Surgical or Medical Treatment

Phase 4

Recruiting

• Conditions: Pediatric Obesity; Diabetes Mellitus, Type 2; Bariatric Surgery Candidate
• Interventions: Procedure: Advanced Medical Therapy and Bariatric Surgery; Drug: Advanced Medical Therapy; Procedure: Bariatric Surgery

• Registration Number: NCT04128995
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 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.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-12-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes	Advanced Medical Therapy and Bariatric Surgery	Youth with type 2 diabetes undergoing bariatric surgery, n=45
Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes	Advanced Medical Therapy	Youth with type 2 diabetes receiving medical management, n=45
Bariatric Surgery in Youth with Obesity	Bariatric Surgery	Youth with no obesity undergoing bariatric surgery, n=10

Primary Outcome Measures

Name	Time	Method
Glycemic Control	At one year	Hemoglobin A1c of \<6.5%

Secondary Outcome Measures

Name	Time	Method
Glycemic Variability	At one year	Time In Range by Continuous Glucose Monitoring
Alpha cell function	at 1 and 2 years	Glucagon area under the curve from mixed meal tolerance testing
Beta Cell Function	at 1 and 2 years	Oral disposition index= Insulin secretion \[insulinogenic index\] \* insulin sensitivity \[1/fasting insulin\]
Diabetic Kidney Disease	At 1 and 2 years	Urinary albumin excretion \<30μg/mg
Dyslipidemia	at 1 and 2 years	LDL \<130mg/dL
Hypertension	at 1 and 2 years	Blood pressure \<130/80 mmHg
Incretin Response	at 1 and 2 years	GLP-1 area under the curve from mixed meal tolerance testing
Fatty Liver Disease	at 1 and 2 years	Hepatic Fat (\<5% )by Magnetic Resonance imaging
Glycemic Control	At two years	Hemoglobin A1c \<6.5% at 2 years

Trial Locations

Locations (3)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Cincinnati Childrens; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States