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Surgical or Medical Treatment for Pediatric Type 2 Diabetes

Primary Objective

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.

Study category: Diabetes & Hormone Disorders

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Description

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.

Details
Age

Child to Adult

Eligibility

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

Type of Study

Treatment

Locations

Childrens Hospital Colorado
University of Colorado Hospital

Principal Investigator
Kristen Nadeau,  MD, MS

Kristen Nadeau, MD, MS

Study ID

Protocol Number: 19-1978

More information available at ClinicalTrials.gov: NCT04128995

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