title: Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner.
abstract: OBJECTIVE
  To evaluate safety, weight loss, and cardiometabolic changes in obese subjects implanted with the duodenal-jejunal bypass liner (DJBL) for 1 year.
  
  
  BACKGROUND
  The DJBL is an endoscopic implant that mimics the duodenal-jejunal bypass component of the Roux-en-Y gastric bypass. Previous reports have shown significant weight loss and improvement in type 2 diabetes for up to 6 months.
  
  
  METHODS
  Morbidly obese subjects were enrolled in a single arm, open label, prospective trial and implanted with the DJBL. Primary endpoints included safety and weight change from baseline to week 52. Secondary endpoints included changes in waist circumference, blood pressure, lipids, glycemic control, and metabolic syndrome.
  
  
  RESULTS
  The DJBL was implanted endoscopically in 39 of 42 subjects (age: 36 ± 10 years; 80% female; weight: 109 ± 18 kg; BMI: 43.7 ± 5.9 kg/m); 24 completed 52 weeks of follow-up. Three subjects could not be implanted due to short duodenal bulb. Implantation time was 24 ± 2 minutes. There were no procedure-related complications and there were 15 early endoscopic removals. In the 52-week completer population, total body weight change from baseline was -22.1 ± 2.1 kg (P < 0.0001) corresponding to 19.9 ± 1.8% of total body weight and 47.0 ± 4.4% excess of weight loss. There were also significant improvements in waist circumference, blood pressure, total and low-density lipoprotein cholesterol, triglycerides, and fasting glucose.
  
  
  CONCLUSIONS
  The DJBL is safe when implanted for 1 year, and results in significant weight loss and improvements in cardiometabolic risk factors. These results suggest that this device may be suitable for the treatment of morbid obesity and its related comorbidities. This study was registered at www.clinicaltrials.gov (NCT00985491).
authors.affiliation: Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile. aescalon@med.puc.cl
authors.forename: Alex
authors.initials: A
authors.lastname: Escalona
authors.forename: Fernando
authors.initials: F
authors.lastname: Pimentel
authors.forename: Allan
authors.initials: A
authors.lastname: Sharp
authors.forename: Pablo
authors.initials: P
authors.lastname: Becerra
authors.forename: Milenko
authors.initials: M
authors.lastname: Slako
authors.forename: Dannae
authors.initials: D
authors.lastname: Turiel
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Muñoz
authors.forename: Claudia
authors.initials: C
authors.lastname: Bambs
authors.forename: Sergio
authors.initials: S
authors.lastname: Guzmán
authors.forename: Luis
authors.initials: L
authors.lastname: Ibáñez
authors.forename: Keith
authors.initials: K
authors.lastname: Gersin
mesh_terms: D000328:Adult; D050110:Bariatric Surgery / Q000295:instrumentation*; D003924:Diabetes Mellitus, Type 2 / Q000601:surgery; D004386:Duodenum / Q000601:surgery; D005260:Female; D006331:Heart Diseases / Q000503:physiopathology / Q000601:surgery; D006801:Humans; D007583:Jejunum / Q000601:surgery; D008297:Male; D008659:Metabolic Diseases / Q000503:physiopathology / Q000601:surgery*; D008875:Middle Aged; D009767:Obesity, Morbid / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D015431:Weight Loss