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ACTIVE NOT RECRUITING
NCT04128995
PHASE4

Surgical or Medical Treatment

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

Official title: Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Key Details

Gender

All

Age Range

13 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2019-12-15

Completion Date

2026-12

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

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

Locations (3)

Children's Hospital Colorado

Aurora, Colorado, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Cincinnati Childrens

Cincinnati, Ohio, United States