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


- candidate number21664
- NTR NumberNTR4966
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2015
- Secondary IDsNL49307.042.14 
- Public TitleRecovery of hypothalamic-pituitary-adrenal axis during glucocorticoid tapering in ANCA- associated vasculitis, a pilot study.
- Scientific TitleRecovery of circadian rhythm of the hypothalamic-pituitary-adrenal axis during glucocorticoid tapering in ANCA- associated vasculitis, a pilot study.
- ACRONYMCURVE
- hypothesisRecovery of the HPA axis shows interindividual differences. Recovery can be monitored using saliva sampling and monitoring could prevent complaints during tapering of glucocorticoids.
- Healt Condition(s) or Problem(s) studiedANCA associated vasculitis, Glucocorticoid tapering , Hypothalamic-pituitary-adrenal axis
- Inclusion criteriaPatient 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 criteriaAge < 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate1-dec-2016
- Target number of participants30
- InterventionsNo intervention is planned. Participants will sample saliva during a standard glucocorticoid tapering regime.
- Primary outcomeThe main study endpoint is change in peak cortisol levels at acrophase during a glucocorticoid tapering regime
- Secondary outcomeSecondary 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 glucocorticoidinduced adrenal insufficiency, quality of life, fatigue and sleep quality.
- TimepointsThe 24-hour sampling will take place at prednisolone dosages of 10 mg (T1 =2 weeks), 7,5 mg (T2= 2 weeks), 5 mg (T3= 6 weeks), 2,5 mg (T4= 8 weeks) and 4 weeks (T5= 12 weeks) and 3 months after stop of the glucocorticoids (T6= 20 weeks)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Janneke Tuin
- CONTACT for SCIENTIFIC QUERIES Janneke Tuin
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryGlucocorticoids are extensively used for a wide-variety of diseases. In many diseases, amongst others rheumatic diseases, high-dose glucocorticoids are administered to control disease activity. These supra-physiological glucocorticoid doses suppress the endogenous cortisol production and disrupt the circadian rhythm of the hypothalamic-pituitary-adrenal (HPA) axis. In order to prevent relapses and to give the adrenal glands time to recover the endogenous cortisol production, tapering regimes are used for glucocorticoid withdrawal. However, no longitudinal studies have investigated the effect of a tapering regime on the recovery of the circadian rhythm of the HPA axis and the relation with complaints possibly compatible with secondary adrenal insufficiency. The primary aim of this study is to investigate the recovery of the circadian rhythm of the hypothalamic-pituitary-adrenal axis during a glucocorticoid tapering regime. Secondary objectives include the effect of a tapering regime on melatonin rhythm, cytokine profile, complaints compatible with secondary glucocorticoid-induced adrenal insufficiency and quality of life, fatigue and sleep quality
- Main changes (audit trail)
- RECORD8-feb-2015 - 4-aug-2015


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