PTH-003 Endobarrier®: a safe and effective novel treatment for obesity and type 2 diabetes?


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Abstract

IntroductionObesity is a modern pandemic. One of the major complications of obesity is the development of diabetes which leads to considerable mortality, morbidity and enormous health care costs.1The EndoBarrier is an endoscopically implantable duodenal-jejunal sleeve bypass (DJSB); anchored in the duodenum, preventing ingested food from coming into contact with the proximal intestine and induces weight loss and improvement in glycaemic control. The aim of this prospective study was to assess the safety and efficacy of the EndoBarrier in obese patients with type 2 diabetes.MethodThis was a non-randomised study conducted at three investigational sites (Southampton, London, and Manchester) over an 18 month period with clinical and biochemical assessments carried out at 3 monthly intervals. The device was implanted for 12 months with 6 months follow up. All patients were obese with poorly controlled diabetes. Adverse events were recorded and statistical analysis was performed.ResultsA total of 45 subjects were enrolled into the studyAt 12 months following implant:1) HbA1c significantly reduced from baseline at 0.8% below the mean at baseline (95% CI 0.1–1.6; p<0.05).2) Mean weight loss was 15 kg (95% CI 0.62–29.38; p<0.05)3) BMI was reduced by 4.9kg/m2 (95% CI 1.1–8.7; p<0.005).14 patients withdrew from the study, 6 required premature EndoBarrier removal. Of these, only 2 patients presented with device related complications (device migration and gastrointestinal bleeding), the others withdrew due to unrelated medical adverse events.ConclusionThe EndoBarrier appears to be a safe and effective treatment strategy in those who are overweight and have poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery. Larger randomised controlled trials with longer follow-up periods post-explant of the device need to be performed to investigate the device’s effects on long term glycaemic control and weight.ReferenceControl C. f. D. & Prevention. Prevalence of overweight and obesity among adults with diagnosed diabetes-United States, 1988–1994 and 1999–2002. MMWR. Morbidity and mortality weekly report2004;53:1066.Disclosure of InterestNone Declared

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