Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT01598233
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone mineral density and body composition', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density and body composition by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Change in fasting and postprandial glucose', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Change in Pulmonary function tests', 'timeFrame': 'Baseline and 6 months', 'description': 'Pulmonary function tests consiste of spirometry, body plethysmograph, diffusing capacity for carbon monoxide (DLco), and respiratory muscle strength. Measurements are conducted using the Collins Plus Pulmonary Function Testing Systems (Warren E. Collins, Inc., Braintree, MA, USA).'}, {'measure': 'Change in bone microarchitecture', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone microarchitecture by high-resolution peripheral quantitative computed tomography'}, {'measure': 'Change in lipid profile', 'timeFrame': 'Baseline and 6 months', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '29065923', 'type': 'DERIVED', 'citation': 'Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, de Mendonca LMC, de Godoy-Matos AF, Lopes AJ, Farias MLF. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017 Oct 24;15(1):211. doi: 10.1186/s12955-017-0790-x.'}, {'pmid': '28031749', 'type': 'DERIVED', 'citation': 'Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca LM, Godoy-Matos AF, Lopes AJ, Farias ML. Impact of a 6-month treatment with intragastric balloon on body composition and psychopathological profile in obese individuals with metabolic syndrome. Diabetol Metab Syndr. 2016 Dec 19;8:81. doi: 10.1186/s13098-016-0197-6. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metabolic syndrome (IDF criteria)\n\nExclusion Criteria:\n\n* menopause\n* older than 50 years\n* diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01598233', 'briefTitle': 'Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters', 'orgStudyIdInfo': {'id': '3056-CEP/HUPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intragastric balloon', 'description': 'Patients submitted to six-month intragastric balloon', 'interventionNames': ['Device: Silimed Intragastric balloon']}], 'interventions': [{'name': 'Silimed Intragastric balloon', 'type': 'DEVICE', 'description': 'Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution', 'armGroupLabels': ['Intragastric balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20.551-030', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Universidade Estadual do Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Miguel Madeira', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}