MILEPOST Multicenter Randomized Controlled Trial: 12 Month Weight Loss and Satiety Outcomes After poseSM vs. Medical Therapy
BackgroundPoseSM is an endolumenal weight loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.MethodsSubjects with classes I II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control) Pose subjects received gastric fundus and distal body suture anchor plications with diet/exercise counseling. Total body %TBWL) and excess weight loss %EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12 month %TBWL. Satiety changes were assessed at 6 and 12 months.ResultsFrom November 2013 to July 2014, 44 subjects were randomized (34, 77.3 female; mean age, 38.3 10.7 years; body mass index, 36.5 3.4 kg/m2) to pose (n 34) or control (n 10) groups in three centers. Mean pose procedure time was 51.8 14.5 min; pose subjects received a mean 8.8 1.3 fundal and 4.2 0.7 distal body plications. Twelve month TBWL: pose, 13.0 (EWL, 45.0 n 30 vs. control group, 5.3 (18.1 n 9; significant mean difference, 7.7 (95 CI 2.2, 13.2; p 0.01) Pose subjects showed significant reductions in satiety parameters (p 0.001) controls experienced reduced caloric intake and satiety volume (p 0.05) No serious device or procedure related adverse events occurred.ConclusionsIn a randomized controlled trial at 12 months, pose treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.Study registration: clinicaltrials.gov identifier NCT01843231
Obesity Surgery