A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT03210545
• Date of registration: 29/06/2017
• Prospective Registration: Yes
• Primary sponsor: Göteborg University
• Public title: A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)
• Scientific title: A Dose-response Study of Markers of Glucocorticoid Effects (DOSCORT): A Double-blinded, Randomized, 2-dose, Cross-over Study
• Date of first enrolment: March 2, 2021
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03210545
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Sweden

Contacts

• Name: Johanna Mc Queen, MD

• Name: Johanna Mc Queen, MD

• Name: Gudmundur Johannsson, Prof., MD
• Affiliation: Vastra Gotaland Region, Sahlgrenska University Hospital, dept. of Endocrinology

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females at ages 20-65 years

2. Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency
due to autoimmune adrenalitis, i.e. Addison´s disease

3. A stable daily glucocorticoid replacement dose for at least 3 months prior to study
entry

4. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose

5. If needed, a stable fludrocortisone replacement dose for at least 3 months prior to
study entry

6. Body mass index (BMI) of 20-35 kg/m2

7. Ability to comply to the protocol procedures and having signed informed consent to
participate in the study

Exclusion Criteria:

1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere
with the study assessment of completion of the study

2. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L

3. Pregnant or lactating women

4. Diabetes Mellitus

5. Systemic infections

6. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks

7. Any medication with agents which in the investigators judgement might interfere with
the study drugs kinetics, including therapies affecting gastro intestinal emptying or
motility

8. Alcohol/drug abuse or any other condition associated with poor patient compliance,
including expected non-cooperation, as judged by the investigator

9. Hypersensitivity to the active substance or any excipients used in the study drug of
choice

10. Any additional underlying disease that may need regular or periodic pharmacological
treatment with glucocorticoids during the trail, such as asthma, skin- or eye
conditions treated with inhaled or topical glucocorticoids

11. Any additional underlying condition that needs treatment with intramuscular or
intra-articular steroid injections during the trial



Age minimum: 20 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Addison Disease

Intervention(s)

Drug: Betamethasone

Primary Outcome(s)

Metabolite profile changes between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone]

Protein profile changes between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone]

Secondary Outcome(s)

Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Functional Outcomes of Sleep Questionnaire (FOSQ). [Time Frame: Changes in units in the FOSQ (units on a scale) after 7 days of treatment with two different doses of betamethasone]

Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Psychological General Well-being (PGWB) index. [Time Frame: Changes in units of the PGWB index (units on a scale) after 7 days of treatment with two different doses of dexamethasone]

Changes in glucose metabolism between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in glucose metabolism (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone]

Changes in bone-markers between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in levels of bone-markers in blood (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone]

Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Fatigue impact scale (FIS) [Time Frame: Changes in units in the FIS (units on a scale) after 7 days of treatment with two different doses of betamethasone]

Changes in sleep quality between physiological and supra physiological doses of betamethasone [Time Frame: Changes in sleep quality (measurements and units provided in connected software) after 7 days of treatment with two different doses of betamethasone]

Changes in lipid-profile between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in lipid-profile (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone]

Changes in daily physical activity between physiological and supra physiological doses of betamethasone [Time Frame: Changes in daily physical activity (units provided in connected software) after 7 days of treatment with two different doses of betamethasone]

Messenger RNA (mRNA)/miRNA profile changes between physiological and supra physiological doses of betamethasone. [Time Frame: Changes in mRNA/miRNA (Svedberg Unit, S) during 7 days of treatment with two different doses of betamethasone]

Changes in self-reported Quality of Life between physiological and supra physiological doses of betamethasone using the Addison-specific Quality of Life questionnaire (ADDIQoL). [Time Frame: Changes in units of the ADDIQoL questionnaire (units on a scale) after 7 days of treatment with two different doses of betamethasone]

Secondary ID(s)

DOSCORT

2016-004078-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors