Duodenal-jejunal bypass liners may improve glycemic control in patients with diabetes

1. Duodenal-jejunal bypass liners were superior to sham in reducing HbA1c and improved weight loss in patients with uncontrolled type 2 diabetes mellitus.

2. Despite efficacious outcomes, duodenal-jejunal bypass liners raised safety concerns, including a high rate of hepatic abscess.

Evidence Rating Level: 1 (Excellent)

Study Rundown: A duodenal-jejunal bypass liner (DJBL) is a removable sleeve that extends into the jejunum from its endoscopic fixation point in the duodenal bulb. The DJBL works by physically shielding the intestinal lining from chyme, altering gut signaling in a manner believed to enhance glucose metabolism through increased GLP-1 secretion. The ENDO trial evaluated the safety and efficacy of the DJBL against a sham procedure in a randomized, double-blind, multicenter study, enrolling adults with uncontrolled type 2 diabetes mellitus (T2DM) and obesity. At 12 months, the DJBL group showed a significantly greater decrease in HbA1c, increased weight loss, improved systolic and diastolic blood pressure, and lowered triglycerides compared to the sham group. Albumin, iron, and ferritin levels also decreased significantly more in the DJBL group, although the delta in iron levels equalized between groups by 65 weeks post-implantation. This study’s strengths included its multicenter, double-blind, randomized, sham-controlled design, which minimized bias and strengthened the validity of the findings. However, the trial was terminated prematurely due to a higher-than-expected incidence of hepatic abscesses, which curtailed the duration of long-term follow-up. The occurrence of these adverse events also limited the device’s clinical applicability despite its metabolic benefits. The study’s exclusion of patients taking GLP-1 receptor agonists and protocol-driven medication adjustments may also limit the overall generalizability of this trial.

Click to read the study in Annals of Surgery

Relevant Reading: Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity

In-Depth [randomized controlled trial]: This study enrolled adults aged 21-65 years with obesity (BMI 30-55 kg/m²) and poorly controlled type 2 diabetes (HbA1c 7.5-10%) across 25 U.S. centers. Patients were randomly assigned in a 2:1 ratio to receive either a DJBL or a sham endoscopic procedure, with both groups undergoing standardized medical therapy and lifestyle counseling. The primary efficacy outcome was the change in HbA1c at 12 months, while the primary safety outcome was the rate of device-related serious adverse events requiring early device removal. Secondary outcomes included weight loss, cardiometabolic measures, and the proportion of patients achieving a change of ≥5% total weight loss or HbA1c ≤7%. Overall, 320 participants were included in the modified intention-to-treat analysis, with 212 assigned to the DJBL group and 108 to the sham group. After 12 months, patients treated with the DJBL experienced a significantly greater reduction in HbA1c than those who underwent the sham procedure (-1.10% vs. -0.28%; P = .0004), exceeding a predefined superiority threshold of 0.4%. Weight loss was also greater in the intervention group, with a mean total weight loss of 7.7% in the DJBL group compared with 2.1% in controls (P < .0001). Additionally, proportionally more patients in the DJBL arm achieved a HbA1c ≤7% (28.3% vs. 9.4%; P = .0003) and at least 5% total body weight loss (60.4% vs. 21.3%; P < .0001). Significant improvements in fasting glucose, systolic and diastolic blood pressure, triglyceride levels, BMI, and waist circumference were also demonstrated in the DJBL group. Reductions in HbA1c, fasting glucose, body weight, BMI, and waist circumference for patients in the DJBL group were sustained over time, remaining below baseline through 78 weeks of follow-up. The primary safety endpoint was also achieved, as device-related serious adverse events requiring early removal occurred in 9.0% of participants, below the predefined 15% threshold. However, hepatic abscesses developed in 3.3% of treated patients, leading to early termination of the trial despite all cases resolving with antibiotics or percutaneous drainage and no deaths or permanent complications. Overall, findings from this study suggest that the DJBL provides clinically meaningful improvements in glycemic control and weight loss beyond medical management alone, although concerns regarding hepatic abscess risk warrant further evaluation before widespread clinical implementation. 

Image: PD

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