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HomeTrials › NCT04128995

Obesity & weight · Phase 4 · Active, not recruiting

Surgical or Medical Treatment

NCT04128995 · Sponsor: Children's Hospital Medical Center, Cincinnati

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Advanced Medical Therapy for diabetes mellitus, type 2, pediatric obesity, bariatric surgery candidate.

Who can joinAll sexes, 13 Years – 19 Years
Healthy volunteersNo — diagnosis required
What you'd takeAdvanced Medical Therapy
Study length~7 years overall
Planned participants88
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Colorado

  • Children's Hospital Colorado — Aurora

Illinois

  • Lurie Children's Hospital — Chicago

Ohio

  • Cincinnati Childrens — Cincinnati

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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