Aims: EndoBarrier is a 60 cm proximal intestinal liner, endoscopically implanted for up to 1 year, designed to mimic the bypass aspect of Roux-en-Y gastric bypass surgery. We aimed to assess its safety and efficacy in patients with advanced diabesity.Methods: Since October 2014 we have implanted 62 Endo-Barriers in our NHS service. By November 2018 all were explanted. Outcomes were monitored in a registry.Results: In 61 of the 62 patients (98.4%) (age 51.4±7.2 years, 54.1% male, 57.4% Europid, diabetes duration 12.0 (8.0–19.5) years, 57.4% insulin-treated, BMI 41.9±7.4 kg/m2) with implant and explant data, mean±SD HbA1c fell by 23.7±21.4 mmol/mol from 80.2±22.5 to 56.5±11.5 mmol/mol (p<0.001), weight fell by 15.9±8.5 kg from 122.6±27.9 to 106.7±28.9 kg (p<0.001), systolic blood pressure from 138.5±15.0 to 125.8±14.6 mmHg (p<0.001), cholesterol from 4.7±1.4 to 3.9±0.9 mmol/L (p<0.001) and alanine aminotransferase (a marker for non-alcoholic fatty liver disease) from 33.2±19.8 to 19.5±11.4 U/L (p<0.001). In the 35 insulin-treated patients, median (IQR) insulin dose reduced from 100 (54–140) to 40 (0–70) units (p<0.001), with 10/35 (28.6%) discontinuing insulin. There were significant falls (UKPDS Risk Engine v2) in the risk of coronary heart disease (CHD) and stroke, suggesting that EndoBarrier treatment in 100 such patients could prevent 8 events of CHD or stroke and save 6 lives over the 10 years. Ten of the 62 patients (16%) required early removal (4 for gastrointestinal haemorrhage, 2 for liver abscess, 1 for another intra-abdominal abscess and 3 for gastrointestinal symptoms). All made a full recovery following device removal and most derived benefit despite early removal.Conclusion: EndoBarrier was highly effective in this setting in patients with advanced diabetes and obesity. Given the high cardiovascular and microvascular risk of these patients, benefits might outweigh risks. As an endoscopic procedure it is relatively simple and non-invasive. Early removal rates require monitoring and there needs to be increased focus on preventing complications but, on balance, EndoBarrier deserves further investigation as a potential treatment for wider use.
Endocrine dysfunction in thalassaemia is amongst the most common complication and is principally attributed to excessive iron overload and suboptimal chelation. The prevalence is quite high particularly in multiethnic populations but determining the prevalence is often difficult due to the widespread heterogeneity of the population and timing of exposure to chelation therapy. Disturbances in growth, pubertal development, abnormal gonadal functions, impaired thyroid, parathyroid and adrenal functions, diabetes and disorderly bone growth are commonly encountered. Early detection and institution of appropriate transfusion regimen and chelation therapy and treatment of complications are the keys to managing this population including regular follow. In this article, we review the literature in relation to the various endocrine complications encountered in thalassaemia.
Aims: EndoBarrier is a 60 cm duodenal–jejunal bypass liner endoscopically implanted for up to one year. It mimics the bypass part of Roux-en-Y bariatric surgery and reduces weight and HbA1c while it is in situ. We aimed to assess the extent to which these improvements are sustained in people with diabetes in the year following removal.Methods: Between October 2014 and November 2017 we implanted 62 EndoBarriers in an NHS service with all removed by November 2018. Outcomes were monitored in a registry.Results: By November 2019, 46/62 (72%) (mean±SD age 51.5±7.7 years, 52% male, 54.3% white ethnicity, median (IQR) diabetes duration 14.5 (8–20) years, 67.4% insulin-treated and mean±SD body mass index (BMI) 41.6±7.1 kg/m2) had attended and 16/62 (28%) did not attend their one-year post-EndoBarrier follow-up appointment. In those who attended, during EndoBarrier implantation mean±SD HbA1c fell by 21.1±19.6 mmol/mol from 77.1±20.0 to 56.0±11.2 mmol/mol (p<0.001) (by 1.9±1.8% from 9.2±1.8% to 7.3±1.0% (p<0.001)), weight fell by 17.2±8.8 kg from 121.9±29.4 kg to 104.7±30.1 kg (p<0.001), BMI fell from 41.6±7.5 to 35.5±7.5 kg/m2 (p<0.001), systolic blood pressure from 139.0±14.0 to 126.0±14.6 mmHg (p<0.001) and serum alanine aminotransferase from 30.0±16.9 to 18.8±11.0 U/L (p<0.001). Median (IQR) total daily insulin dose reduced from 104 (54–162) to 30 (0–62) units (n=31, p<0.001); 10/31 (32%) insulin-treated people with diabetes were able to discontinue insulin. One year post-EndoBarrier, 18/46 (39%) demonstrated fully sustained improvement, 18/46 (39%) partially sustained improvement and 10/46 (22%) reverted to baseline. Of those deteriorating, 9/10 (90%) had depression and/or bereavement; they also had less fall in weight and HbA1c during EndoBarrier treatment. In the 16/62 (28%) who did not attend follow-up, reasons for non-attendance were too far to travel (25%), need to take time off work (6.3%), severe depression (6.3%) and death (6.3%). In 56.3% of cases no reason was given.Conclusion: Our data demonstrate that EndoBarrier is highly effective in people with long-standing poorly controlled type 2 diabetes and obesity, with maintenance of significant improvement one year after removal in 78% of cases for whom data were available. As an endoscopic procedure it is relatively simple and non-invasive and it deserves further investigation.
A 44‐year‐old South Asian woman, with type 2 diabetes requiring insulin, presented with multiple syncopal episodes. Her diabetes was complicated by peripheral neuropathy, diabetic retinopathy and nephropathy. She also had features of autonomic neuropathy. Short synacthen test ruled out adrenal insufficiency; thyroid function was normal. HbA1c was elevated at 14.6% (136mmol/mol). Abdominal computed tomography showed grossly dilated bladder (9.5cm x 14cm x 17.5cm), compressing the mid‐ureter. The size suggested an on‐going chronic process, consistent with diabetic cystopathy.An indwelling urethral catheter relieved the bladder distension and the patient was later successfully educated to void the bladder by the clock rather than bladder sensation. Euglycaemia was achieved with twice‐daily pre‐mixed analogue insulin.Diabetic cystopathy is an under‐diagnosed complication of diabetes. Most contemporary investigators believe that the aetiology is multifactorial, including disturbances of the bladder detrusor muscle, urethra, autonomic nerves and perhaps the urothelium. This most troublesome of all the genitourinary complications of diabetes is often overlooked. Copyright © 2011 John Wiley & Sons.
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