Key result
The duodenal-jejunal bypass liner did not significantly improve the rate of patients achieving a ≥20% reduction in glycated hemoglobin at 12 months (54.6% vs 55.2%; OR 0.93; 95% CI 0.44-2.0; P=0.85).
Why the study?
Endoscopic interventions like the duodenal-jejunal bypass liner (DJBL) have emerged as alternatives to metabolic surgery for patients who are ineligible or fearful of surgical risks, prompting an evaluation of its clinical efficacy and safety in T2DM and obesity.
Does the duodenal-jejunal bypass liner added to intensive medical care improve glycated hemoglobin reduction in adults with inadequately controlled T2DM and obesity?
RCT (n=170)
Open-label
randomized
Yes
Does the duodenal-jejunal bypass liner added to intensive medical care improve glycated hemoglobin reduction in adults with inadequately controlled T2DM and obesity?
Odds Ratio: 0.93 (95% CI 0.44–2)
Absolute Event Rate: 54.6% vs 55.2%
p-value: p=0.85
The addition of a duodenal-jejunal bypass liner to intensive medical care improved weight loss and cardiometabolic risk factors but did not significantly improve glycemia compared to medical care alone, and was associated with a higher rate of adverse events.
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.
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Ruban et al. (2022) conducted an RCT in Type 2 Diabetes Mellitus and Obesity (n=170). Duodenal-jejunal bypass liner (DJBL) vs. Intensive medical care without DJBL was evaluated on Percentage of participants achieving a glycated hemoglobin reduction of ≥20% at 12 months (OR 0.93, 95% CI 0.44-2.0, p=0.85). The duodenal-jejunal bypass liner did not significantly improve the rate of patients achieving a ≥20% reduction in glycated hemoglobin at 12 months (54.6% vs 55.2%; OR 0.93; 95% CI 0.44-2.0; P=0.85).
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