Status:
ACTIVE_NOT_RECRUITING
Surgical or Medical Treatment
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Children's Hospital Colorado
Conditions:
Diabetes Mellitus, Type 2
Pediatric Obesity
Eligibility:
All Genders
13-19 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 diab...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the medical or surgical type 2 diabetes groups
- Age 13-19.9 years of age at time of signing the consent
- Type 2 diabetes by the American Diabetes Association criteria
- Negative diabetes-associated antibodies
- Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary diabetes
- Any chronic oral steroids use within 60 days of enrollment
- Current pancreatotoxic drugs
- Chronic kidney or liver disease (except NAFLD or DKD)
- Pregnancy, breast-feeding or intension of becoming pregnant
- Prior bariatric surgery
- History of malignancy
- Current participation in another clinical trial that may affect study outcomes
- Other conditions, that in the determination of the study investigator, may interfere with study participation
- Inclusion Criteria for the Obese control group
- Age 13-19.9 years of age at time of signing the consent
- Clinical indication to receive bariatric surgery
- Exclusion Criteria for the obese control group
- Known diabetes
- Any chronic oral steroids use within 60 days of enrollment
- Current pancreatotoxic drugs
- Chronic kidney or liver disease (except NAFLD or DKD)
- Pregnancy, breast-feeding or intension of becoming pregnant
- Prior bariatric surgery
- History of malignancy
- Current participation in another clinical trial that may affect study outcomes
- Other conditions, that in the determination of the study investigator, may interfere with study participation
Exclusion
Key Trial Info
Start Date :
December 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04128995
Start Date
December 15 2019
End Date
December 1 2026
Last Update
October 22 2025
Active Locations (3)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
3
Cincinnati Childrens
Cincinnati, Ohio, United States, 45229