Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST(2)OMP)

INTRODUCTION: The pathophysiology of type 2 diabetes (T2D) in youth differs from adults and conventional medical treatment approaches with lifestyle change, metformin, thiazolidinediones or insulin are inadequate. Metabolic bariatric surgery (MBS) improves multiple health outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass have also suggested beneficial effects in adolescents. Definitive studies in youth with T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG). The surgical or medical treatment for paediatric type 2 diabetes (ST(2)OMP) clinical trial was designed to test the hypothesis that VSG will more effectively reduce hyperglycaemic and diabetes comorbidities than the best currently available medical treatment incorporating state of the art pharmacotherapies. ST(2)OMP is also designed to better understand the pancreatic and enterohepatic mechanisms by which MBS improves diabetes and its associated comorbidities. METHODS AND ANALYSIS: ST(2)OMP is a prospective, open-label, controlled clinical trial that will recruit 90 postpubertal participants, age range 13–19.9 years, with body mass index ≥35 kg/m(2) or >120% of 95th percentile and youth-onset T2D. The primary outcome is the per cent of youth achieving haemoglobin A1c <6.0% at 12 months postgroup allocation (post-VSG vs postmedical group allocation). Secondary outcomes include remission of comorbidities and measures of β-cell and incretin responses at 12 and 24 months post VSG versus AMT. ETHICS AND DISSEMINATION: The ST(2)OMP protocol was approved by the Cincinnati Children’s Hospital Medical Center and the University of Colorado Institutional Review Boards. Written informed consent is obtained prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Clinical Trials.Gov NCT04128995.