← Trials/Trial dossier/NCT04128995

ST2OMP

Active not recruitingPhase 4

Surgical or Medical Treatment

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Bariatric Surgery Candidate, Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c <6.5% achievement

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04128995

Org study IDR01DK119450

Timeline

Milestones

Study first posted2019-10-16actual

Study start2019-12-15actual

Last update posted2026-03-24actual

Primary completion2026-12estimated (month precision)

Study completion2026-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Bariatric Surgery CandidateObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age13 Years

Maximum age19 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

MASH / liver

Renal / kidney

Other (unclassified)

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Glycemic Control

Time frame:At one year

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycemic Control

Time frame:At two years

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glycemic Variability

Time frame:At one year

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint/low confidence

Beta Cell Function

Time frame:at 1 and 2 years

descriptive, improvement

Secondary/protocol endpoint/low confidence

Alpha cell function

Time frame:at 1 and 2 years

descriptive

MASH / liver

1 endpoint

Secondary/protocol endpoint

Fatty Liver Disease

Time frame:at 1 and 2 years

Liver fat content, change

threshold achievement, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Diabetic Kidney Disease

Time frame:At 1 and 2 years

Albuminuria regression

threshold achievement, improvement

LOINC 9318-7

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Dyslipidemia

Time frame:at 1 and 2 years

LDL-C, change

threshold achievement, improvement

LOINC 13457-7

Secondary/protocol endpoint

Hypertension

Time frame:at 1 and 2 years

threshold achievement, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Incretin Response

Time frame:at 1 and 2 years

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST(2)OMP).
BMJ open2021 Aug 13PMID34389568doi:10.1136/bmjopen-2020-047766via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.