Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-06-21 @ 4:46 PM
Study NCT ID:
NCT02635958
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
InBody Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition Measures', 'timeFrame': '1 day', 'description': 'compare body composition measures between InBody and iDXA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body Mass Index', 'BMI', 'InBody', 'iDXA', 'validation'], 'conditions': ['Validation Study']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.", 'detailedDescription': 'This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 65 years of age\n* Have a Body Mass Index ≥ 18.5 kg/m2\n\nExclusion Criteria:\n\n* Are not English speaking\n* Are younger than 18 years of age\n* Weigh more than 450 lbs\n* Taller than 6\'6" due to size constraints of the iDXA\n* Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator\n* People having radioactive iodine thyroid treatment.\n* People who have had a nuclear medicine study or a barium X-ray within the last 5 days.\n* People with large amounts of metal in their bodies.\n* People with arthritis of the spine recorded in the medical record.\n* Are pregnant'}, 'identificationModule': {'nctId': 'NCT02635958', 'acronym': 'InBody', 'briefTitle': 'InBody Validation Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Validation of the InBody 770® for the Assessment of Body Composition', 'orgStudyIdInfo': {'id': '14-004659'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'BMI 18.5 to 24.9'}, {'label': 'Group 2', 'description': 'BMI 25 to 29.9'}, {'label': 'Group 3', 'description': 'BMI 30 to 34.9'}, {'label': 'Group 4', 'description': 'BMI ≥ 35'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ryan T Hurt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioSpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Ryan T. Hurt, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}