Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT03035903
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Cost for Holding a MedGem® Indirect Calorimeter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-01', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Metabolic Rate (RMR)', 'timeFrame': '3 hours', 'description': 'Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resting Metabolic Rate']}, 'descriptionModule': {'briefSummary': "The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.", 'detailedDescription': 'Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:\n\n1. RMR with MedGem® Indirect Calorimeter\n2. RMR without MedGem® Indirect Calorimeter\n\nStudy recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-65 y\n* BMI 25-40 kg/m2\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Current smoker\n* Presently on a weight loss regimen\n* Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs\n* Claustrophobia\n* Pregnant or breastfeeding\n* Congestive heart failure\n* Chronic kidney disease\n* Pacemaker or other metal implants'}, 'identificationModule': {'nctId': 'NCT03035903', 'acronym': 'MEDGEM', 'briefTitle': 'Energy Cost for Holding a MedGem® Indirect Calorimeter', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Energy Cost for Holding a MedGem® Indirect Calorimeter', 'orgStudyIdInfo': {'id': 'PBRC 2016-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Not holding, then holding the MedGem®', 'description': 'Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.', 'interventionNames': ['Device: Not holding, then holding the MedGem®', 'Device: Holding, then not holding the MedGem®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Holding, then not holding the MedGem®', 'description': 'Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.', 'interventionNames': ['Device: Not holding, then holding the MedGem®', 'Device: Holding, then not holding the MedGem®']}], 'interventions': [{'name': 'Not holding, then holding the MedGem®', 'type': 'DEVICE', 'description': 'Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®', 'armGroupLabels': ['Holding, then not holding the MedGem®', 'Not holding, then holding the MedGem®']}, {'name': 'Holding, then not holding the MedGem®', 'type': 'DEVICE', 'description': 'Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®', 'armGroupLabels': ['Holding, then not holding the MedGem®', 'Not holding, then holding the MedGem®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Eric Ravussin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'WW International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Executive Director for Clinical Science', 'investigatorFullName': 'Eric Ravussin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}