Abstract
Objective:The aim of this study was to examine the clinical efficacy and safety of the duodenal-jejunal bypass liner (DJBL) while in situ for 12 months and for 12 months after explantation.Summary Background Data:This is the largest randomized controlled trial (RCT) of the DJBL, a medical device used for the treatment of people with type 2 diabetes mellitus (T2DM) and obesity. Endoscopic interventions have been developed as potential alternatives to those not eligible or fearful of the risks of metabolic surgery.Methods:In this multicenter open-label RCT, 170 adults with inadequately controlled T2DM and obesity were randomized to intensive medical care with or without the DJBL. Primary outcome was the percentage of participants achieving a glycated hemoglobin reduction of ≥20% at 12 months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24 months.Results:There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12 months [DJBL 54.6% (n = 30) vs control 55.2% (n = 32); odds ratio (OR) 0.93, 95% confidence interval (CI): 0.44–2.0; P = 0.85]. Twenty-four percent (n = 16) patients achieved ≥15% weight loss in the DJBL group compared to 4% (n = 2) in the controls at 12 months (OR 8.3, 95% CI: 1.8–39; P = .007). The DJBL group experienced superior reductions in systolic blood pressure, serum cholesterol, and alanine transaminase at 12 months. There were more adverse events in the DJBL group.Conclusions:The addition of the DJBL to intensive medical care was associated with superior weight loss, improvements in cardiometabolic risk factors, and fatty liver disease markers, but not glycemia, only while the device was in situ. The benefits of the devices need to be balanced against the higher rate of adverse events when making clinical decisions.Trial Registration:ISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04.
Highlights
The endoluminal duodenal-jejunal bypass liner (DJBL) is an innovative medical device developed and used for the treatment of adults with type 2 diabetes mellitus (T2DM) and/or obesity
There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12 months (DJBL 54.6% [n=30] vs. control 55.2% [n=32]; OR 0.93, 95% CI: 0.44, 2.0; p=.85). 24% (n=16) patients achieved ≥15% weight loss in the DJBL group compared to 4% (n=2) in the controls at 12 months
The DJBL group experienced superior reductions in systolic blood pressure, serum cholesterol and alanine transaminase at 12months
Summary
The endoluminal duodenal-jejunal bypass liner (DJBL) is an innovative medical device developed and used for the treatment of adults with T2DM and/or obesity. The aim underlying its conception and design was to mimic part of the impressive metabolic and weight loss effects of intestinal bypass surgical procedures such as the Roux-en-Y gastric bypass.[1] The DJBL consists of a single use impermeable fluoropolymer sleeve which is implanted in the duodenum endoscopically and lines 60 cm of the small intestine.[2] As a result food bypasses the proximal intestinal mucosa by traveling inside the sleeve and comes into contact with biliopancreatic secretions once it exits the sleeve. The device is normally implanted as a day case procedure under general anesthesia or sedation, and explanted electively after 12 months. It is an endoscopic treatment that could fill the large treatment gap between lifestyle/pharmacotherapy and metabolic surgery for T2DM and/or obesity.[2]
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