Surgery or pills? new study tests best way to treat teen diabetes
NCT ID NCT04128995
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two approaches for treating type 2 diabetes in teenagers: weight-loss surgery (vertical sleeve gastrectomy) versus intensive medical therapy (including metformin and other drugs). The goal is to see which method provides better blood sugar control and reduces related health problems. About 88 teens aged 13-19 with type 2 diabetes are participating.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bariatric surgery (vertical sleeve gastrectomy) and advanced medical therapy (metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin)
- What this could lead to
- If successful, this could show that bariatric surgery is a more effective option than medication alone for managing type 2 diabetes in teenagers, potentially leading to better long-term health.
- What could go wrong
- This is a relatively small study (88 participants) and results may not apply to all teens. Surgery carries risks, and the medical therapy may be just as effective for some. Long-term outcomes are still unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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88 people
The number who actually took part.
- Started
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Dec 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Cincinnati Childrens
Cincinnati, Ohio, 45229, United States
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Lurie Children's Hospital
Chicago, Illinois, 60611, United States
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