Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG. DESIGN: A priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2 (min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss. RESULTS: 36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2 was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2 remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG. CONCLUSION: ESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity. TRIAL REGISTRATION NUMBER: NCT03406975.

Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis.

BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Efficacy and Safety of Endoscopic Balloon Placement for Weight Loss in Patients With Cirrhosis Awaiting Liver Transplantation.

The efficacy and safety of a fluid-filled intragastric balloon (IGB) for weight loss in patients with cirrhosis on the liver transplantation (LT) waiting list is unknown. We enrolled stable compensated patients with body mass index >35 kg/m2 and on the waiting list for IGB placement endoscopically for a maximum of 6 months. A total of 8 patients (7 men) aged mean ± SD, 56 ± 4.6 years with Model for End-Stage Liver Disease-sodium (MELD-Na) scores 14.1 ± 3.4 experienced weight reduction (146 ± 22.2 kg versus 127 ± 21.6 kg [P = 0.005] with IGB in place and 130 ± 24.6 kg [P = 0.014] at 6 months), with a total body weight loss of 12.2% ± 8.8% with IGBs in place and 10.9% ± 8.9% at 6 months. Body fat decreased from 48.6% ± 5.8% to 40.6% ± 6.4% (P = 0.001) and lean mass increased from 51.3% ± 6% to 59.4% ± 6.4% (P = 0.001). No change in MELD-Na scores occurred (P = 0.770). Early balloon retrieval was attributed to accommodative symptoms (n = 2) and liver decompensation (n = 1). Mallory Weiss tears (n = 3), but no portal hypertensive bleeding, occurred. Liver decompensation and/or hepatocellular carcinoma (HCC) developed in 3 patients. A total of 4 patients with LT ± sleeve gastrectomy maintained overall weight loss. Of 4 patients who did not receive transplants, 2 experienced weight regain. IGB results in short-term weight loss in patients with cirrhosis awaiting LT, with body fat loss without lean mass loss. Adverse effects were common. Decompensation and HCC did occur, with uncertainty of the relation to weight loss, and thus careful patient selection and close follow-up are required.

Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.

BACKGROUND AND AIMS: Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS: Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS: 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4  kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION: When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.

Effectiveness of Online Aftercare Programs Following Intragastric Balloon Placement for Obesity Is Similar to Traditional Follow-up: a Large Propensity Matched US Multicenter Study.

BACKGROUND: The combination of intragastric balloons (IGB) with comprehensive lifestyle and behavioral changes is critical for ongoing weight loss. Many community and rural practices do not have access to robust obesity resources, limiting the use of IGBs. Online aftercare programs were developed in response to this need, delivering lifestyle coaching to maximize effectiveness. How these programs compare to traditional follow-up is currently unknown. METHODS: Using propensity scoring (PS) methods, two large prospective databases of patients undergoing IGB therapy were compared to estimate the difference in percent total body weight loss (%TBWL) between groups while identifying predictors of response. RESULTS: Seven hundred fifty-eight unique patients across 78 different participating practices (online n = 437; clinical registry n = 321) was analyzed. The mean %TBWL at balloon removal was 11% ± 6.9 with an estimated treatment difference (ETD) between online and traditional follow-up of - 1.5% TBWL (95% CI - 3-0.4%; p = 0.125). Three months post-balloon removal, the combined %TBWL was 12.2% ± 8.3 with an ETD of only 1% TBWL (95%CI - 3-3%; p = 0.08). On multivariable linear regression, each incremental follow-up was associated with increased %TBWL (ß = 0.6% p = 0.002). CONCLUSION: Online IGB aftercare programs provide similar weight loss compared with traditional programs. Increased lifestyle coaching whether in person or remotely is associated with more %TBWL at removal and during follow-up. Close follow-up for clinical symptoms is still warranted.

Medical Devices for Obesity Treatment: Endoscopic Bariatric Therapies.

Endoscopic bariatric therapies (EBTs) are effective tools for the management of obesity. By mimicking restrictive and bypass surgery physiology, they provide a safe and effective treatment option with the added capabilities of reaching a broader population. Multiple efficacious medical devices, such as intragastric balloons, endoscopic suturing/plication devices, and bypass liners, at various stages of development are available in the United States. EBTs represent the newest addition to a multidisciplinary approach in obesity management. This article reviews several devices' safety and efficacy for primary care providers in the era of evolving obesity treatment.

Maternal concerns about children overeating among low-income children.

Addressing overeating is essential to obesity treatment and prevention. The objectives of this study were to investigate maternal concern for child overeating, to identify associated participant characteristics and to determine if concern for child overeating is associated with maternal feeding practices. Low-income mothers (N=289) of children (mean age 70.8months) participated in a semi-structured interview. Themes of maternal concern for child overeating were identified and a coding scheme was reliably applied. Maternal feeding practices were measured by questionnaire and videotaped eating interactions. Logistic regressions were used to test the associations of participant characteristics with the presence of each theme, and bivariate analyses were used to test the associations of the presence of each theme with feeding practices. Three themes were identified: 1) mothers worry that their child does overeat, 2) mothers acknowledge that their child may overeat but indicate that it is not problematic because they manage their child's eating behavior, and 3) mothers acknowledge that their child may overeat but indicate that it is not problematic because of characteristics inherent to the child. Child obesity predicted the themes; mothers of obese and overweight children are more likely to be concerned about overeating. Themes were associated with lower levels of observed pressure to eat. Only Theme 2 was associated with greater restrictive feeding practices. Interventions that provide parents' practical, healthy ways to prevent child overeating may be helpful.