Background: The duodenaljejunal bypass liner (DJBL) is an endoscopically placed and removable intestinal liner that creates a duodenaljejunal bypass. Weight loss and diabetes improvement was reported in the adults.
Objective and hypotheses: To evaluate clinical effects and safety of this device in severely obese adolescents with obesity complications.
Method: Six morbidly obese adolescents (four female, mean age 18.2 years (range 16.119.3), BMI 44.7 kg/m2 (range 40.448.8)) were included. Inclusion criteria were age >15 years, unsuccessful conservative therapy (<10% decrease in body weight) for >6 months, girls were not pregnant or planning pregnancy within next 12 months. All had prediabetes or type 2 diabetes and were receiving metformin, which was discontinued prior to DJBL placement. None had exclusion criteria described in detail at www.ClinicalTrials.gov (NCT02183935). DJBL was inserted under general anaesthesia, with no complications. Following the procedure subjects were symptomatically treated for nausea and abdominal pain and were discharged on day 2 post procedure. All were receiving esomeprazole 2×40 mg/day throughout follow up.
Results: In all a significant decrease in body weight and waist circumference was determined at 1 month (−7.4% (range −4.7 to −10.7) and −3.4 cm (range −3 to −7.5), respectively), continued to decrease at 3 months (−13.1% (range −8.6 to −19) and −10.5 cm (range −3 to −16)) and 6 months (−20.8% (range −20 to −21.7) and −18.5 cm (range −16.5 to −21.5)). In two subjects that completed 6 months of treatment glucose metabolism significantly improved (HOMA-IR decreased by −3.6 and 4.5, HbA1c by −2 and −0.5%), blood pressure normalized, liver steatosis and dyslipidemia improved (with the exception of decreased HDL). One subject developed cholecystitis 1 month post procedure and one had mildly elevated pancreatic enzymes concomitant to a gastrointestinal infection.
Conclusion: This is the first report on the use of endoscopically placed and removable DJBL in adolescents. In a limited number of subjects, being followed for up-to 6 months a significant loss of body weight with favorable metabolic outcome and no serious device-related side effects was observed.
Funding: This work was in part supported by grant number J3-6798 from the Slovenian Research Agency.
01 Oct 2015 - 03 Oct 2015