Surgical or Medical Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bariatric Surgery Candidate
- Diabetes Mellitus - Type 2
- Pediatric Obesity
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open label prospective clinical trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 13 years and 19 years
- Gender
- Both males and females
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 diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and curren...
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). We 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.
Tracking Information
- NCT #
- NCT04128995
- Collaborators
- Children's Hospital Colorado
- Investigators
- Principal Investigator: Amy S Shah, MD MS Cincinnati Childrens Hospital Medical Center Principal Investigator: Kristen J Nadeau, MD MS Children's Hospital Colorado Principal Investigator: Michael A Helmrath, MD MS Children's Hospital Medical Center, Cincinnati Principal Investigator: Thomas H Inge, MD PhD Children's Hospital Colorado
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