The Surgical or Medical Treatment for Pediatric Type 2 Diabetes (ST2OMP) study is a prospective open label clinical trial comparing metabolic bariatric surgery (MBS) to AMT for teens with youth-onset T2D. Prior to study group assignment, youth participate in a 6-month run-in period and receive AMT defined as multidrug, treat-to-target medical therapy to achieve an HbA1c <6.5%. Here, we examine the effects of AMT on metabolic parameters during run-in on the initial 51 participants. Participants in ST2OMP (57% female, 30% Black, 38% Hispanic, 25% White) were a mean age of 16.8 years, median diabetes duration 1.1 years, and median HbA1c 6.5% at screening (49% with HbA1c <6.5%). During run-in, metformin or pioglitazone use alone decreased (35.3% to 31.4%), as did insulin use (37.3% to 31.4%), while use of SGLT-2 inhibitors or GLP-1 agonists alone, or dual or triple therapy without insulin increased (21.6% to 31.4%). There was a small decrease in BMI, triglycerides and ALT, but a small increase in systolic and diastolic BP and total cholesterol, and decrease in HDL. At completion of run-in, 49% had an HbA1c of <6.5%. During a 6-month run-in period, AMT, using alternatives to insulin resulted in reduced need for insulin with favorable effects in some metabolic parameters, without worsening glycemic control. Full cohort recruitment and two-year follow-up in ST2OMP will determine the benefits of AMT vs. MBS.
A.S.Shah: None. A.Bailey: None. T.Inge: None. M.Helmrath: None. K.J.Nadeau: None. M.M.Kelsey: Other Relationship; Boehringer Ingelheim Inc., Janssen Pharmaceuticals, Inc., Rhythm Pharmaceuticals, Inc., Lilly. T.M.Jenkins: None. L.R.Schaaf: None. S.Xanthakos: None. A.T.Trout: Consultant; Lantheus, General Electric Co., Research Support; Canon America Medical Systems, Siemens, Perspectum Ltd. A.Baumgartner: None. A.Riegler: None. N.Krishnan: None.
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK119450)
