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Endobarrier removal linked to weight gain, worsened glycemic control
Patients treated with Endobarrier experienced weight gain and worsening glycemic control within a year after the device explantation, thus investigators recommended the development of a different strategy to preserve the treatment’s beneficial effects.
Endobarrier (duodenal-jejunal bypass liner [DJBL]; GI Dynamics) is an endoscopic implant that mimics the intestinal bypass component of Roux-en-Y gastric bypass to induce weight loss and improved glycemic control in patients with obesity and type 2 diabetes. It is approved and commercially available in several countries, but is currently limited to investigational use only in the U.S.
“This is the first study to present long-term follow-up after explantation of the DJBL,” investigators from Rijnstate Hospital in the Netherlands wrote. “It shows that after the loss of weight and improvement of diabetes parameters during implantation, there is a partial loss of benefit within 12 months after explantation.”
To study the consequences of DJBL explantation, the researchers performed a prospective observational study of 59 patients with type 2 diabetes who had the device implanted for at least 6 months and were followed for at least 1 year after the device was removed (mean age, 52 years; 46% women).
After implantation, patients lost an average of 11.6 kg at 6 months and 13.6 kg at 1 year, corresponding to a total body weight loss of 12.6% (P < .001). Twelve months after the device was explanted, mean weight gain was 5.6 kg, but body weight was still 8 kg lower on average than it was before implantation, for a net reduction in total body weight loss of 7.4% (P < .001).
“In total, 18 patients (31%) still had a net [total body weight loss] greater than 10% 12 months after explantation,” the researchers wrote.
Moreover, after implantation, mean HbA1c dropped from 65 to 61 mmol/mol (P = .039), but increased to the same level as baseline at 6 months after explantation, and by 12 months it increased from 65 to 70 mmol/mol (P = .025), which was significantly higher than before implantation.
The patients’ mean daily insulin dose remained unchanged after both implantation and explantation, but the number of patients on insulin remained significantly lower 12 months after explantation than before implantation (47% vs. 24%).
While duodenal endoscopic techniques including DJBL and duodenal mucosal resurfacing (DMR) “both carry great promise in the fight against diabetes and, to a lesser extent, obesity ... both are not-yet-finished therapeutic products at this stage of their development,” Simon K. Lo, MD, of Cedars-Sinai Medical Center and the David Geffen School of Medicine at UCLA, wrote in a related editorial. “A key issue is that they seem to lose their effects within a few months after the initial session. Hence, DJBLs may need to be implanted indefinitely, whereas DMRs may require periodic reapplication.”
Lo noted that it is unlikely that DJBLs will be approved in the U.S. in their current form, as a pivotal trial was terminated in 2015 due to high incidences of liver abscess. However, “it is conceivable that a modified version or placement method will be introduced here again in the future,” he added. – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.