Residual Corticosteroid Production in Autoimmune Addison Disease. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2430-41. doi: 10.1210/clinem/dgaa256.
PubMed 32392298
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Secretion of Adrenal Steroid Hormones in Addison's Disease
- ClinicalTrials.gov ID
- NCT03793114
- Acronym / sponsor ID
- 2018/751/REK sør-øst A (REK)
- Conditions
- Primary Adrenal Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Charite University, Berlin, Germany
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jan 2019 (actual)
- 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.
In autoimmune adrenal insufficiency, or Addison's disease (AD), the immune system attacks the adrenal cortex. As a result, the adrenal cells producing hormones such as cortisol and aldosterone are destroyed, leaving the body with insufficient levels to meet its needs. The common perception is that upon diagnosis of Addison's disease, basically all adrenal hormone production has ceased.
There have, however, been found a few individuals who preserve some residual secretion of cortisol even years after diagnosis. The objectives of this study is to find out how common it is, and to explore if residual function have impact on patient outcome. That is, do patients with and without residual function differ when it comes to quality of life, working ability, medication dosages, and risk of adrenal crisis?
Detailed description
Autoimmune destruction of the adrenal cortex is the main cause of primary adrenal insufficiency (Addison's disease, AD). Autoimmune AD (AAD) becomes clinically manifest when 90 % of cortex of adrenal gland is destroyed. Current dogma says that adrenal insufficiency ultimately is complete, that is the adrenal cortex stops producing steroids altogether. However, several case reports indicate that there might be a subgroup of patients that retain some steroid production, even years after the diagnosis. This ability could be beneficial as it could protect against adrenal crises, ease medication, and leave the patient with better quality of life.
The objective of the study is to systematically assess to what extent patients with AAD have residual adrenocortical function, and to characterize this subgroup.
The study will be an open non-randomized three-stage multicenter clinical trial comprising patients from the Norwegian Registry for organ-specific autoimmune disease (ROAS), the Swedish Addison registry, and Germany. In stage 1, patients will be asked to fill out questionnaires and deliver medication-fasting samples for analyses of adrenal steroids. In addition, patients with congenital adrenal hyperplasia (CAH) and bilaterally adrenalectomized will serve as negative controls for adrenal steroids. In stage 2, AAD patients with residual steroid production will be invited to a cosyntropin stimulation test to estimate the maximum steroid output from the adrenal glands. Twenty patients with no sign of residual function will also be tested as a control group. In stage 3, AAD patients with confirmed residual function will be invited to go through a 30-hour ambulatory sampling of interstitial fluid for investigation of diurnal variation in adrenocortical hormone levels. Also, newly diagnosed AAD patients will be invited to repeated cosyntropin testing as a means of delineating the natural progression of adrenocortical failure.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Detectable levels of adrenal hormones | Experimental | Diagnostic Test: Cosyntropin stimulation testPatients with detectable serum levels of adrenal hormones will go through cosyntropin stimulation testing. |
| Controls with undetectable hormone levels | Active comparator | Diagnostic Test: Cosyntropin stimulation testTwenty patients without detectable serum levels of adrenal hormones will serve as controls in cosyntropin stimulation testing. |
| Undetectable levels of adrenal hormones | No intervention | –Patients without detectable serum levels of adrenal hormones. Cosyntropin stimulation testing will not be performed. |
| Congenital adrenal hyperplasia (CAH) control group | Other | Diagnostic Test: Baseline blood testsMapping adrenal steroid profile in patients with congenital adrenal hyperplasia (CAH) with confirmed total deficiency of 21-hydroxylase. |
| Bilaterally adrenalectomized control group | Other | Diagnostic Test: Baseline blood testsMapping adrenal steroid profile in patients who are bilaterally adrenalectomized. |
| Diurnal variation in residual adrenocortical hormone levels | Experimental | Device: 30-hour ambulatory sampling of intestinal fluidPatients with detectable serum levels of adrenal hormones will go through a 30-hour ambulatory sampling of interstitial fluid for mapping of any diurnal variation in endogenous adrenocortical secretion. |
| Repeated cosyntropin testing in newly diagnosed patients | Experimental | Diagnostic Test: Cosyntropin stimulation testNewly diagnosed patients will be invited to go through repeated cosyntropin testing to delineate the natural progression of adrenocortical failure. |
| Cardiovascular and inflammatory biomarkers | Active comparator | Other: Blood testCompare cardiovascular and inflammatory biomarker profiles in patients with and without residual production of adrenocortical steroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with AAD, age 18-70 years old. This requires documented adrenal insufficiency and a positive test for 21-hydroxylase autoantibodies (biomarker for autoimmune cause) on at least one occasion.
- Provided written informed consent
- In case of concomitant endocrine/autoimmune diseases, the patients should be on stable adequate treatment at least the last 3 months prior to the study period.
- For Norwegian AD patients: enrolled in ROAS
- For Swedish AD patients: enrolled in the Swedish Addison registry
Key exclusion criteria (7 listed)
- Antihypertensive treatment, with the exception of doxazosin, verapamil, and moxonidine.
- Active malignant disease, severe heart, kidney or liver failure.
- Diabetes mellitus type 1.
- Pregnancy or breast feeding.
- Pharmacological treatment with glucocorticoids (except their usual cortisone or hydrocortisone replacement therapy) or drugs that interfere with cortisol and catecholamine metabolism (antiepileptics, rifampicin, St. Johns wart).
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 |
|---|---|---|
| Cosyntropin stimulation testAlso: Synacthen stimulation testBlood samples are taken before (0 min), and 30 and 60 min after intravenously administration of 250 µg cosyntropin (tetracosactide acetate) with the patient placed in the recumbent position. The test will be performed non-fasting (but medication-fasting) between 08:00 and 10:00 a.m. | Diagnostic test | Controls with undetectable hormone levels, Detectable levels of adrenal hormones, Repeated cosyntropin testing in newly diagnosed patients |
| Baseline blood testsMedication-fasting morning levels of adrenocortical hormones. | Diagnostic test | Bilaterally adrenalectomized control group, Congenital adrenal hyperplasia (CAH) control group |
| 30-hour ambulatory sampling of intestinal fluid30-hour ambulatory sampling of intestinal fluid for analysis of adrenocortical hormones. | Device | Diurnal variation in residual adrenocortical hormone levels |
| Blood testCardiovascular and inflammatory biomarker profiles | Other | Cardiovascular and inflammatory biomarkers |
Primary outcome
The percentage of included patients with residual secretion of cortisol and aldosterone.
Time frame: 1 day
Percentage of included patients with detectable levels of adrenal steroid hormones.
34 secondary outcomes
Medication-fasting adrenocorticotropic hormone (ACTH)-stimulated levels of metanephrines
Time frame: 1 day
Medication-fasting basal levels of cortisol
Time frame: 1 day
Medication-fasting basal levels of cortisol
Time frame: 1 day
Medication-fasting basal levels of cortisol
Time frame: 1 day
Medication-fasting basal levels of cortisol precursors
Time frame: 1 day
Medication-fasting basal levels of cortisol precursors
Time frame: 1 day
Medication-fasting basal levels of cortisol precursors
Time frame: 1 day
Medication-fasting basal levels of cortisol metabolites
Time frame: 1 day
Medication-fasting basal levels of cortisol metabolites
Time frame: 1 day
Medication-fasting basal levels of cortisol metabolites
Time frame: 1 day
Medication-fasting basal levels of aldosterone
Time frame: 1 day
Medication-fasting basal levels of aldosterone
Time frame: 1 day
Medication-fasting basal levels of aldosterone precursors
Time frame: 1 day
Medication-fasting basal levels of aldosterone precursors
Time frame: 1 day
Medication-fasting basal levels of aldosterone metabolites
Time frame: 1 day
Medication-fasting basal levels of aldosterone metabolites
Time frame: 1 day
Medication-fasting basal levels of renin in patients with and without residual function.
Time frame: 1 day
Medication-fasting basal levels of renin in patients with and without residual function.
Time frame: 1 day
Medication-fasting basal levels of ACTH in patients with and without residual function.
Time frame: 1 day
Medication-fasting basal levels of ACTH in patients with and without residual function.
Time frame: 1 day
Medication-fasting basal levels of metanephrines in patients with and without residual function
Time frame: 1 day
Medication-fasting basal levels of metanephrines in patients with and without residual function
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of cortisol
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of cortisol precursors
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of cortisol metabolites
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone precursors
Time frame: 1 day
Medication-fasting ACTH-stimulated levels of aldosterone metabolites
Time frame: 1 day
Cortisol replacement doses, including stress doses in patients with and without residual function.
Time frame: 1 day
Cortisol stress doses in patients with and without residual function.
Time frame: 1 day
Fludrocortisone replacement doses in patients with and without residual function.
Time frame: 1 day
In patients with and without residual function: disease-specific quality-of-life
Time frame: 1 day
In patients with and without residual function, generic health-related quality of life by the Short Form (36) Health Survey
Time frame: 1 day
Number of adrenal crises pr. 100 patient years
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 32392298Saevik AB, Akerman AK, Methlie P, Quinkler M, Jorgensen AP, Hoybye C, Debowska AJ, Nedrebo BG, Dahle AL, Carlsen S, Tomkowicz A, Sollid ST, Nermoen I, Gronning K, Dahlqvist P, Grimnes G, Skov J, Finnes T, Valland SF, Wahlberg J, Holte SE, Simunkova K, Kampe O, Husebye ES, Bensing S, Oksnes M. Residual Corticosteroid Production in Autoimmune Addison Disease. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2430-41. doi: 10.1210/clinem/dgaa256.
- Individual participant dataSharing planned: No. Upon informed and signed content, biological samples will be stored in the biobank for research on endocrine disorders. Any new analyses will not be performed without approval from the Regional committee for medical and health research ethics.
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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.
Eystein S Husebye, M.D, Prof principal investigator
University of Bergen
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosyntropin stimulation test, Baseline blood tests and 30-hour ambulatory sampling of intestinal fluid in people with Primary Adrenal Insufficiency, run by University of Bergen at 3 sites in 3 countries.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Norway, Sweden. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 percentage of included patients with residual secretion of cortisol and aldosterone. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793114, which also lists 1 linked publication.
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 8 May 2026.