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Active, Not Recruiting

NCT Number: NCT04128995

Surgical or Medical Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

Youth-onset type 2 diabetes (T2D) leads to early dependence on exogenous insulin and progression of T2D co-morbidities, including dyslipidemia, hypertension, non-alcoholic fatty liver disease and diabetic kidney disease. The pathophysiology of T2D in youth differs considerably from adults and current treatment approaches are in-adequate for youth. Thus, exploration of innovative approaches to reduce co-morbidities is critical. Metabolic bariatric surgery (MBS) significantly improves multiple outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass also suggest beneficial effects in youth with T2D, but definitive studies and understanding of mechanisms in youth-onset T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG).

We will test the hypothesis that VSG will be more effective in reducing glycemia and comorbidities than the best currently available medical treatment: advanced medical therapy (AMT), via pancreatic, enterohepatic and/or metabolic changes. To test this hypothesis, 90 adolescents with T2D will be studied to compare the effects of VSG vs. AMT on glycemic control and T2D-associated comorbidities, as well as underlying mechanisms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced Medical Therapy and Bariatric Surgery

Procedure

Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes

Advanced Medical Therapy

Drug

Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin for youth with type 2 diabetes

bariatric surgery

Procedure

Vertical Sleeve Gastrectomy for youth without type 2 diabetes

Other names: Vertical Sleeve Gastrectomy

Primary outcomes

  1. Glycemic Control

    Time frame: At one year

    Hemoglobin A1c of <6.5%

Secondary outcomes

  1. Glycemic Control

    Time frame: At two years

    Hemoglobin A1c <6.5% at 2 years

  2. Glycemic Variability

    Time frame: At one year

    Time In Range by Continuous Glucose Monitoring

  3. Beta Cell Function

    Time frame: at 1 and 2 years

    Oral disposition index= Insulin secretion [insulinogenic index] * insulin sensitivity [1/fasting insulin]

  4. Alpha cell function

    Time frame: at 1 and 2 years

    Glucagon area under the curve from mixed meal tolerance testing

  5. Incretin Response

    Time frame: at 1 and 2 years

    GLP-1 area under the curve from mixed meal tolerance testing

  6. Fatty Liver Disease

    Time frame: at 1 and 2 years

    Hepatic Fat (<5% )by Magnetic Resonance imaging

  7. Dyslipidemia

    Time frame: at 1 and 2 years

    LDL <130mg/dL

  8. Hypertension

    Time frame: at 1 and 2 years

    Blood pressure <130/80 mmHg

  9. Diabetic Kidney Disease

    Time frame: At 1 and 2 years

    Urinary albumin excretion <30μg/mg

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Children's Hospital Colorado

Registry information

Official study title

Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Acronym: ST2OMP

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2019
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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