Abstract
Background
Duodenojejunal bypass liner (DJBL) is an endoscopic, reversible bariatric procedure resulting in weight loss and metabolic co-morbidities improvements in the adults.
Objectives
To determine safety and effectiveness of 12-month treatment with DJBL in adolescents with severe obesity (BMI > 35 kg/m2) and co-morbidities.
Methods
Post-pubertal subjects were treated with DJBL in an open-label, prospective clinical trial (NTC0218393). They were examined at 3 monthly intervals during the 12 months of DJBL treatment and 12 months of follow-up.
Results
DJBL was successfully placed in 19/22 adolescents (13 females, mean age (95%CI); 17.3 (16.7–17.9) years, BMI-SDS 3.7 (3.6–3.9)). There were no serious device-related adverse effects. Clinically relevant percent total weight loss (%TWL) (mean (95%CI)) 11.4 (7.4–15.3) % and BMI decrease − 4.9 (− 2.4 to − 7.4) kg/m2 was observed at DJBL removal (n = 19). At 12 months after device removal, %TWL was 4.1 (− 2.6–10.8) % and BMI decrease − 2.6 (0.2 to − 5.4) kg/m2 when compared with values at baseline (n = 13). HOMA-IR (− 2.1 (− 3 to − 1.3), WBISI 1.15 (0.23 to 2.07), total cholesterol, LDL-c, and triglycerides levels also improved during DJBL treatment and relapsed similarly to weight at 12-month follow-up. A decrease in iron stores, Zn, and Se levels was determined during DJBL treatment and spontaneously improved at follow-up.
Conclusions
Twelve months of DJBL treatment was safe and effective in adolescents with morbid obesity. Weight regain following device removal and relapse of metabolic complications should be expected.
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Acknowledgments
Authors thank all the participating adolescents and their families for their commitment to the study protocol. We thank all members of the endoscopic bariatric team, especially Tomaž Poredoš, dietitian and Simona Klemenčič, psychologist for their dedicated work. Authors also thank radiologist Dr. Martin Thaler for performing and evaluating the ultrasonographic images of the liver. Devices used were kindly provided by GI Dynamics Inc., Lexington, MA, USA.
Funding
Study was supported by the Slovenian Research Agency grants P3-0343 and J3-6798 and the University Medical Centre Ljubljana grant No. 20100364.
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The authors declare that they have no conflict of interest.
Ethical Approval
The trial was conducted according to the principles of good clinical practice and the Declaration of Helsinki with amendments. The study was approved by The Republic of Slovenia National Medical Ethics Committee (#39/03/14) and by the Competent Authority, and registered at www.clinicaltrials.gov (NCT02183935).
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Homan, M., Kovač, J., Orel, R. et al. Relevant Weight Reduction and Reversed Metabolic Co-morbidities Can Be Achieved by Duodenojejunal Bypass Liner in Adolescents with Morbid Obesity. OBES SURG 30, 1001–1010 (2020). https://doi.org/10.1007/s11695-019-04279-4
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DOI: https://doi.org/10.1007/s11695-019-04279-4