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Surgical or Medical Treatment (ST2OMP) Phase 4 88

Active, not recruiting
Clinical Trial NCT04128995 (ST2OMP) is designed to study Treatment for Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate. It is a Phase 4 interventional study that is active, not recruiting, having started on December 15, 2019, with plans to enroll 88 participants. Led by Children's Hospital Medical Center, Cincinnati, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 24, 2026.
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...Show More
Official Title

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Conditions
Diabetes Mellitus, Type 2Pediatric ObesityBariatric Surgery Candidate
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT04128995
Start Date (Actual)
2019-12-15
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
88
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorMedical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes
Youth with type 2 diabetes undergoing bariatric surgery, n=45
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 ComparatorMedical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
Youth with type 2 diabetes receiving medical management, n=45
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 ComparatorBariatric Surgery in Youth with Obesity
Youth with no obesity undergoing bariatric surgery, n=10
Bariatric Surgery
Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycemic Control
Hemoglobin A1c of \<6.5%
At one year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
13 Years
Eligible Sexes
All
  • 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

  • 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
Children's Hospital Medical Center, Cincinnati logoChildren's Hospital Medical Center, Cincinnati
Children's Hospital Colorado logoChildren's Hospital Colorado
Study Responsible Party
Amy Shah, Principal Investigator, Professor, Department of Pediatrics, Children's Hospital Medical Center, Cincinnati
No contact data.
3 Study Locations in 1 Countries

Colorado

Children's Hospital Colorado, Aurora, Colorado, 80045, United States

Illinois

Lurie Children's Hospital, Chicago, Illinois, 60611, United States

Ohio

Cincinnati Childrens, Cincinnati, Ohio, 45229, United States