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 range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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