Comparing surgery and medical treatment for youth with type 2 diabetes
Surgical or Medical Treatment for Pediatric Type 2 Diabetes
PHASE4 · Children's Hospital Medical Center, Cincinnati · NCT04128995
This study is testing if a type of weight-loss surgery works better than medical treatment for helping teenagers with type 2 diabetes manage their blood sugar and improve their health.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 13 Years to 19 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT04128995 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether metabolic bariatric surgery, specifically vertical sleeve gastrectomy (VSG), is more effective than advanced medical therapy (AMT) in managing glycemic control and reducing co-morbidities in adolescents with type 2 diabetes. The trial will involve 90 participants aged 13 to 19.9 years, comparing the outcomes of VSG against AMT. The study addresses the unique pathophysiology of youth-onset type 2 diabetes, which differs from adult cases, and seeks to explore innovative treatment options that could lead to better health outcomes for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13-19.9 years diagnosed with type 2 diabetes who meet specific inclusion criteria.
Not a fit: Patients with type 1 diabetes, certain genetic forms of diabetes, or those with chronic conditions that may interfere with study participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for adolescents with type 2 diabetes, potentially leading to improved long-term health outcomes.
How similar studies have performed: Initial small studies have shown promising results for bariatric surgery in youth with type 2 diabetes, but this study aims to provide definitive evidence on its effectiveness compared to medical therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 2 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
- Lurie Children's Hospital — Chicago, Illinois, United States (ACTIVE_NOT_RECRUITING)
- Cincinnati Childrens — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Amy S Shah, MD MS — Cincinnati Childrens Hospital Medical Center
- Study coordinator: Amy S Shah, MD
- Email: amy.shah@cchmc.org
- Phone: 513-636-4744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate