Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial.

Aruchuna Ruban, Alexander D Miras, Michael A Glaysher, Anthony P Goldstone, Christina G Prechtl, Nicholas Johnson, Navpreet Chhina, Werd Al-Najim, Madhawi Aldhwayan, Natalia Klimowska-Nassar, Claire Smith, Joanne Lord, Jia V Li, Lilliam Flores, Moaz Al-Lababidi, Georgios K Dimitriadis, Mayank Patel, Michael Moore, Harvinder Chahal, Ahmed R Ahmed, Jonathan Cousins, Ghadah Aldubaikhi, Ben Glover, Emanuela Falaschetti, Hutan Ashrafian, Carel W le Roux, Ara Darzi, James P Byrne, Julian P Teare

Journal: Annals of surgery 2022;275(3):440-447

PMID: 34647708

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Abstract

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.

Address: Department of Surgery and Cancer, Imperial College, London, UK.; Department of Metabolism, Digestion and Reproduction, Imperial College, London, UK.; Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.; PsychoNeuroEndocrinology Research Group, Centre for Neuropsychopharmacology, Division of Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Department of Brain Sciences, Imperial College London, Hammersmith Hospital, London, UK.; Imperial College London, Department of Public Health, Imperial Clinical Trials Unit, London, UK.; Diabetes Complications Research Center, University College Dublin, Ireland.; Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.; Southampton Health Technology Assessment Center, University of Southampton, Southampton, UK.; Section of Nutritional research, Department of Metabolism, Digestion and Reproduction, Imperial College London, UK.; Department of Endocrinology, King's College Hospital NHS Trust, London, UK.; University Hospital Southampton NHS Foundation Trust, Biomedical Research Center, Southampton, UK.; Primary Care, Population Sciences and Medical Education, University of Southampton Medical School, Southampton, UK.

DOI: 10.1097/SLA.0000000000004980

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MeSH Terms: Adult, Diabetes Mellitus, Type 2, Duodenum, Female, Humans, Jejunoileal Bypass, Jejunum, Male, Middle Aged, Obesity, Treatment Outcome