A Preclinical Animal Study of Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner for Obesity and Metabolic Disease

Abstract

INTRODUCTION: Endoscopic bariatric and metabolic therapies can potentially reproduce similar gastric and small intestinal anatomic and physiologic manipulations as Roux-en-Y gastric bypass. This proof of concept animal study was aimed to assess the feasibility, safety, efficacy, and impact on gastrointestinal physiology of combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL) for the treatment of obesity. METHODS: Five Ossabaw pigs were fed a high-calorie diet to develop obesity and were randomly assigned to receive IGB or DJBL in sequence. The weight gain rate was calculated. Fasting and postprandial blood samples were drawn before any intervention (serving as the baseline group) and 1 month after second device insertion (serving as the combination group) to measure gut neurohormonal changes and metabolic parameters. RESULTS: Four pigs successfully received a sequential device insertion. One pig developed duodenal sleeve prolapse that was spontaneously resolved. One pig was early terminated because of developing a central line infection. The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone. A trend of higher postprandial glucagon-like peptide-1 was observed in the combination group compared with the baseline group. DISCUSSION: A combination of IGB and DJBL is feasible and well tolerated. A strategy of sequential use of these devices might offer a synergistic approach that can enhance weight loss and metabolic outcomes.

Future of Metabolic Endoscopy

“…For instance, one study assessed the efficacy of combined IGB and DJBL in an animal study. 44 The study reported a significantly lower rate of weight gain in the combination group (MD, 0.63 kg) compared with IGB alone and DJBL alone (MD, 1.00 and 0.75 kg, respectively). Other combination therapies could be potentially further studied, namely the conjunction of DMR with either ESG or POSE with the aim of enhancing the metabolic outcomes in patients with high-risk conditions such as T2DM or NASH.…”

Small intestine‐targeted endoscopic bariatrics: Current status and future perspectives

“…A preclinical animal study in pigs showed that the sequential insertion of IGB and DJBL resulted in significantly lower rates of weight gain than baseline, and in numerically lower rates of weight gain compared to the insertion of a single device. 56 The combination of the two devices also showed a trend towards higher postprandial GLP-1 levels. Furthermore, repeated implantation of small intestine-targeted EBMTs is another strategy that can be employed for achieving satisfactory longterm weight loss and metabolic improvement outcomes.…”

“…Combined implantation of gastric and small intestine‐targeted EBMTs is another promising strategy for improving weight loss and metabolic outcomes. A preclinical animal study in pigs showed that the sequential insertion of IGB and DJBL resulted in significantly lower rates of weight gain than baseline, and in numerically lower rates of weight gain compared to the insertion of a single device 56 . The combination of the two devices also showed a trend towards higher postprandial GLP‐1 levels.…”

Research Progress of Duodenal-Jejunal Bypass Liner in the Treatment of Obesity and Type 2 Diabetes Mellitus

“… 52 After implantation of the DJBL, when weight loss and blood glucose improvement reached the platform stage, adding other endoscopic weight loss technologies is advisable, covering gastric balloons to enhance the therapeutic effect. 53 , 54 Moreover, it is necessary to improve the anchor to mitigate damage to the intestinal wall of the anchor site. Simultaneously, the DJBL should be upgraded to prolong the service time of the device and provide longer-term treatment for patients.…”