PurposeThe objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics.Materials and MethodsThe AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0–70.0 kg/m2, were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m2.ResultsMean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics.ConclusionThis study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting.Trial RegistrationISRCTN 49958132Electronic supplementary materialThe online version of this article (10.1007/s11695-017-3096-5) contains supplementary material, which is available to authorized users.
BackgroundThis study evaluated the efficacy and safety of the novel AspireAssist® Aspiration Therapy System for treatment of obesity, and its effect on patient’s quality of life.MethodsA prospective observational study with 25 obese subjects, mean age 48 years (range 33–65), was performed. A custom gastrostomy tube (A-tube, Aspire Bariatrics) was percutaneously inserted during a gastroscopy performed under conscious sedation. Drainage and irrigation of the stomach were performed 3 times daily, 20 min after each meal, for 1–2 years. Efficient aspiration required thorough chewing of ingested food. Treatment included a cognitive behavioral weight loss program.ResultsMean body mass index (BMI) at inclusion was 39.8 kg/m2 (range 35–49). After 1 year mean (SD) BMI was 32.1 kg/m2 (5.4), p < 0.01, and excess weight loss was 54.4% (28.8), p < 0.01. Quality of life, as measured with EQ-5D, improved from 0.73 (0.27) to 0.88 (0.13), p < 0.01. After 2 years BMI was 31.0 kg/m2 (5.1), p < 0.01, and excess weight loss was 61.5% (28.5), p < 0.01. There were no serious adverse events or electrolyte disorders. Compliance was 80% after 1 year and 60% after 2 years.ConclusionsAspiration therapy is an efficient and safe treatment for obesity, and weight reduction improves quality of life. Excess weight was approximately halved in a year, with weight stability if treatment was continued.Trial registrationTrial Register ISRCTN 49958132. Retrospectively registered 28/02/2014.
In this study, substantial weight loss was achieved with few complications using the AspireAssist system, suggesting its potential as an attractive therapeutic device for obese patients. Trial Register ISRCTN 49958132.
BackgroundVery low calorie diet (VLCD) is routinely used in programs for treatment of obesity and before bariatric surgery in order to reduce risk of postoperative complications. Aspartame, an artificial sweetener, is commonly used in VLCD and is well approved as a food additive without any adverse effects. The development of a new fructose containing VLCD formula without aspartame raises questions as to effects on glucose and lipid control.MethodsAs part of an ongoing study of a novel bariatric surgery procedure, twenty-five obese subjects with mean body mass index (BMI) 39.8 kg/m2 and mean age of 48.8 years enrolled in a single center observational study. Seven subjects presented with type 2 diabetes mellitus. The subjects underwent four weeks dietary treatment with VLCD Slanka (Slanka®). Blood samples including fasting plasma glucose, HbA1c, cholesterol and triglycerides were performed at start and after four weeks of diet. Blood pressure and weight were noted.ResultsAll subjects completed the diet without any adverse events. Mean weight reduction was 8.2 kg with 95% confidence interval 7.1–9.2 kg (p = 0.001). Excess weight (i.e. proportion of weight exceeding BMI 25) loss decreased by median 19.5% (inter quartile range (IQR) 16,8-24,2). Median fasting plasma glucose was at inclusion 5,6 mmol/l (IQR 5,3-6,8) and after diet 4.8 mmol/l (IQR 4,6-5,2) (p = 0.001). Median HbA1c changed from 39 mmol/mol (IQR 37–44) to 37 mmol/mol (IQR 35–43) (p = 0.001). There was also significant reduction in cholesterol and triglyceride levels as well as in systolic blood pressure. Changes in other monitored blood chemistry values were without clinical importance.ConclusionFour weeks treatment with fructose containing VLCD of obese subjects preparing for bariatric surgery gave a substantial weight reduction without any significant negative metabolic effects.
The complication rate after the laparoscopic gastrostomy procedure was higher in our patient group, compared to previously studied children with various diseases. Comparisons regarding mean weight gain between the groups showed no significant differences. The mean weight gain was low, suggesting that the energy expenditure in this patient group of children with severe congenital heart disease may be even higher than previously assumed.
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