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Can surgery beat diabetes in teens? new study investigates

NCT ID NCT03620773

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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