Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-17 @ 7:06 PM
Study NCT ID:
NCT02395003
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2015-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'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_WITHOUT_DNA', 'description': 'Basal plasma samples for measurements of glucose and glycerol enrichment, and glucose, insulin FFAs, leptin, C-peptide, glucagon, adiponectin, cortisol, growth hormone, catecholamines and amino acids, will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat Biopsies', 'timeFrame': 'Baseline', 'description': '1\\) To test whether the reduced transcription of key lipogenic/adipogenic genes in abd SAT in obese adolescents with a High VAT/SAT ratio translates functionally into a reduced in vivo TG synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and IR.'}], 'secondaryOutcomes': [{'measure': 'MRI', 'timeFrame': 'Baseline', 'description': 'Visceral to Subcutaneous fat storage ratio'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Pediatric'], 'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': 'Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents.', 'detailedDescription': 'The purpose of this study is to test whether the reduced transcription of key lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and insulin resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat intake (palmitate intake) alters ceramide concentration in both plasma and adipose tissue (AT) and the Inflammasome complex in the different fat distribution phenotypes and their associations with IR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight (85-95th% age and gender specific) or Obese (\\>95th% age and gender specific)\n* Ages 12-18 years\n* Absence of any endocrinopathy\n* Absence of any therapy with medication known to alter glucose metabolism (i.e.: Oral steroids, certain psychiatric medications such as Xeleca, Lithium, Paxil)\n* English Speaking subjects\n\nExclusion Criteria:\n\n* Any disease known to alter glucose metabolism (T2DM)\n* Diuretic Medication\n* Pregnant or breastfeeding\n* Type 1 or 2 diabetes'}, 'identificationModule': {'nctId': 'NCT02395003', 'briefTitle': 'Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents', 'orgStudyIdInfo': {'id': '1503015459'}, 'secondaryIdInfos': [{'id': '2R01HD028016-20A1', 'link': 'https://reporter.nih.gov/quickSearch/2R01HD028016-20A1', 'type': 'NIH'}, {'id': '2R01HD028016', 'link': 'https://reporter.nih.gov/quickSearch/2R01HD028016', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'High VAT/SAT high Palmitate Diet', 'description': 'Subjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks', 'interventionNames': ['Other: Palmitate Diet']}, {'label': 'Low VAT/SAT', 'description': 'Subjects with a low ratio of visceral to subcutaneous fat', 'interventionNames': ['Other: Palmitate Diet']}, {'label': 'Lean Controls', 'description': 'Lean control'}, {'label': 'High VAT/SAT- low Palmitate Diet', 'description': 'Subjects with a high ratio of visceral to subcutaneous fat consuming low Palmatite oil diet for 12 weeks'}], 'interventions': [{'name': 'Palmitate Diet', 'type': 'OTHER', 'description': 'Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.', 'armGroupLabels': ['High VAT/SAT high Palmitate Diet', 'Low VAT/SAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Sonia Caprio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}