NCT04128995Active, not recruitingPhase 4
Surgical or Medical Treatment
Surgical or Medical Treatment for Pediatric Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 11 Oct 2019
- Start date
- 15 Dec 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04128995
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 88
- From 15 Dec 2019 to the primary completion date, 31 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any chronic oral steroids use within 60 days of enrollment
- Current pancreatotoxic drugs
- Prior bariatric surgery
- Clinical indication to receive bariatric surgery
- Any chronic oral steroids use within 60 days of enrollment
- Current pancreatotoxic drugs
- Prior bariatric surgery
Other illness
- Chronic kidney or liver disease (except NAFLD or DKD)
- History of malignancy
- Other conditions, that in the determination of the study investigator, may interfere with study participation
- Known diabetes
- Chronic kidney or liver disease (except NAFLD or DKD)
- History of malignancy
- Other conditions, that in the determination of the study investigator, may interfere with study participation
Age
- Age 13-19.9 years of age at time of signing the consent
Other
- Pregnancy, breast-feeding or intension of becoming pregnant
- Current participation in another clinical trial that may affect study outcomes
- Inclusion Criteria for the Obese control group
- Pregnancy, breast-feeding or intension of becoming pregnant
- Current participation in another clinical trial that may affect study outcomes
Who the study is looking for
- 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
Age in the registry: 13 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Childrens Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.