Objective: Investigate the safety and efficacy of 6 months' duodenal-jejunal bypass liner (DJBL) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus (T2DM).
Background: The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine. This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM.
Methods: A multicenter randomized controlled trial was conducted. Seventy-seven patients with obesity and T2DM were included. Thirty-eight patients were randomized to 6 months' DJBL treatment in combination with dietary intervention (34 successfully implanted, 31 completed the study), 39 patients received only dietary intervention (controls, 35 completed the study). Total study duration for both groups was 12 months, including 6 months of post-DJBL removal follow-up.
Results: After 6 months, just before DJBL removal, the DJBL group had lost 32.0% [22.0%–46.7%] of their excess weight versus 16.4% [4.1%–34.6%] in the control group (P < 0.05). Glycated hemoglobin A1c levels improved to 7.0% [6.4%–7.5%] in the DJBL group and to 7.9% [6.6%–8.3%] in the control group (P < 0.05). In addition, 85.3% of DJBL patients showed decreased postprandial glucose excursions versus 48.7% of control patients (P < 0.05). At 12 months, excess weight loss of the DJBL group was 19.8% [10.6%–45.0%] versus 11.7% [1.4%–25.4%] in the control group (P < 0.05). HbA1c was 7.3% [6.6%–8.0%] versus 8.0% [6.8%–8.8%], DJBL versus control respectively (P = ns).
Conclusions: The DJBL is a safe and effective alternative to invasive bariatric procedures. Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone.
Exclusion of the proximal small intestine with the novel nonsurgical duodenal-jejunal bypass liner in combination with dietary intervention induces superior weight loss and rapid improvement of glycemic control in obese patients with type 2 diabetes in comparison with dietary treatment alone.
*Department of General Surgery, Rijnstate Hospital, Arnhem, The Netherlands
†Department of General Surgery and NUTRIM School for Nutrition, Toxicology and Metabolism Research, Maastricht University Medical Center, Maastricht, The Netherlands
‡Department of General Surgery, Atrium Medical Center Parkstad, Heerlen, The Netherlands.
Reprints: Jan Willem M. Greve, MD, PhD, Department of General Surgery, Atrium Medical Center Parkstad, PO Box 4446, 6401 CX Heerlen, The Netherlands. E-mail: firstname.lastname@example.org.
Disclosure: Supported by GI Dynamics, Inc (Lexington, MA). All data were collected under the supervision of MedPass (MedPass International, Paris, France). P. Koehestanie, N. D. Bouvy, I. M. Janssen, and J. W. M. Greve disclose the following financial relationships relevant to this publication: P. Koehestanie received consultancy fees from GI Dynamics, Inc; N. D. Bouvy and I. M. C. Janssen received an open research grant from GI Dynamics, Inc; and J. W. M. Greve received an open research grant, consultancy fees, and support for travel to meetings for the study or other purposes from GI Dynamics, Inc. C. de Jonge has no conflicts of interest relevant to this article.
Clinicaltrials.gov number: NCT00985114