Can surgery beat diabetes in teens? new study investigates
NCT ID NCT03620773
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether weight-loss surgery (vertical sleeve gastrectomy) can improve kidney, heart, and pancreas function in teens aged 12-21 with type 2 diabetes and obesity. Researchers measured blood flow to the kidneys, kidney filtering ability, and insulin production before and after surgery. The goal is to see if surgery offers better long-term health than standard diabetes medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vertical sleeve gastrectomy (weight-loss surgery)
- What this could lead to
- If successful, this could show that weight-loss surgery helps control or even reverse type 2 diabetes in teens, reducing long-term complications.
- What could go wrong
- This is an early-phase study with only 24 participants, so results may not apply to everyone. Surgery carries risks like infection or nutritional deficiencies.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
24 people
The number who actually took part.
- Started
-
Oct 2018
- Finished
-
Sep 2024
- Lead sponsor
-
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
-
12 to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Obese youth with and without T2D (≥50 kg) scheduled for VSG * Weight \<550 lbs. * BMI ≥ 35 kg/m2 * Age 12-21 years * HbA1c ≤ 12% for participants with T2D, HbA1c \< 6.5% for participants with obesity Exclusion Criteria: * Obesity or T2D onset (diagnosis) \> 18 years of age * Prepubertal * Anemia * For participants undergoing the optional Parts 2-4 of visits 2 and 4, seafood or iodine allergy * Pregnancy or breastfeeding * Claustrophobia, implantable devices (MRI contraindications) * Recent diabetic ketoacidosis or hyperosmolar hyperglycemia * Other causes of diabetes other than T2D * For participants undergoing the optional Parts 2-4 of visits 2 and 4, diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone or probenecid, atypical antipsychotics or regular use of oral steroids Additional exclusion criteria for participants undergoing Visit 4 part 4, the optional kidney biopsy: * Evidence of bleeding disorder or complications from bleeding * Use of aspirin, NSAIDS or other blood thinner that cannot be safely stopped for a sufficient time period before and after the biopsy so as to add no additional risk of bleeding * Blood urea nitrogen (BUN) \> 80 gm/dL * INR \> 1.4 * PTT \> 35 seconds * Hemoglobin (Hgb) \< 10 mg/dL * Platelet count \< 100,000 / µL * Uncontrolled or difficult to control hypertension (\> 150/90 mmHg at the day of biopsy) * eGFR \< 40 mL/min/1.73m2 * Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy) * \> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter determined by ultrasound performed prior to the biopsy. * Kidney size: One or both kidneys \< 9 cm * Hydronephrosis or other important renal ultrasound findings such as significant stone disease * Any evidence of a current urinary tract infection as indicated on day of biopsy * Clinical evidence of non-diabetic renal disease * Positive urine pregnancy test or pregnancy
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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
-
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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