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Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial.
Ruban, A, Miras, AD, Glaysher, MA, Goldstone, AP, Prechtl, CG, Johnson, N, Chhina, N, Al-Najim, W, Aldhwayan, M, Klimowska-Nassar, N, et al
Annals of surgery. 2022;(3):440-447
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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.
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Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial.
Ruban, A, Prechtl, CG, Glaysher, MA, Chhina, N, Al-Najim, W, Miras, AD, Smith, C, P Goldstone, A, Patel, M, Moore, M, et al
BMJ open. 2019;(11):e032439
Abstract
Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.
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A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus.
Glaysher, MA, Mohanaruban, A, Prechtl, CG, Goldstone, AP, Miras, AD, Lord, J, Chhina, N, Falaschetti, E, Johnson, NA, Al-Najim, W, et al
BMJ open. 2017;(11):e018598
Abstract
INTRODUCTION The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight. METHODS AND ANALYSIS In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18-65 years with a body mass index 30-50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58-97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression. TRIAL REGISTRATION NUMBER ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.
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Efficacy and safety of insulin glargine compared to other interventions in younger and older adults: a pooled analysis of nine open-label, randomized controlled trials in patients with type 2 diabetes.
Pandya, N, DiGenio, A, Gao, L, Patel, M
Drugs & aging. 2013;(6):429-38
Abstract
OBJECTIVE Elderly patients with type 2 diabetes mellitus (T2DM) present therapeutic challenges related to co-morbidities, treatment adherence, and safety. This study examines the efficacy and safety of insulin glargine compared to other glucose-lowering interventions in younger and older adults. METHODS In this pooled analysis of 24-week data from nine prospective open-label, multicenter, phase 3/4, two-arm, parallel-group, randomized controlled trials, patients with T2DM aged 18-80 years received insulin glargine (used as a basal insulin regimen) or comparators (including rosiglitazone, pioglitazone, insulin lispro, insulin lispro 75/25, NPH insulin, NPH insulin 30/70, and lifestyle/dietary measures). Endpoints included change from baseline to week 24 in: glycated hemoglobin; fasting plasma glucose; body weight; body mass index; insulin dose; incidence of nocturnal, daytime, or any hypoglycemia. Results were stratified by age (<65, ≥65, 65-74, and ≥75 years) and treatment (insulin glargine or comparator). RESULTS A total of 2,938 patients were included (2,263 aged <65 years, 675 aged ≥65 years). Similar levels of glycemic control were achieved in both younger (<65 years) and older (≥65 years) patients with T2DM. Insulin glargine was associated with better glycemic control and a reduced incidence of daytime and any hypoglycemia versus comparator interventions in both younger and older T2DM patients. CONCLUSION This analysis suggests that insulin glargine may represent a safe option to improve glycemic control in older patients with T2DM.