NCT04128995

Surgical or Medical Treatment

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

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 type 2 diabetes.

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 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.

Conditions

• Diabetes Mellitus, Type 2
• Pediatric Obesity
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	Advanced Medical Therapy and Bariatric Surgery	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
DRUG	Advanced Medical Therapy	Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
PROCEDURE	Bariatric Surgery	Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Timeline

• Start date: 2019-12-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-10-16
• Last updated: 2026-03-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study