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Register:	ClinicalTrials.gov
Last refreshed on:	11 December 2023
Main ID:	NCT03793114
Date of registration:	06/11/2018
Prospective Registration:	No
Primary sponsor:	University of Bergen
Public title:	Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease
Scientific title:	Residual Secretion of Adrenal Steroid Hormones in Addison's Disease
Date of first enrolment:	September 26, 2018
Target sample size:	200
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03793114
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Germany	Norway	Sweden

Contacts

Name:	Eystein S Husebye, M.D, Prof
Address:
Telephone:
Email:
Affiliation:	University of Bergen

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Adrenal Insufficiency

Intervention(s)

Diagnostic Test: Baseline blood tests

Diagnostic Test: Cosyntropin stimulation test

Other: Blood test

Device: 30-hour ambulatory sampling of intestinal fluid

Primary Outcome(s)

The percentage of included patients with residual secretion of cortisol and aldosterone. [Time Frame: 1 day]

Secondary Outcome(s)

Medication-fasting ACTH-stimulated levels of cortisol precursors [Time Frame: 1 day]

Medication-fasting adrenocorticotropic hormone (ACTH)-stimulated levels of metanephrines [Time Frame: 1 day]

Medication-fasting basal levels of cortisol metabolites [Time Frame: 1 day]

Medication-fasting basal levels of cortisol precursors [Time Frame: 1 day]

Medication-fasting basal levels of renin in patients with and without residual function. [Time Frame: 1 day]

Medication-fasting ACTH-stimulated levels of aldosterone [Time Frame: 1 day]

Cortisol stress doses in patients with and without residual function. [Time Frame: 1 day]

Cortisol replacement doses, including 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]

Medication-fasting ACTH-stimulated levels of cortisol metabolites [Time Frame: 1 day]

Medication-fasting basal levels of metanephrines in patients with and without residual function [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]

Medication-fasting ACTH-stimulated levels of aldosterone metabolites [Time Frame: 1 day]

Medication-fasting ACTH-stimulated levels of cortisol [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 aldosterone [Time Frame: 1 day]

Medication-fasting basal levels of cortisol [Time Frame: 1 day]

Medication-fasting basal levels of aldosterone metabolites [Time Frame: 1 day]

Medication-fasting basal levels of aldosterone precursors [Time Frame: 1 day]

Medication-fasting ACTH-stimulated levels of aldosterone precursors [Time Frame: 1 day]

Number of adrenal crises pr. 100 patient years [Time Frame: 1 day]

Secondary ID(s)

2018/751/REK sør-øst A (REK)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Charite University, Berlin, Germany

Karolinska Institutet

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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