A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT) (NCT03210545) | Clinical Trial Compass
CompletedPhase 4
A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)
Sweden30 participantsStarted 2021-03-02
Plain-language summary
DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males and females at ages 20-65 years
✓. Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
✓. A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
✓. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
✓. If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
✓. Body mass index (BMI) of 20-35 kg/m2
✓. Ability to comply to the protocol procedures and having signed informed consent to participate in the study
Exclusion criteria
✕. 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
✕
What they're measuring
1
Protein profile changes between physiological and supra physiological doses of betamethasone.
Timeframe: Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone
2
Metabolite profile changes between physiological and supra physiological doses of betamethasone.
Timeframe: Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone
. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
✕. Pregnant or lactating women
✕. Diabetes Mellitus
✕. Systemic infections
✕. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
✕. Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
✕. Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator