Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 11:03 PM
Study NCT ID:
NCT02414867
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-10', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine total energy expenditure in 2 year old children', 'timeFrame': '15 days', 'description': 'Doubly labeled water is administered to 2 year old children and urine is collected at different time points.'}, {'measure': 'To determine fat oxidation in 2 year old children', 'timeFrame': '2-6 hours', 'description': 'Deuterated palmitate is administered and urine is collected at different time points.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '120 toddlers born from mothers of the Glowing study (NCT01131117)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.5-2.5 years of age\n* Mother is a participant of the Glowing study (NCT01131117)\n* Healthy without taking medication that can affect study outcomes, as determined by the PI\n\nExclusion Criteria:\n\n* None listed'}, 'identificationModule': {'nctId': 'NCT02414867', 'briefTitle': 'Total Energy Expenditure and Fat Oxidation in 2 Year Old Children', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Total Energy Expenditure and Fat Oxidation in 2 Year Old Children', 'orgStudyIdInfo': {'id': '203770'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Normal weight mothers'}, {'label': '2', 'description': 'Overweight/Obese mothers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Elisabet Borsheim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Nutrition Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}