Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 2:02 PM
Study NCT ID:
NCT00483769
Status:
COMPLETED
Last Update Posted:
2007-06-07
First Post:
2007-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Year Glargine Treatment in CFRD Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-06', 'studyFirstSubmitDate': '2007-06-06', 'studyFirstSubmitQcDate': '2007-06-06', 'lastUpdatePostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of decline in pulmonary function measured as FEV1', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Improvement of: Body Mass Index, Number of Lung Infections, HbA1c', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystis Fibrosis', 'Glucose intolerance', 'Glargine', 'FEV1%'], 'conditions': ['Cystic Fibrosis', 'Glucose Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '16123520', 'type': 'RESULT', 'citation': 'Franzese A, Spagnuolo MI, Sepe A, Valerio G, Mozzillo E, Raia V. Can glargine reduce the number of lung infections in patients with cystic fibrosis-related diabetes? Diabetes Care. 2005 Sep;28(9):2333. doi: 10.2337/diacare.28.9.2333. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.fibrosicistica.it', 'label': 'Cystic Fibrosis center of Naples is a service of tertiary cure for patients with Cystic Fibrosis regularly attending regional Cystic Fibrosis Center'}]}, 'descriptionModule': {'briefSummary': 'Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements', 'detailedDescription': 'To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a "gluco-score" ranging 0-5. Patients with gluco-score \\> 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by Cystic Fibrosis who had shown glucose derangements.\n\nExclusion Criteria:\n\n* Patients with/without Cystic Fibrosis without glucose derangements.'}, 'identificationModule': {'nctId': 'NCT00483769', 'briefTitle': 'One Year Glargine Treatment in CFRD Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements', 'orgStudyIdInfo': {'id': '234-234-234-234-234'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Glargine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Naples', 'country': 'Italy', 'facility': 'Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Adriana Franzese, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federico II University'}, {'name': 'Adriana Franzese, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center'}, {'name': 'Adriana Franzese, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}}}}