Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
Study NCT ID:
NCT01727661
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2012-07-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2012-07-08', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise testing with near-infrared spectroscopy', 'timeFrame': 'at baseline'}], 'secondaryOutcomes': [{'measure': 'lung function', 'timeFrame': 'at baseline', 'description': 'flow volume loop, lung diffusing capacity'}, {'measure': 'quality of life', 'timeFrame': 'at baseline', 'description': 'short-forum 36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'cardiopulmonary fitness', 'lung function', 'muscular oxygenation'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '1576807', 'type': 'BACKGROUND', 'citation': 'Wanke T, Formanek D, Auinger M, Zwick H, Irsigler K. Pulmonary gas exchange and oxygen uptake during exercise in patients with type 1 diabetes mellitus. Diabet Med. 1992 Apr;9(3):252-7. doi: 10.1111/j.1464-5491.1992.tb01771.x.'}, {'pmid': '20807874', 'type': 'BACKGROUND', 'citation': 'Komatsu WR, Barros Neto TL, Chacra AR, Dib SA. Aerobic exercise capacity and pulmonary function in athletes with and without type 1 diabetes. Diabetes Care. 2010 Dec;33(12):2555-7. doi: 10.2337/dc10-0769. Epub 2010 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the differences of\n\n1. cardiopulmonary fitness\n2. lung function\n3. muscular oxygen saturation\n4. quality of life between type 1 diabetes mellitus and healthy adults.', 'detailedDescription': 'This study is also to investigate the relationships between cardiopulmonary fitness, lung function, muscular oxygen saturation, glycemic control, and quality of life in patients with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group)\n* age-, gender-, and BMI-matched healthy subjects (control group)\n\nExclusion Criteria:\n\n* cardiac or respiratory disease\n* pregnancy\n* hospitalization due to any medical condition in recent 6 months\n* any other condition affecting exercise performance or lung function.'}, 'identificationModule': {'nctId': 'NCT01727661', 'briefTitle': 'Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '201201005RIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 1 diabetes mellitus', 'description': '1. exercise testing with near-infrared spectroscopy\n2. lung function testing\n3. quality of life', 'interventionNames': ['Behavioral: exercise testing with near-infrared spectroscopy', 'Behavioral: lung function testing', 'Behavioral: quality of life']}, {'label': 'healthy controls', 'description': '1. exercise testing with near-infrared spectroscopy\n2. lung function testing\n3. quality of life', 'interventionNames': ['Behavioral: exercise testing with near-infrared spectroscopy', 'Behavioral: lung function testing', 'Behavioral: quality of life']}], 'interventions': [{'name': 'exercise testing with near-infrared spectroscopy', 'type': 'BEHAVIORAL', 'description': 'subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.', 'armGroupLabels': ['healthy controls', 'type 1 diabetes mellitus']}, {'name': 'lung function testing', 'type': 'BEHAVIORAL', 'description': 'spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation.\n\nsingle-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.', 'armGroupLabels': ['healthy controls', 'type 1 diabetes mellitus']}, {'name': 'quality of life', 'type': 'BEHAVIORAL', 'description': 'assessing quality of life using short-forum 36 (questionnaire)', 'armGroupLabels': ['healthy controls', 'type 1 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ying-Tai Wu, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}