Surgical or Medical Treatment
ST2OMP
1 other identifier
interventional
88
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Dec 2019
Longer than P75 for phase_4 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedStudy Start
First participant enrolled
December 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 24, 2026
March 1, 2026
7 years
October 11, 2019
March 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic Control
Hemoglobin A1c of \<6.5%
At one year
Secondary Outcomes (9)
Glycemic Control
At two years
Glycemic Variability
At one year
Beta Cell Function
at 1 and 2 years
Alpha cell function
at 1 and 2 years
Incretin Response
at 1 and 2 years
- +4 more secondary outcomes
Study Arms (3)
Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes
ACTIVE COMPARATORYouth with type 2 diabetes undergoing bariatric surgery, n=45
Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes
ACTIVE COMPARATORYouth with type 2 diabetes receiving medical management, n=45
Bariatric Surgery in Youth with Obesity
ACTIVE COMPARATORYouth with no obesity undergoing bariatric surgery, n=10
Interventions
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
Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes
Vertical Sleeve Gastrectomy for youth without type 2 diabetes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Age 13-19.9 years of age at time of signing the consent
- Clinical indication to receive bariatric surgery
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Cincinnati Childrens
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 34389568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Pediatrics
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 16, 2019
Study Start
December 15, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.