Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT04128995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2019-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical or Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label prospective clinical trial. Primary comparison is medical (n=45) vs surgical (n=45) groups. Patients with obesity and no diabetes (n=10) are a comparator group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control', 'timeFrame': 'At one year', 'description': 'Hemoglobin A1c of \\<6.5%'}], 'secondaryOutcomes': [{'measure': 'Glycemic Control', 'timeFrame': 'At two years', 'description': 'Hemoglobin A1c \\<6.5% at 2 years'}, {'measure': 'Glycemic Variability', 'timeFrame': 'At one year', 'description': 'Time In Range by Continuous Glucose Monitoring'}, {'measure': 'Beta Cell Function', 'timeFrame': 'at 1 and 2 years', 'description': 'Oral disposition index= Insulin secretion \\[insulinogenic index\\] \\* insulin sensitivity \\[1/fasting insulin\\]'}, {'measure': 'Alpha cell function', 'timeFrame': 'at 1 and 2 years', 'description': 'Glucagon area under the curve from mixed meal tolerance testing'}, {'measure': 'Incretin Response', 'timeFrame': 'at 1 and 2 years', 'description': 'GLP-1 area under the curve from mixed meal tolerance testing'}, {'measure': 'Fatty Liver Disease', 'timeFrame': 'at 1 and 2 years', 'description': 'Hepatic Fat (\\<5% )by Magnetic Resonance imaging'}, {'measure': 'Dyslipidemia', 'timeFrame': 'at 1 and 2 years', 'description': 'LDL \\<130mg/dL'}, {'measure': 'Hypertension', 'timeFrame': 'at 1 and 2 years', 'description': 'Blood pressure \\<130/80 mmHg'}, {'measure': 'Diabetic Kidney Disease', 'timeFrame': 'At 1 and 2 years', 'description': 'Urinary albumin excretion \\<30μg/mg'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Pediatric Obesity', 'Bariatric Surgery Candidate']}, 'referencesModule': {'references': [{'pmid': '34389568', 'type': 'DERIVED', 'citation': 'Shah AS, Helmrath MA, Inge TH, Xanthakos SA, Kelsey MM, Jenkins T, Trout AT, Browne L, Nadeau KJ. Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP). BMJ Open. 2021 Aug 13;11(8):e047766. doi: 10.1136/bmjopen-2020-047766.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.', 'detailedDescription': 'Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are in-adequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG).\n\nWe will test the hypothesis that VSG will be more effective in reducing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, 90 adolescents with T2D will be studied to compare the effects of VSG vs. AMT on glycemic control and T2D-associated comorbidities, as well as underlying mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for the medical or surgical type 2 diabetes groups\n\n* Age 13-19.9 years of age at time of signing the consent\n* Type 2 diabetes by the American Diabetes Association criteria\n* Negative diabetes-associated antibodies\n\nExclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes\n\n* Any chronic oral steroids use within 60 days of enrollment\n* Current pancreatotoxic drugs\n* Chronic kidney or liver disease (except NAFLD or DKD)\n* Pregnancy, breast-feeding or intension of becoming pregnant\n* Prior bariatric surgery\n* History of malignancy\n* Current participation in another clinical trial that may affect study outcomes\n* Other conditions, that in the determination of the study investigator, may interfere with study participation\n* Inclusion Criteria for the Obese control group\n* Age 13-19.9 years of age at time of signing the consent\n* Clinical indication to receive bariatric surgery\n\nExclusion Criteria for the obese control group\n\n* Known diabetes\n* Any chronic oral steroids use within 60 days of enrollment\n* Current pancreatotoxic drugs\n* Chronic kidney or liver disease (except NAFLD or DKD)\n* Pregnancy, breast-feeding or intension of becoming pregnant\n* Prior bariatric surgery\n* History of malignancy\n* Current participation in another clinical trial that may affect study outcomes\n* Other conditions, that in the determination of the study investigator, may interfere with study participation'}, 'identificationModule': {'nctId': 'NCT04128995', 'acronym': 'ST2OMP', 'briefTitle': 'Surgical or Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Surgical or Medical Treatment for Pediatric Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'R01DK119450', 'link': 'https://reporter.nih.gov/quickSearch/R01DK119450', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes', 'description': 'Youth with type 2 diabetes undergoing bariatric surgery, n=45', 'interventionNames': ['Procedure: Advanced Medical Therapy and Bariatric Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes', 'description': 'Youth with type 2 diabetes receiving medical management, n=45', 'interventionNames': ['Drug: Advanced Medical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bariatric Surgery in Youth with Obesity', 'description': 'Youth with no obesity undergoing bariatric surgery, n=10', 'interventionNames': ['Procedure: Bariatric Surgery']}], 'interventions': [{'name': 'Advanced Medical Therapy and Bariatric Surgery', 'type': 'PROCEDURE', 'description': 'Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes', 'armGroupLabels': ['Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes']}, {'name': 'Advanced Medical Therapy', 'type': 'DRUG', 'description': 'Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes', 'armGroupLabels': ['Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes']}, {'name': 'Bariatric Surgery', 'type': 'PROCEDURE', 'otherNames': ['Vertical Sleeve Gastrectomy'], 'description': 'Vertical Sleeve Gastrectomy for youth without type 2 diabetes', 'armGroupLabels': ['Bariatric Surgery in Youth with Obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Amy S Shah, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cincinnati Childrens Hospital Medical Center'}, {'name': 'Kristen J Nadeau, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}, {'name': 'Michael A Helmrath, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Thomas H Inge, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Lurie Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The PI's will also report a of summary results information (including adverse events) after completion of the study. All data from the study including any negative findings will be published in peer reviewed manuscripts."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Colorado", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Pediatrics', 'investigatorFullName': 'Amy Shah', 'investigatorAffiliation': "Children's Hospital Medical Center, Cincinnati"}}}}