Surgical or Medical Treatment for Pediatric Type 2 Diabetes
To compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.
Surgical or Medical Treatment for Pediatric Type 2 Diabetes (STOMP-T2D) is a prospective, open-label, controlled clinical trial funded by the National Institutes of Health for a period of 5 years. We propose to study 90 participants who are 13-19 years of age and have type 2 diabetes (T2D) at two sites Cincinnati Children’s Hospital & Children’s Hospital Colorado. We will compare glycemic control, co-morbidities and physiologic responses after vertical sleeve gastrectomy (VSG) vs. advanced medical therapy (AMT) at 1 and 2 years. STOMP-T2D will clarify whether VSG is more effective than AMT in promoting durable glycemic control, improved pancreatic β-cell function, and reduced co-morbidities in youth with T2D.
MoreChild to Adult
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 BMI ≥35 Willingness to take oral medications and/or diabetes SQ medications as medically indicated
Treatment
Childrens Hospital Colorado
University of Colorado Hospital
Kristen Nadeau, MD, MS
Protocol Number: 19-1978
More information available at ClinicalTrials.gov: NCT04128995
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