Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-19 @ 12:39 AM
Study NCT ID:
NCT03550820
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2018-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004614', 'term': 'Emaciation'}], 'ancestors': [{'id': 'D013851', 'term': 'Thinness'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples (serum, plasma)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-26', 'studyFirstSubmitDate': '2018-05-26', 'studyFirstSubmitQcDate': '2018-05-26', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between energy balance and pulmonary MAC severity', 'timeFrame': 'Three years'}], 'secondaryOutcomes': [{'measure': 'Relation between inflammation (CRP et.) and pulmonary MAC severity', 'timeFrame': 'Three years'}, {'measure': 'Relation between bone mineral density and pulmonary MAC severity', 'timeFrame': 'Three years'}, {'measure': 'Relation between hormone secretion and pulmonary MAC severity', 'timeFrame': 'Three years'}, {'measure': 'Relation between pulmonary function and pulmonary MAC severity', 'timeFrame': 'Three years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary MAC', 'energy metabolism'], 'conditions': ['Pulmonary MAC', 'Energy Metabolism', 'Emaciation']}, 'descriptionModule': {'briefSummary': 'We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.', 'detailedDescription': 'Patients with pulmonary MAC with a lower BMI than healthy individuals also have a significantly poorer prognosis than those of normal weight. Emaciation in such patients is thought to be caused by destruction of lung structure from disease progression and an increased resting metabolic rate caused by the increased load from breathing; however, causes of emaciation and details of energy metabolism in these patients have not been studied.\n\nElucidating details of energy metabolism and causes of emaciation in patients with pulmonary MAC could provide the basis for improvement in nutritional status and activities of daily living through early nutrition therapy and rehabilitation. We propose to clarify the following:\n\nEnergy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie intake and consumption, and hormonal secretions.\n\nRelation between energy metabolism and degree of pulmonary MAC progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Petients with pulmonary MAC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with pulmonary MAC.\n\nExclusion Criteria:\n\n* Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.'}, 'identificationModule': {'nctId': 'NCT03550820', 'briefTitle': 'Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex', 'organization': {'class': 'OTHER', 'fullName': 'National Hospital Organization Minami Kyoto Hospital'}, 'officialTitle': 'Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex', 'orgStudyIdInfo': {'id': '28-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '610-0113', 'city': 'Jōyō', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'National Hospital Organization Minami Kyoto Hospital', 'geoPoint': {'lat': 34.84396, 'lon': 135.80561}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hospital Organization Minami Kyoto Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}