Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2026-03-14 @ 4:24 AM
Study NCT ID:
NCT00863993
Status:
WITHDRAWN
Last Update Posted:
2015-02-12
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Expenditure and Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patients enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TDEE (total daily energy expenditure)', 'timeFrame': 'March 2009 to October 2013', 'description': 'Activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Bypass Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether activity thermogenesis increases in patients undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators will assess non-exercise activity thermogenesis using a validated Physical Activity Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18 months post-operatively. PAMS has been validated in lean and obese individuals. This is to assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest weight loss and once weight loss has plateaued. This will permit us to address our primary hypothesis that activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '40 healthy patients (M=F, aged 18-60 years) undergoing gastric bypass bariatric surgery will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing gastric bypass surgery, 18-60 years\n\nExclusion Criteria:\n\n* Eligible subjects will be excluded who cannot walk at 2.4 mph for 15 minutes, or weigh greater than 227 kg at the screening visit.'}, 'identificationModule': {'nctId': 'NCT00863993', 'briefTitle': 'Energy Expenditure and Gastric Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Energy Expenditure and Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': '05-004359'}, 'secondaryIdInfos': [{'id': 'R01DK072479', 'link': 'https://reporter.nih.gov/quickSearch/R01DK072479', 'type': 'NIH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'James Levine', 'investigatorAffiliation': 'Mayo Clinic'}}}}