Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01452893
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2011-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000224', 'term': 'Addison Disease'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples for hormonal analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in cognitive function before and after physical stress', 'timeFrame': 'testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min)', 'description': 'study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenuous activity at a bicycle ergometer.'}], 'secondaryOutcomes': [{'measure': 'differences in counterregulatory hormonal response to physical stress', 'timeFrame': 'at visit 2, blood sampling over 180 min starting 10 min before spiroergometry', 'description': 'blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Addison's Disease", 'Adrenal Insufficiency', 'Diabetes Mellitus Type I']}, 'descriptionModule': {'briefSummary': "Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.", 'detailedDescription': "As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Four groups:\n\nPatients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation\n* Age ≥ 18 years\n* Ability to comply with the study protocol\n* Capability to perform spiroergometry\n\nExclusion Criteria:\n\n* Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:\n\n * acute myocardial infarction\n * instable angina pectoris\n * symptomatic arrhythmia\n * severe and symptomatic stenosis of the aortic valve\n * decompensated heart failure\n * acute pulmonary embolism\n * Acute myocarditis\n * Acute pericarditis\n * Acute aortic dissection\n * main coronary artery disease\n * valvulopathies\n * electrolyte disturbance\n * arterial hypertension (systolic blood pressure \\> 200 mm Hg, diastolic BP \\> 110 mm Hg)\n * Tachyarrhythmia or Bradyarrhythmia\n * Hypertrophic cardiomyopathy and other forms of obstructive heart disease\n * second or third degree atrioventricular block\n* Fever\n* Diabetes mellitus Type 2\n* Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)\n* Glucocorticoid-pharmacotherapy"}, 'identificationModule': {'nctId': 'NCT01452893', 'acronym': 'CANDI', 'briefTitle': 'Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I', 'organization': {'class': 'OTHER', 'fullName': 'University of Wuerzburg'}, 'officialTitle': 'Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I', 'orgStudyIdInfo': {'id': 'CANDI-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type I diabetes', 'description': 'Adult patients with diabetes mellitus type I but normal adrenal function', 'interventionNames': ['Procedure: Spiroergometry']}, {'label': "Addison's disease", 'description': "Adult patients with Addison's disease", 'interventionNames': ['Procedure: Spiroergometry']}, {'label': "Type I diabetes and Addison's disease", 'description': "Patients suffering from both, diabetes mellitus type I and Addison's disease", 'interventionNames': ['Procedure: Spiroergometry']}, {'label': 'healthy controls', 'description': 'healthy controls with normal adrenal function and normal glucose regulation', 'interventionNames': ['Procedure: Spiroergometry']}], 'interventions': [{'name': 'Spiroergometry', 'type': 'PROCEDURE', 'description': 'At visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function.\n\nAt visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP).', 'armGroupLabels': ["Addison's disease", 'Type I diabetes', "Type I diabetes and Addison's disease", 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Bruno Allolio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Wuerzburg'}, {'name': 'Stefanie Hahner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wuerzburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of medicine, head of the department of endocrinology and diabetology', 'investigatorFullName': 'Bruno Allolio', 'investigatorAffiliation': 'University of Wuerzburg'}}}}