Surgical or Medical Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Type 2 Pediatric Obesity Bariatric Surgery Candidate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open label prospective clinical trial. Primary comparison is medical (n=45) vs surgical (n=45) groups. Patients with obesity and no diabetes (n=10) are a comparator group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes

Youth with type 2 diabetes undergoing bariatric surgery, n=45

Group Type ACTIVE_COMPARATOR

Advanced Medical Therapy and Bariatric Surgery

Intervention Type PROCEDURE

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

Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes

Youth with type 2 diabetes receiving medical management, n=45

Group Type ACTIVE_COMPARATOR

Advanced Medical Therapy

Intervention Type DRUG

Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes

Bariatric Surgery in Youth with Obesity

Youth with no obesity undergoing bariatric surgery, n=10

Group Type ACTIVE_COMPARATOR

Bariatric Surgery

Intervention Type PROCEDURE

Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type DRUG

Bariatric Surgery

Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Intervention Type PROCEDURE

Other Intervention Names

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Vertical Sleeve Gastrectomy

Eligibility Criteria

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Inclusion Criteria

* Age 13-19.9 years of age at time of signing the consent
* Type 2 diabetes by the American Diabetes Association criteria
* Negative diabetes-associated antibodies

* Age 13-19.9 years of age at time of signing the consent
* Clinical indication to receive bariatric surgery

Exclusion Criteria

* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation

* Known diabetes
* Any chronic oral steroids use within 60 days of enrollment
* Current pancreatotoxic drugs
* Chronic kidney or liver disease (except NAFLD or DKD)
* Pregnancy, breast-feeding or intension of becoming pregnant
* Prior bariatric surgery
* History of malignancy
* Current participation in another clinical trial that may affect study outcomes
* Other conditions, that in the determination of the study investigator, may interfere with study participation

Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No