Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-02 @ 12:07 AM
Study NCT ID:
NCT03014856
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2016-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Phenotypes in Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma for proton-NMR spectroscopy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metabolic phenotype of childhood obesity', 'timeFrame': 'day 1', 'description': 'Significant metabolic changes in blood plasma of obese children and adolescents and normal-weight control subjects'}], 'secondaryOutcomes': [{'measure': 'metabolic phenotype of metabolically healthy and unhealthy obese children and adolescents', 'timeFrame': 'day 1', 'description': 'Significant metabolic changes in blood plasma of metabolically healthy obese and metabolically unhealthy obese children and adolescents'}]}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Metabolomics', 'NMR spectroscopy'], 'conditions': ['Obesity, Pediatric']}, 'referencesModule': {'references': [{'pmid': '18007604', 'type': 'BACKGROUND', 'citation': 'Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.'}, {'pmid': '24574347', 'type': 'BACKGROUND', 'citation': 'Prince RL, Kuk JL, Ambler KA, Dhaliwal J, Ball GD. Predictors of metabolically healthy obesity in children. Diabetes Care. 2014 May;37(5):1462-8. doi: 10.2337/dc13-1697. Epub 2014 Feb 26.'}, {'pmid': '26085512', 'type': 'BACKGROUND', 'citation': 'Butte NF, Liu Y, Zakeri IF, Mohney RP, Mehta N, Voruganti VS, Goring H, Cole SA, Comuzzie AG. Global metabolomic profiling targeting childhood obesity in the Hispanic population. Am J Clin Nutr. 2015 Aug;102(2):256-67. doi: 10.3945/ajcn.115.111872. Epub 2015 Jun 17.'}, {'pmid': '25251340', 'type': 'BACKGROUND', 'citation': 'Perng W, Gillman MW, Fleisch AF, Michalek RD, Watkins SM, Isganaitis E, Patti ME, Oken E. Metabolomic profiles and childhood obesity. Obesity (Silver Spring). 2014 Dec;22(12):2570-8. doi: 10.1002/oby.20901. Epub 2014 Sep 24.'}, {'pmid': '22266733', 'type': 'BACKGROUND', 'citation': 'Mihalik SJ, Michaliszyn SF, de las Heras J, Bacha F, Lee S, Chace DH, DeJesus VR, Vockley J, Arslanian SA. Metabolomic profiling of fatty acid and amino acid metabolism in youth with obesity and type 2 diabetes: evidence for enhanced mitochondrial oxidation. Diabetes Care. 2012 Mar;35(3):605-11. doi: 10.2337/DC11-1577. Epub 2012 Jan 20.'}, {'pmid': '23108202', 'type': 'BACKGROUND', 'citation': 'Wahl S, Yu Z, Kleber M, Singmann P, Holzapfel C, He Y, Mittelstrass K, Polonikov A, Prehn C, Romisch-Margl W, Adamski J, Suhre K, Grallert H, Illig T, Wang-Sattler R, Reinehr T. Childhood obesity is associated with changes in the serum metabolite profile. Obes Facts. 2012;5(5):660-70. doi: 10.1159/000343204. Epub 2012 Oct 4.'}, {'pmid': '30057787', 'type': 'DERIVED', 'citation': 'Bervoets L, Massa G, Guedens W, Reekmans G, Noben JP, Adriaensens P. Identification of metabolic phenotypes in childhood obesity by 1H NMR metabolomics of blood plasma. Future Sci OA. 2018 May 23;4(6):FSO310. doi: 10.4155/fsoa-2017-0146. eCollection 2018 Jul.'}]}, 'descriptionModule': {'briefSummary': 'This study provides a sound basis towards a better understanding of the biochemical mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great importance towards the development of more personalized prevention and treatment in future.', 'detailedDescription': 'The aim of this study was to identify the plasma metabolic profile associated with childhood obesity and its phenotypes..\n\nThis cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. These integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct a classification model in discriminating between OB and NW children and adolescents. In addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically "healthy" obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both classified as obese but with respectively, none (MHO) or at least two components (MUO) of the metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 8 to 18\n* normal-weight, overweight or obese according to the International Obesity Task Force (IOTF) Body Mass Index (BMI) criteria\n* fasted for at least 8 hours\n\nExclusion Criteria:\n\n* Subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,'}, 'identificationModule': {'nctId': 'NCT03014856', 'briefTitle': 'Metabolic Phenotypes in Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Identification of Metabolic Phenotypes in Childhood Obesity by 1H-NMR Metabolomics of Blood Plasma', 'orgStudyIdInfo': {'id': 'LCRP-OBNMR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OB-NMR', 'description': 'overweight and obese children and adolescents', 'interventionNames': ['Other: Blood sampling']}, {'label': 'NMR-C', 'description': 'normal-weight children and adolescents', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy', 'armGroupLabels': ['NMR-C', 'OB-NMR']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter Adriaensens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Material Research, Hasselt University'}, {'name': 'Liene Bervoets, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasselt University'}, {'name': 'Guy Massa, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jessa Ziekenhuis Hasselt'}, {'name': 'Wanda Guedens, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Material Research, Hasselt University'}, {'name': 'Gunter Reekmans, Ing', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Material Research, Hasselt University'}, {'name': 'Jean-Paul Noben, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'BIOMED, Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (hoogleraar)', 'investigatorFullName': 'Peter Adriaensens', 'investigatorAffiliation': 'Hasselt University'}}}}