Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01798420
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2013-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Hemoglobin A1C LEVEL', 'timeFrame': '3 MONTHS'}], 'secondaryOutcomes': [{'measure': 'Glucose levels', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Diabetes', 'steroids', 'Hemoglobin A1C DIFFERENCE'], 'conditions': ['Diabetes', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels', 'detailedDescription': "HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients with COPD ecaxerbation who are admitted to the hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients with COPD exacerbation\n\nExclusion Criteria:\n\n* Patients treated with steroids during the previous 3 months'}, 'identificationModule': {'nctId': 'NCT01798420', 'briefTitle': 'Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'The Nazareth Hospital, Israel'}, 'officialTitle': 'The Impact of Corticosteroid Treatment on Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation', 'orgStudyIdInfo': {'id': 'Hb-A1C-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Corticosteroid'}, {'label': 'non-corticosteroid group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Nzareth', 'state': 'Nazareth', 'country': 'Israel', 'facility': 'Department of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Nazareth Hospital, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Rheumatology clinic, Nzareth hospital, Nzareth', 'investigatorFullName': 'George Habib', 'investigatorAffiliation': 'The Nazareth Hospital, Israel'}}}}