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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

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Treatment

Locations

Childrens Hospital Colorado
University of Colorado Hospital

Principal Investigator
Kristen Nadeau

Kristen Nadeau

Study ID

Protocol Number: 19-1978

More information available at ClinicalTrials.gov: NCT04128995

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