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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004078-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| betamethasone - physiological dose | Active Comparator | Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated physiological dose during one treatment period. |
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| betamethasone - supra physiological dose | Active Comparator | Replacing participants hydrocortisone with a daily dose of betamethasone in an estimated supra physiological dose during one treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Protein profile changes between physiological and supra physiological doses of betamethasone. | By using mas spectrometry, protein profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. | Changes in proteome (g/dl or umol/l) during 7 days of treatment with two different doses of betamethasone |
| Metabolite profile changes between physiological and supra physiological doses of betamethasone. | By using mas spectrometry, metabolite profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. | Changes in metabolome (units depending on the kind of metabolome) during 7 days of treatment with two different doses of betamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Messenger RNA (mRNA)/miRNA profile changes between physiological and supra physiological doses of betamethasone. | By using array based transcriptomics (both mRNA and miRNA), mRNA/miRNA profile changes in blood, urine and saliva will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gudmundur Johannsson, Prof., MD | Vastra Gotaland Region, Sahlgrenska University Hospital, dept. of Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital | Gothenburg | 413 45 | Sweden |
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| ID | Term |
|---|---|
| D000224 | Addison Disease |
| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Double-blinded
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| Changes in mRNA/miRNA (Svedberg Unit, S) during 7 days of treatment with two different doses of betamethasone |
| Changes in glucose metabolism between physiological and supra physiological doses of betamethasone. | Conventional markers for glucose metabolism in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. | Changes in glucose metabolism (units depending on sample analysis) during 7 days of treatment with two different doses of betamethasone |
| Changes in lipid-profile between physiological and supra physiological doses of betamethasone. | Conventional markers for lipid-profile in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. | Changes in lipid-profile (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. | Bone-markers in blood will be identified at four timepoints: after 3 hours and after 7 days during treatment with betamethasone in a physiological dose and after 3 hours and after 7 days during treatment with betamethasone in a supra physiological dose. | 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 between physiological and supra physiological doses of betamethasone using the Addison-specific Quality of Life questionnaire (ADDIQoL). | Self-reported health-related quality of life and general well-being will be assessed using the ADDIQoL questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone. | Changes in units of the ADDIQoL questionnaire (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. | Self-reported health-related quality of life and general well-being will be assessed using the PGWB index after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone. | Changes in units of the PGWB index (units on a scale) after 7 days of treatment with two different doses of dexamethasone |
| Changes in self-reported quality of life and fatigue between physiological and supra physiological doses of betamethasone using the Fatigue impact scale (FIS) | Self-reported health-related quality of Life, general well-being and fatigue will be assessed using the FIS questionnaire after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone. | Changes in units in the FIS (units on a scale) after 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 Functional Outcomes of Sleep Questionnaire (FOSQ). | Self-reported health-related quality of life, general well-being and fatigue will be assessed using FOSQ after 7 days of treatment with a physiological dose of betamethasone and after 7 days of treatment with a supra physiological dose of betamethasone. | Changes in units in the FOSQ (units on a scale) after 7 days of treatment with two different doses of betamethasone |
| Changes in daily physical activity between physiological and supra physiological doses of betamethasone | Daily physical activity will be objectively evaluated using a wrist accelerometer during 7 days of treatment with a physiological dose of betamethasone and during 7 days of treatment with a supra physiological dose of betamethasone. | Changes in daily physical activity (units provided in connected software) after 7 days of treatment with two different doses of betamethasone |
| Changes in sleep quality between physiological and supra physiological doses of betamethasone | Sleep quality will be objectively evaluated using a wrist worn sleep monitor during the last night of a 7 day treatment period with a physiological dose of betamethasone and the last night of a 7 day treatment period with a supra physiological dose of betamethasone. | Changes in sleep quality (measurements and units provided in connected software) after 7 days of treatment with two different doses of betamethasone |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |