Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT02959034
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2016-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Metabolism and Microbiome Repository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings.\n\nSpecimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measure of abnormal metabolism using a sample biorepository', 'timeFrame': '5 years', 'description': 'measures of metabolomics using a sample biorepository'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '39974080', 'type': 'DERIVED', 'citation': 'McCann JR, Yang C, Bihlmeyer NA, Tang R, Truong T, An J, Jawahar J, Ilkayeva O, Muehlbauer MJ, Hu Z, Dressman HK, Poppe L, Granek JA, David LA, Shi P, Balikcioglu PG, Shah SH, Armstrong SC, Newgard CB, Seed PC, Rawls JF. Branched chain amino acid metabolism and microbiome in adolescents with obesity during weight loss therapy. medRxiv [Preprint]. 2025 Jun 9:2025.02.03.25321363. doi: 10.1101/2025.02.03.25321363.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.', 'detailedDescription': 'Human microbial cell lines, stool and/or DNA and RNA will be collected from participants 10-18 years with a BMI greater than 95th percentile and their healthy siblings.\n\nSpecimens will be collected at 3 time points over a seven month period. Healthy siblings will provide just one blood and stool sample. Samples will be maintained at the Duke Medical Science Research Laboratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Samples will be collected upon consent from the patient poplation of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of the Healthy Lifestyles Program at Duke for the care of children with obesity, a sibling of a patient in the Healthy Lifestyles Program, or is a patient at Duke Children's Primary Care.\n\nExclusion Criteria:\n\n* Pregnant females."}, 'identificationModule': {'nctId': 'NCT02959034', 'acronym': 'PMMR', 'briefTitle': 'Pediatric Metabolism and Microbiome Repository', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pediatric Metabolism and Microbiome Repository', 'orgStudyIdInfo': {'id': 'Pro00074547'}, 'secondaryIdInfos': [{'id': '1R24DK110492-01', 'link': 'https://reporter.nih.gov/quickSearch/1R24DK110492-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'BMI > 95%', 'description': 'No Intervention'}, {'label': 'Healthy Weight Siblings', 'description': 'Control'}, {'label': 'Healthy Weight Unrelated', 'description': 'Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sarah C Armstrong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available by December 31 2021', 'ipdSharing': 'YES', 'description': 'Anonymized data may be shared at investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval', 'accessCriteria': 'Anonymized data may be shared as investigators discretion following submission of request, receipt of a data transfer agreement and local IRB approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}