Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial
| Autor: | Anthony P. Goldstone, Ghadah Aldubaikhi, Harvinder Chahal, Christina G. Prechtl, Madhawi Aldhwayan, Hutan Ashrafian, Claire Smith, Emanuela Falaschetti, Michael A. Glaysher, Moaz Al-Lababidi, Lilliam Flores, Julian Teare, Ara Darzi, Georgios K Dimitriadis, Nicholas E. Johnson, Joanne Lord, Jonathan Cousins, Aruchuna Ruban, James P. Byrne, Ahmed R. Ahmed, Natalia Klimowska-Nassar, Mayank Patel, Michael Moore, Jia V. Li, Navpreet Chhina, Alexander D. Miras, Ben Glover, Werd Al-Najim, Carel W. le Roux |
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| Přispěvatelé: | National Institute for Health Research |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Duodenum law.invention Duodenal-jejunal bypass liner chemistry.chemical_compound Randomized controlled trial Jejunoileal Bypass law Weight loss Internal medicine medicine Humans Obesity Adverse effect 11 Medical and Health Sciences business.industry Type 2 Diabetes Mellitus Odds ratio Middle Aged medicine.disease Jejunum Treatment Outcome chemistry Diabetes Mellitus Type 2 Surgery Female Glycated hemoglobin medicine.symptom business RD RC |
| Zdroj: | King's College London |
| ISSN: | 1528-1140 0003-4932 |
| Popis: | 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 of 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. |
| Databáze: | OpenAIRE |
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