Surgical or Medical Treatment (ST2OMP)
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ClinicalTrials.gov Identifier: NCT04128995 |
Recruitment Status :
Recruiting
First Posted : October 16, 2019
Last Update Posted : April 6, 2023
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Pediatric Obesity Bariatric Surgery Candidate | Procedure: Advanced Medical Therapy and Bariatric Surgery Drug: Advanced Medical Therapy Procedure: Bariatric Surgery | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Surgical or Medical Treatment for Pediatric Type 2 Diabetes |
Actual Study Start Date : | December 15, 2019 |
Estimated Primary Completion Date : | September 1, 2024 |
Estimated Study Completion Date : | September 1, 2025 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes
Youth with type 2 diabetes undergoing bariatric surgery, n=45
|
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 |
Active Comparator: Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
Youth with type 2 diabetes receiving medical management, n=45
|
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 |
Active Comparator: Bariatric Surgery in Youth with Obesity
Youth with no obesity undergoing bariatric surgery, n=10
|
Procedure: Bariatric Surgery
Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Other Name: Vertical Sleeve Gastrectomy |
- Glycemic Control [ Time Frame: At one year ]Hemoglobin A1c of <6.5%
- Glycemic Control [ Time Frame: At two years ]Hemoglobin A1c <6.5% at 2 years
- Glycemic Variability [ Time Frame: At one year ]Time In Range by Continuous Glucose Monitoring
- Beta Cell Function [ Time Frame: at 1 and 2 years ]Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]
- Alpha cell function [ Time Frame: at 1 and 2 years ]Glucagon area under the curve from mixed meal tolerance testing
- Incretin Response [ Time Frame: at 1 and 2 years ]GLP-1 area under the curve from mixed meal tolerance testing
- Fatty Liver Disease [ Time Frame: at 1 and 2 years ]Hepatic Fat (<5% )by Magnetic Resonance imaging
- Dyslipidemia [ Time Frame: at 1 and 2 years ]LDL <130mg/dL
- Hypertension [ Time Frame: at 1 and 2 years ]Blood pressure <130/80 mmHg
- Diabetic Kidney Disease [ Time Frame: At 1 and 2 years ]Urinary albumin excretion <30μg/mg

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Ages Eligible for Study: | 13 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for the medical or surgical type 2 diabetes groups
- 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
Exclusion Criteria for the medical or surgical type 2 diabetes groups Known type 1 diabetes, maturity onset diabetes of the young (MODY), or secondary 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
- Inclusion Criteria for the Obese control group
- Age 13-19.9 years of age at time of signing the consent
- Clinical indication to receive bariatric surgery
Exclusion Criteria for the obese control group
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128995
Contact: Amy S Shah, MD | 513-636-4744 | amy.shah@cchmc.org | |
Contact: Kristen J Nadeau, MD | (720) 777-6128 | Kristen.Nadeau@childrenscolorado.org |
United States, Colorado | |
Children's Hospital Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Amy Baumgartner 720-777-6143 amy.baumgartner@childrenscolorado.org | |
Principal Investigator: Kristen J Nadeau, MD | |
Sub-Investigator: Megan M Kelsey, MD | |
Sub-Investigator: Sarkis Derderian, MD | |
United States, Illinois | |
Lurie Children's Hospital | Active, not recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Ohio | |
Cincinnati Childrens | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Allen Riegler 513-636-4744 jenni.sizemore@cchmc.org | |
Principal Investigator: Michael A Helmrath, MD | |
Principal Investigator: Amy S Shah, MD | |
Sub-Investigator: Stavra Xanthakos, MD |
Principal Investigator: | Amy S Shah, MD MS | Cincinnati Childrens Hospital Medical Center | |
Principal Investigator: | Kristen J Nadeau, MD MS | Children's Hospital Colorado | |
Principal Investigator: | Michael A Helmrath, MD MS | Children's Hospital Medical Center, Cincinnati | |
Principal Investigator: | Thomas H Inge, MD PhD | Lurie Children's Hospital |
Responsible Party: | Amy Shah, Professor, Department of Pediatrics, Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT04128995 |
Other Study ID Numbers: |
R01DK119450 ( U.S. NIH Grant/Contract ) |
First Posted: | October 16, 2019 Key Record Dates |
Last Update Posted: | April 6, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The PI's will also report a of summary results information (including adverse events) after completion of the study. All data from the study including any negative findings will be published in peer reviewed manuscripts. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Diabetes Mellitus, Type 2 Pediatric Obesity Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |