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Background: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity., Methods: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160., Findings: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths., Interpretation: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance., Funding: Spatz Medical., Competing Interests: Declaration of interests BKA reports consultant roles with Endogenex, Endo-TAGSS, Metamodix, and BFKW; consultant and grant or research support from USGI, Cairn Diagnostics, Aspire Bariatrics, Boston Scientific; speaker roles with Olympus, Johnson and Johnson; speaker and grant or research support from Medtronic, Endogastric solutions; and research support from Apollo Endosurgery and Spatz Medical. CGC reports consultant roles with Olympus; consultant roles and payment or honoraria from Apollo Endosurgery and Boston Scientific; payment or honoraria from AbbVie; participation in a data safety monitoring board and consultant roles with Erbe, BFKW, and Nitinotes Surgical. VP reports consultancy fees from Obalon Therapeutics. PJ reports grants from Boston Scientific; patent licensed to Endosim; consulting fees from Endogastric solutions and Erbe; support for meetings from USGI medical; consulting fees and research support from Gastrointestinal Dynamics; and research support from Apollo Endosurgery and Fractyl. AA reports grants from the National Institutes of Health—National Institute of Diabetes and Digestive and Kidney Diseases, American Neurogastroenterology and Motility Society, Mayo Clinic Center for Individualized Medicine; stockholder of Gila Therapeutics and Phenomix Sciences; personal fees from Rhythm Pharmaceuticals, General Mills, Gila Therapeutics; and patent PCT/US62/589915 licensed to Phenomix Sciences. ACS reports institutional research grants from Boston Scientific, Enterasense, Endogenex; consulting fees from Olympus; consulting fees and research grants from Endo-TAGSS, and Apollo Endosurgery; participation in data safety monitoring board with Gastrointestinal Dynamics and Erbe. MR reports consultant roles with Boston Scientific, Fujifilm, Medtronic, Enterasense, and Gastrointestinal Windows; and consultant and research support from Cook Medical. DM reports financial support from Spatz Medical for statistical analysis for this trial. CCT reports institutional research grants from Aspire Bariatrics, Erbe, and Spatz Medical; royalties from Endosim and Enterasense; consulting fees and research grants from Apollo Endosurgery, Boston Scientific, Covidien/Medtronic, Fractyl, Fujifilm, Gastrointestinal Dynamics, Lumendi, Olympus, and USGI; payment or honoraria from Boston Scientific and Olympus; patents licensed to Boston Scientific, Gastrointestinal Windows, Enterasense, EnVision Endoscopy, and Endosim; participation in data safety monitoring board with Gastrointestinal Dynamics, Fractyl, and USGI; leadership or fiduciary role in other board with Enterasense, EnVision Endoscopy, Gastrointestinal Windows, American Society for Gastrointestinal Endoscopy governing board, and BlueFlame Healthcare Venture Fund; stockholder in Gastrointestinal Windows, Enterasense, EnVision Endoscopy; and has received equipment on loan from Fujifilm, Olympus, and Boston Scientific. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

The processing of proglucagon in intestinal L cells results in the formation of glucagon, GLP-1, and GLP-2. The GLP-1 molecule becomes active through the effect of proconvertase 1, and it is inactivated by dipeptidyl peptidase IV (DPP-IV), so that the half-life of endogenous GLP-1 is 2-3 min. GLP-1 stimulates insulin secretion from β cells in the islets of Langerhans. Human studies show that infusion of GLP-1 results in slowing of gastric emptying and increased fasting and postprandial gastric volumes. Retardation of gastric emptying reduces postprandial glycemia. Exendin-4 is a peptide agonist of the GLP-1 receptor that promotes insulin secretion. Chemical modifications of exendin-4 and GLP-1 molecules have been accomplished to prolong the half-life of GLP-1 agonists or analogs. This chapter reviews the effects of GLP-1-related drugs used in treatment of diabetes or obesity on gastric motor functions, chiefly gastric emptying. The literature shows that diverse methods have been used to measure effects of the GLP-1-related drugs on gastric emptying, with most studies using the acetaminophen absorption test which essentially measures gastric emptying of liquids during the first hour and capacity to absorb the drug over 4-6 h, expressed as AUC. The most valid measurements by scintigraphy (solids or liquids) and acetaminophen absorption at 30 or 60 min show that GLP-1-related drugs used in diabetes or obesity retard gastric emptying, and this is associated with reduced glycemia and variable effects on food intake and appetite. GLP-1 agonists and analogs are integral to the management of patients with type 2 diabetes mellitus and obesity. The effects on gastric emptying are reduced with long-acting preparations or long-term use of short-acting preparations as a result of tachyphylaxis. The dual agonists targeting GLP-1 and another receptor (GIP) do not retard gastric emptying, based on reports to date. In summary, GLP-1 agonists and analogs are integral to the management of patients with type 2 diabetes mellitus and obesity, and their effects are mediated, at least in part, by retardation of gastric emptying.

Transoral outlet reduction (TORe) is an incisionless, endoscopic procedure to address weight recurrence after Roux-en-Y gastric bypass. Given the chronic, progressive nature of obesity and the minimally invasive, anatomy preserving technique of TORe, the procedure is expected to be met with high patient acceptance and widening clinical adoption. Nevertheless, the approach to TORe has been heterogeneous. As endoscopic bariatric therapies are increasingly incorporated into the multidisciplinary management of obesity, it is crucial to have a standardized, evidence-based framework for their implementation. In this review, based on the available literature and the authors' combined experience of over 1,000 TORe procedures, we present our approach to patient selection, procedural technique, troubleshooting, and patient aftercare unique to TORe. [ABSTRACT FROM AUTHOR]

The prevalence of obesity has been increasing on a global scale. However, less than 1% of patients eligible for bariatric surgery actually undergo weight loss surgery. Endobariatric therapies (EBTs) have emerged to bridge the obesity treatment gap, as they are less invasive, highly effective, and more broadly applicable to patients with mild to moderate obesity. Endoscopic sleeve gastroplasty and primary obesity surgery endoluminal are the two most promising EBTs, altering stomach physiologies mimicking bariatric surgery. This review focuses on these two EBT approaches. [ABSTRACT FROM AUTHOR]

Obesity could increase the risk of Barrett's esophagus (BE). Roux-en-Y gastric bypass (RYGB) could alter the natural course of BE. Data on BE progression after RYGB are scarce. To study endoscopic surveillance and endoscopic eradication therapy (EET) outcomes of BE in post-RYGB patients versus controls with obesity. Academic referral centers, a retrospective cohort study. Patients who underwent RYGB with biopsy-proven BE or intramucosal esophageal adenocarcinoma (IM-EAC) with an endoscopic follow-up of at least 12 months were identified from a prospectively maintained database between January 1992 and February 2019 at 3 tertiary care centers. RYGB patients were matched 1-to-2 to patients with obesity (body mass index > 30 kg/m2) by the initial BE stage at diagnosis. Surveillance and EET outcomes were compared. A total of 147 patients were included (49 RYGB and 98 BE stage-matched controls with obesity). For endoscopic surveillance, the rate of disease progression to high-grade dysplasia /IM-EAC was significantly lower in the RYGB patients than controls (2.6% versus 40.2%, respectively; P <.0001), with a comparable median follow-up time (85 months versus 80 months, respectively). This effect persisted in a multivariate analysis, with a hazard ratio of.09 (95% confidence interval,.01–.69). For EET, no difference in the rate of achieving complete remission of intestinal metaplasia was observed between the RYGB and control groups (71.2% versus 81.3%, respectively; P =.44). RYGB appears to be a protective factor for disease progression to neoplastic BE during endoscopic surveillance. However, disease progression was still observed after RYGB, warranting continuing endoscopic surveillance. EET appeared to be equally effective between RYGB patients and controls with obesity. • Data on Barrett's esophagus (BE) progression after bariatric surgery is scarce. This study evaluated the outcomes in bariatric patients undergoing BE endoscopic surveillance or eradication therapy versus obese controls. • Roux-en-Y gastric bypass (RYGB) patients were less likely to progress to advanced BE on endoscopic surveillance than obese controls. • Endoscopic eradication therapy was equally effective in achieving complete remission of intestinal metaplasia between the RYGB and obese controls. [ABSTRACT FROM AUTHOR]

Background: The intragastric balloon (IGB) is commonly used for weight loss. Identifying patients who are most likely to tolerate and benefit from IGB therapy will optimize outcomes. Our aims were to prospectively utilize a gastric emptying study to predict intolerance and treatment response with a single fluid-filled IGB and to develop a physiologic prediction model with a treatment algorithm. Materials and Methods: A total of 32 patients had a gastric emptying study before and 2–3 months after placement of an IGB. Multiple logistic regression analyses were performed to calculate likelihood ratios and to develop a physiologic prediction model. Results: Patients in the higher gastric retention quartile at baseline had a 6.2-time higher likelihood ratio for early balloon removal secondary to intolerance (p = 0.013). Utilizing baseline gastric emptying to predict intolerance to the IGB may have prevented 75% of early removal cases. Decreased gastric emptying at 3 months after balloon placement was significantly correlated with percent total body weight loss (%TWBL) at 6 and 12 months (p = 0.01 and p = 0.014, respectively). At 6 months after IGB, patients with no change in their gastric emptying at 3 months lost significantly less weight compared with those with increased gastric retention (median %TBWL = 9.0% [4.5–14.7] versus 17.3% [12.2–24.4], p = 0.016). Conclusion: Utilizing gastric emptying as a physiologic predictor of intolerance and response to the single fluid-filled IGB can improve outcomes. This pilot feasibility trial ushers in the era of personalized endoscopic bariatric therapies to maximize patients' tolerance, cost-effectiveness, and meaningful weight loss. [ABSTRACT FROM AUTHOR]

The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P <.01). POSE 2.0 reduced maximum tolerated meal volume (P =.03) and was associated with increased fullness (P <.01) and improved eating behavior (P <.01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P <.01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. ClinicalTrials.gov Identifier: NCT03721731 [ABSTRACT FROM AUTHOR]

Obese patients with nonalcoholic steatohepatitis (NASH) are at risk for cirrhosis if significant weight loss is not achieved. The single fluid-filled intragastric balloon (IGB) induces meaningful weight loss and might be used in NASH treatment. We performed an open-label prospective study to evaluate the effects of IGB placement on metabolic and histologic features of NASH. Twenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m2) underwent magnetic resonance elastography (MRE) and endoscopic ultrasound with core liver biopsy collection at time IGB placement and removal at a single center from October 2016 through March 2018. The primary outcome measure was the changes in liver histology parameters after IGB, including change in nonalcoholic fatty liver disease activity score (NAS) and fibrosis score. We also evaluated changes in weight, body mass index, waist to hip ratio, aminotransaminases, fasting levels of lipids, fasting glucose, glycosylated hemoglobin, and MRE-detected liver stiffness. Six months after IGB, patients' mean total body weight loss was 11.7% ± 7.7%, with significant reductions in HbA1c (1.3% ± 0.5%) (P =.02). Waist circumference decreased by 14.4 ± 2.2 cm (P =.001). NAS improved in 18 of 20 patients (90%), with a median decrease of 3 points (range, 1–4 points); 16 of 20 patients (80%) had improvements of 2 points or more. Fibrosis improved by 1.17 stages in 15% of patients, and MRE-detected fibrosis improved by 1.5 stages in 10 of 20 patients (50%). Half of patients reached endpoints approved by the Food and Drug Administration of for NASH resolution and fibrosis improvement. Percent total body weight loss did not correlate with reductions in NAS or fibrosis. Other than post-procedural pain (in 5% of patients), no serious adverse events were reported. In a prospective study, IGB facilitated significant metabolic and histologic improvements in NASH. IGB appears to be safe and effective for NASH management when combined with a prescribed diet and exercise program. ClinicalTrials.gov no: NCT02880189 [ABSTRACT FROM AUTHOR]