Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT03410160
Status:
UNKNOWN
Last Update Posted:
2019-10-14
First Post:
2018-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predisposing Factors for the Incidence of Adrenal Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Retention of samples with and without DNA (whole-blood and serum).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic inflammation (hsCRP, Interleukin-6)', 'timeFrame': '1 day', 'description': 'Measurement of hsCRP (mg/dl) and Interleukin-6 (pg/ml) levels. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit higher hsCRP and Interleukin-6 levels.'}, {'measure': 'Cortisol metabolism', 'timeFrame': '1 day', 'description': 'Measurement of cortisol-levels (mg/dl) before as well as 60 min and 120 min after ingestion of hydrocortisone. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit a faster hydrocortisone metabolism.'}, {'measure': 'Replacement therapy with glucocorticoids', 'timeFrame': '1 day', 'description': 'Evaluation of hormone replacement therapy with glucocorticoids by a clinical score. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.'}, {'measure': 'Replacement therapy with mineralocorticoids', 'timeFrame': '1 day', 'description': 'Evaluation of hormone replacement therapy with mineralocorticoids by a clinical and biochemical assessment. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.'}, {'measure': 'Glucocorticoid-receptor-polymorphisms', 'timeFrame': '1 day', 'description': 'Evaluation of glucocorticoid-receptor-polymorphisms (ER 22/23 EK, N363S, bcl1, 9beta, Tth3l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a higher prevalence of glucocorticoid-receptor-polymorphisms.'}, {'measure': 'Catecholamine-levels', 'timeFrame': '1 day', 'description': 'Evaluation of catecholamine-levels (ng/l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a more pronounced catecholamin-deficit.'}, {'measure': 'Patient education', 'timeFrame': '1 day', 'description': 'Evaluation of patient education by questionnaire. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a worse education status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adrenal crisis', 'predisposing factors'], 'conditions': ['Adrenal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '25419882', 'type': 'BACKGROUND', 'citation': 'Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.'}, {'pmid': '25288693', 'type': 'BACKGROUND', 'citation': 'Allolio B. Extensive expertise in endocrinology. Adrenal crisis. Eur J Endocrinol. 2015 Mar;172(3):R115-24. doi: 10.1530/EJE-14-0824. Epub 2014 Oct 6.'}, {'pmid': '22513882', 'type': 'BACKGROUND', 'citation': 'Reisch N, Willige M, Kohn D, Schwarz HP, Allolio B, Reincke M, Quinkler M, Hahner S, Beuschlein F. Frequency and causes of adrenal crises over lifetime in patients with 21-hydroxylase deficiency. Eur J Endocrinol. 2012 Jul;167(1):35-42. doi: 10.1530/EJE-12-0161. Epub 2012 Apr 18.'}, {'pmid': '25994948', 'type': 'BACKGROUND', 'citation': "Reincke M, Ritzel K, Osswald A, Berr C, Stalla G, Hallfeldt K, Reisch N, Schopohl J, Beuschlein F. A critical reappraisal of bilateral adrenalectomy for ACTH-dependent Cushing's syndrome. Eur J Endocrinol. 2015 Oct;173(4):M23-32. doi: 10.1530/EJE-15-0265. Epub 2015 May 20."}, {'pmid': '26208266', 'type': 'BACKGROUND', 'citation': 'Smans LC, Van der Valk ES, Hermus AR, Zelissen PM. Incidence of adrenal crisis in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2016 Jan;84(1):17-22. doi: 10.1111/cen.12865. Epub 2015 Aug 27.'}, {'pmid': '14689086', 'type': 'BACKGROUND', 'citation': 'Hahner S, Arlt W, Allolio B. [Adrenal crisis. Diagnostic and therapeutic management of acute adrenal cortex insufficiency]. Internist (Berl). 2003 Oct;44(10):1243-52. doi: 10.1007/s00108-003-1050-1. German.'}]}, 'descriptionModule': {'briefSummary': 'Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.', 'detailedDescription': 'Patients with chronic adrenal insufficiency (AI) are at risk of suffering from life-threatening adrenal crisis (AC), despite established hormone replacement therapies and patient education. Recent retrospective analyses observed different risk factors for AC, e.g. primary AI and comorbidities. Furthermore, patients that already experienced an AC seem to have an increased risk to develop further AC. The aim of the study is to evaluate potential risk factors/predisposing factors for AC in patients with chronic primary and secondary AI (PAI/SAI). Patients with chronic AI are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. AI patients with a high frequency of AC will be compared to matched controls (age, sex and cause of AI) with no AC or a low frequency of AC in the past.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic adrenal insufficiency under hormone replacement therapy with glucocorticoids.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Patient´s written informed consent\n* Ability to comply with the protocol procedures\n* Patients with chronic primary or secondary adrenal insufficiency under established stable replacement therapy (disease duration at least 2 years)\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy or breast feeding\n* Intake of CYP3A4-inducting-drugs'}, 'identificationModule': {'nctId': 'NCT03410160', 'acronym': 'PIA', 'briefTitle': 'Predisposing Factors for the Incidence of Adrenal Crisis', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Predisposing Factors for the Incidence of Adrenal Crisis in Chronic Adrenal Insufficiency', 'orgStudyIdInfo': {'id': 'PIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High frequency of adrenal crisis', 'description': 'Patients with a high frequency of adrenal crisis in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).', 'interventionNames': ['Diagnostic Test: Clinical and biochemical examination.']}, {'label': 'Low frequency of adrenal crisis', 'description': 'Patients with no adrenal crisis or a low frequency of AC in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).', 'interventionNames': ['Diagnostic Test: Clinical and biochemical examination.']}], 'interventions': [{'name': 'Clinical and biochemical examination.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.', 'armGroupLabels': ['High frequency of adrenal crisis', 'Low frequency of adrenal crisis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Wuerzburg, Dept. of medicine I', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Stefanie Hahner, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univesity Hospital Wuerzburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}