title: Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner.
abstract: BACKGROUND
  The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes.
  
  
  METHODS
  Twenty-two subjects (mean age, 46.2±10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8±7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study.
  
  
  RESULTS
  Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9±3.2 weeks. Reasons for early removal of the device included device migration (n=3), gastrointestinal bleeding (n=1), abdominal pain (n=2), principal investigator request (n=2), and discovery of an unrelated malignancy (n=1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3±10.2 mg/dL), fasting insulin (-7.3±2.6 μU/mL), and HbA1c (-2.1±0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c<7% compared with only one of 22 at baseline. Upper abdominal pain (n=11), back pain (n=5), nausea (n=7), and vomiting (n=7) were the most common device-related adverse events.
  
  
  CONCLUSIONS
  The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.
authors.affiliation: Gastrointestinal Endoscopy Unit, University of São Paulo Medical School, São Paulo, Brazil. eduardoghdemoura@gmail.com
authors.forename: Eduardo G H
authors.initials: EG
authors.lastname: de Moura
authors.forename: Bruno C
authors.initials: BC
authors.lastname: Martins
authors.forename: Guilherme S
authors.initials: GS
authors.lastname: Lopes
authors.forename: Ivan R
authors.initials: IR
authors.lastname: Orso
authors.forename: Suzana L
authors.initials: SL
authors.lastname: de Oliveira
authors.forename: Manoel P
authors.initials: MP
authors.lastname: Galvão Neto
authors.forename: Marco A
authors.initials: MA
authors.lastname: Santo
authors.forename: Paulo
authors.initials: P
authors.lastname: Sakai
authors.forename: Almino C
authors.initials: AC
authors.lastname: Ramos
authors.forename: Arthur B
authors.initials: AB
authors.lastname: Garrido Júnior
authors.forename: Marcio C
authors.initials: MC
authors.lastname: Mancini
authors.forename: Alfredo
authors.initials: A
authors.lastname: Halpern
authors.forename: Ivan
authors.initials: I
authors.lastname: Cecconello
mesh_terms: D050110:Bariatric Surgery / Q000379:methods*; D001786:Blood Glucose / Q000378:metabolism*; D020878:Device Removal; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004386:Duodenum / Q000601:surgery*; D004724:Endoscopy; D005260:Female; D006801:Humans; D007583:Jejunum / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood* / Q000601:surgery; D018579:Patient Selection; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose