adrenal insufficiency secondary adrenal insufficiency
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient with newly diagnosed granulomatosis with polyangiitis or microscopic polyangiitis who received standard glucocorticoid induction protocol Patients with a relapse of granulomatosis with polyangiitis or microscopic polyangiitis who received standard glucocorticoid induction protocol Provide written informed consent
Exclusion criteria
Exclusion criteria: Applicable for patients and healthy controls Age 7,5 mg of glucocorticoids for more than 4 consecutive weeks within 6 months prior to study inclusion. Premenopausal women (because of effects of estrogens on cortisol binding globulin and because of differences in HPA axis functioning in the luteal or follicular phase) Postmenopausal women using oral contraceptives or estrogen replacement therapy (since estrogens increase the hepatic production of cortisol binding globulin) A history of endogenous hypocortisolism or hypercortisolism prior to this study Work in shifts or have a documented severely disturbed sleep pattern Not able to perform saliva sampling Persons who have a significant other medical condition (e.g. hepatic, respiratory, cardiovascular or gastrointestinal) which, in the opinion of the investigator, may interfere with the interpretation of results or efficacy evaluations Traveled through time zones with more than two hours time difference within the last month prior to this study Use of exogenous melatonin within the last 6 months prior to this study A documented depression Subjects who are in a stressful situation (for example, death of a relative), which in the opinion of the investigator, may interfere with the interpretation of results or efficacy evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is change in peak cortisol levels at acrophase during a glucocorticoid tapering regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the effect on cortisol ratios or indices of cortisol production, which might prove to be helpful in assessing adrenal function or might be suggestive for impaired recovery or adrenal insufficiency. Furthermore, the effect of the tapering regime on melatonin rhythm, cytokine profile, complaints compatible with secondary glucocorticoid-induced adrenal insufficiency, quality of life, fatigue and sleep quality. | — |
Countries
Netherlands
Outcome results
None listed