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Diabetes Mellitus, Type 2Phase 4ST2OMPNCT04128995

Surgical or Medical Treatment

A Phase 4 study testing Advanced Medical Therapy and Bariatric Surgery, Advanced Medical Therapy and Bariatric Surgery in people with Diabetes Mellitus, Type 2 and Pediatric Obesity, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 years
What is being tested?
Advanced Medical Therapy and Bariatric Surgery, Advanced Medical Therapy and Bariatric Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
3 sitesUnited States
Study dates
15 Dec 2019to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Lurie Children's Hospital

    Chicago, Illinois, 60611

  • Cincinnati Childrens

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Advanced Medical Therapy and Bariatric Surgery, Advanced Medical Therapy, Bariatric Surgery
Medical subject headings
Diabetes Mellitus, Type 2, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced Medical Therapy and Bariatric SurgeryProcedure or 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

  • Advanced Medical TherapyDrug

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

  • Bariatric SurgeryProcedure or surgery

    Also called Vertical Sleeve Gastrectomy

    Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Study groups in NCT04128995
Study groupRoleWhat they receive
Medical Therapy and Bariatric Surgery in Youth with Type 2 DiabetesActive comparatorYouth with type 2 diabetes undergoing bariatric surgery, n=45
Receives: Procedure: Advanced Medical Therapy and Bariatric Surgery
Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 DiabetesActive comparatorYouth with type 2 diabetes receiving medical management, n=45
Receives: Drug: Advanced Medical Therapy
Bariatric Surgery in Youth with ObesityActive comparatorYouth with no obesity undergoing bariatric surgery, n=10
Receives: Procedure: Bariatric Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic Control

    Hemoglobin A1c of <6.5%

    Measured: At one year

Secondary outcomes (9)

  1. Glycemic Control

    Hemoglobin A1c <6.5% at 2 years

    Measured: At two years

  2. Glycemic Variability

    Time In Range by Continuous Glucose Monitoring

    Measured: At one year

  3. Beta Cell Function

    Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]

    Measured: at 1 and 2 years

  4. Alpha cell function

    Glucagon area under the curve from mixed meal tolerance testing

    Measured: at 1 and 2 years

  5. Incretin Response

    GLP-1 area under the curve from mixed meal tolerance testing

    Measured: at 1 and 2 years

  6. Fatty Liver Disease

    Hepatic Fat (<5% )by Magnetic Resonance imaging

    Measured: at 1 and 2 years

  7. Dyslipidemia

    LDL <130mg/dL

    Measured: at 1 and 2 years

  8. Hypertension

    Blood pressure <130/80 mmHg

    Measured: at 1 and 2 years

  9. Diabetic Kidney Disease

    Urinary albumin excretion <30μg/mg

    Measured: At 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start15 Dec 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04128995
Sponsor's protocol ID
R01DK119450
Acronym
ST2OMP
Status last verified
Mar 2026
First submitted
11 Oct 2019
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 34389568

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Advanced Medical Therapy and Bariatric Surgery, Advanced Medical Therapy and Bariatric Surgery in people with Diabetes Mellitus, Type 2 and Pediatric Obesity, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Control (time frame: At one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04128995, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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