Surgical or Medical Treatment

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.

Conditions

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

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

Sponsors & Collaborators

• Children's Hospital Colorado

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Amy S Shah, MD MS · Cincinnati Childrens Hospital Medical Center

• Kristen J Nadeau, MD MS · Children's Hospital Colorado

• Michael A Helmrath, MD MS · Children's Hospital Medical Center, Cincinnati

• Thomas H Inge, MD PhD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-15

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations