Adrenal insufficiency e.g. Addison´s disease
Conditions
Interventions
Trade Name: Betametason Evolan 0,5mg
Product Name: Betametason Evolan 0,5 mg tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: BETAMETHASONE
Other descriptive name: Betametason
Concentration uni
Sponsors
Sahlgrenska University Hospital, Gothenburg
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •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 •Hypersensitivity to the active substance or any excipients used in the study drug of choice •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 •Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a glucocorticoid dose response of potential biomarker(s), in blood and/or saliva and/or urine using omics analyses, in patients with Addison´s disease receiving alower physiological and a higher physiological glucocorticoid dose during 7 days each. ;Secondary Objective: To investigate a glucocorticoid dose response of 1. bone markers, lipid profile and glucose metabolism through blood sample analyses, 2. self-reported health-related quality of life and general well-being using validated questionnaires and 3. daily physical activity using a wrist warn accelerometer and sleep quality using and wrist warn sleep monitor in patients with Addison´s disease receiving a lower physiological and higher physiological glucocorticoid dose during 7 days each.;Primary end point(s): Difference in expression of the circulating plasma microRNA, miR-122, from baseline to end of treatment between the two doses of glucocortikoid (BMA). ;Timepoint(s) of evaluation of this end point: Baseline and after one week of treatment with a lower physiological glucocorticoid (BMA) dose (test week). Baseline and after one week of treatment with a higher physiological glucocorticoid (BMA) dose (test week). There will be a wash-out period of 2-5 weeks in between the two test-weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Difference in expression of other miRNAs, small metabolites, proteins and glucocorticoid metabolites in blood, saliva and urine from baseline to end of treatment between the two doses of BMA. •Difference in serum pro-collagen type 1 N-terminal pro-peptid (P1NP), carboxy-terminal collagen crosslinks (CTX), total-,LDL- and HDL-cholesterol, triglycerides, lipoprotein A and B, fp-glukos, f-serum-insulin and HbA1c from baseline to end of treatment between the two doses of BMA. •Difference in self reported quality of life and well-being based on validated questionnaires: Addison-specific quality-of-life (ADDIQoL), the Psychological General Well-Being (PGWB) index, the Fatigue Impact Scale (FIS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) between the two doses of BMA. •Difference in physical activity data generated from the wrist warn activity monitor ActiGraph GT3X and sleep data generated from WatchPATTM200U between the two doses of BMA. ;Timepoint(s) of evaluation of this end point: Questionnaires and blood sampling: • Baseline and end of treatment of the two treatment periods. Physical activity: • 24h/ day during the two treatment periods. Data collection at the end of each treatment period. Sleep quality: • The last two night of each treatment period. Data collection at the end of each treatment period. | — |
Countries
Sweden
Contacts
Public ContactDepartment of Endocrinology
Sahlgrenska University Hospital
Outcome results
None listed