Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-23 @ 12:54 PM
Study NCT ID:
NCT01998750
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'Saliva or blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of known or novel genetic variants in genes that underlie obesity.', 'timeFrame': '1.5-2 years', 'description': 'Identification of known or novel genetic variants in genes that underlie obesity.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of melanocortin receptor 4 mutations.', 'timeFrame': '2 years', 'description': 'We will test the hypothesis that 1-3% of early onset obesity could be explained by carriage of mutation of monogenic obesity such as melanocortin receptor 4 in a mixed pediatric population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'genetics', 'early-onset', 'childhood'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30811542', 'type': 'RESULT', 'citation': 'De Rosa MC, Chesi A, McCormack S, Zhou J, Weaver B, McDonald M, Christensen S, Liimatta K, Rosenbaum M, Hakonarson H, Doege CA, Grant SFA, Hirschhorn JN, Thaker VV. Characterization of Rare Variants in MC4R in African American and Latino Children With Severe Early-Onset Obesity. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2961-2970. doi: 10.1210/jc.2018-02657.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate genetic causes of early childhood obesity.\n\nThe investigators will enroll children and adults with severe early onset obesity (BMI \\> 99th percentile) diagnosed prior to 6 years of age. The investigators will ask questions about the health and eating behavior of the participants, and perform a brief physical examination. The investigators will collect saliva or blood to perform genetic testing from the participants and invite family members to enroll in the study.', 'detailedDescription': 'This is a clinical and genomic study designed to investigate monogenic causes of severe early childhood obesity.\n\nParticipants with severe early onset obesity will be identified by screening of the clinical database or referred for the study. These subjects will be invited to participate in the study. After obtaining informed consent, the investigators will obtain history on the proband and the family, and perform a brief examination in addition to collecting genetic material.\n\nTargeted sequencing of genes associated with monogenic and syndromic forms of obesity will be performed using next-generation sequencing. In selected individuals with favorable family history, exome or whole genome sequencing will be performed. Functional analysis of newly identified variants will be performed where possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll children with BMI \\> 99th percentile for age noted prior to 6 years of age. Current age of the child can vary from 0-21 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- BMI \\> 99th percentile documented at age \\< 6 years of age\n\nExclusion Criteria:\n\n* Known genetic causes of obesity\n* Known Endocrine causes of obesity.\n* Neurologic tumor, trauma or surgery\n* Prior malignancy or transplant\n* Known autoimmune diseases\n* Edema of a known or unknown cause\n* Prolonged steroid use.'}, 'identificationModule': {'nctId': 'NCT01998750', 'acronym': 'GECO', 'briefTitle': 'Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity.', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Study to Identify Rare Genetic Variants Causing Severe Early Childhood Obesity', 'orgStudyIdInfo': {'id': 'AAAR0351'}, 'secondaryIdInfos': [{'id': 'P00009351', 'type': 'OTHER', 'domain': "Boston Children's Hospital"}, {'id': '5K23DK110539-03', 'link': 'https://reporter.nih.gov/quickSearch/5K23DK110539-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early-onset severe obesity', 'description': 'The study will enroll individuals with early onset severe obesity (BMI \\> 99th percentile noted at an age \\< 6 years of age). Individuals with a known history of early onset obesity are eligible, regardless of their current age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vidhu Thaker, MD', 'role': 'CONTACT', 'email': 'vvt2114@cumc.columbia.edu', 'phone': '212-851-5315'}], 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Vidhu Thaker, M.D.', 'role': 'CONTACT', 'email': 'vvt2114@cumc.columbia.edu', 'phone': '212-851-5315'}], 'overallOfficials': [{'name': 'Vidhu Thaker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified data will be deposited in public databases at the end of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Vidhu V. Thaker', 'investigatorAffiliation': 'Columbia University'}}}}