Recovery of hypothalamic-pituitary-adrenal axis during glucocorticoid tapering in ANCA- associated vasculitis, a pilot study.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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

Age < 18 years
Use of > 7,5 mg of glucocorticoids for more than 4 consecutive weeks within 6 months prior to diagnosis of disease or disease relapse.
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
Patients 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
Subject with 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study endpoint is change in peak cortisol levels at acrophase during a glucocorticoid tapering regime

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the effect on cortisol ratios or indices of cortisol production, which might prove to be helpful<br>in assessing adrenal function or might be suggestive for impaired recovery or adrenal insufficiency. Furthermore, the<br>effect of the tapering regime on melatonin rhythm, cytokine profile, complaints compatible with secondary glucocorticoidinduced<br>adrenal insufficiency, quality of life, fatigue and sleep quality.