Surgical or Medical Treatment (ST2OMP)

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Pediatric Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Advanced Medical Therapy and Bariatric Surgery; Drug: Advanced Medical Therapy; Procedure: Bariatric Surgery

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy S Shah, MD; Phone Number: 513-636-4744; Email: amy.shah@cchmc.org
• Study Contact Backup: Name: Kristen J Nadeau, MD; Phone Number: (720) 777-6128; Email: Kristen.Nadeau@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Amy Baumgartner; Phone Number: 720-777-6143; Email: amy.baumgartner@childrenscolorado.org
      • Principal Investigator: Kristen J Nadeau, MD
      • Sub-Investigator: Megan M Kelsey, MD
      • Sub-Investigator: Sarkis Derderian, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Active, not recruiting
      • Lurie Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Childrens
      • Contact: Allen Riegler; Phone Number: 513-636-4744; Email: jenni.sizemore@cchmc.org
      • Principal Investigator: Michael A Helmrath, MD
      • Principal Investigator: Amy S Shah, MD
      • Sub-Investigator: Stavra Xanthakos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Vertical Sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	Hemoglobin A1c of <6.5%	At one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Children's Hospital Colorado
• Investigators: 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

Publications and helpful links

General Publications

• Shah AS, Helmrath MA, Inge TH, Xanthakos SA, Kelsey MM, Jenkins T, Trout AT, Browne L, Nadeau KJ. Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP). BMJ Open. 2021 Aug 13;11(8):e047766. doi: 10.1136/bmjopen-2020-047766.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Diabetes Mellitus, Type 2; Pediatric Obesity
• Other Study ID Numbers: R01DK119450 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• 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