Effect of Glucagon-Like Peptide-1 Receptor Agonists on Bowel Preparation for Colonoscopy.

INTRODUCTION: Inadequate bowel preparation can result in decreased diagnostic accuracy and therapeutic safety of colonoscopy for colon cancer screening. The Boston Bowel Preparation Scale (BBPS) has been used to assess the quality of bowel preparation. Glucagon-like peptide-1 receptor agonists (GLP-1RA) are commonly used medications for diabetes mellitus and obesity that are known to delay gastrointestinal motility. We hypothesized that the use of GLP-1RA would be associated with decreased quality of bowel preparation. METHODS: We performed a retrospective cohort study of patients who underwent screening or surveillance colonoscopy at a large academic medical center between December 2021 and December 2022. We included patients taking any GLP-1RA for diabetes or obesity during colonoscopy defined as our cases, and patients who were prescribed GLP-1RA at one point but not within 3 months of colonoscopy defined as our controls. We excluded patients on any promotility or antimotility agents and those without BBPS recorded on their procedure report. Independent t test assessed statistical differences in the case and control groups to compare the quality of bowel preparation for continuous variables, and the χ 2 test was used for categorical variables. Multivariate linear regression including diabetes as a covariate was also performed for continuous variables, and multivariate logistic regression was performed for categorical variables. RESULTS: A total of 446 patients were included in the study, comprising 265 (59%) cases and 181 controls (41%). There were no statistically significant differences between groups at baseline except for the diagnosis of diabetes ( P = 0.001) with a higher proportion of patients with diabetes in the cases. The mean BBPS was significantly higher in controls (7.0 ± 1.9 vs 7.5 ± 2.4, P = 0.046) when controlling for diabetes. The percentage of patients with a total BBPS score of <5 was significantly higher in cases (15.5% vs 6.6%, P = 0.01). The proportion of patients who required a repeat colonoscopy due to poor bowel preparation was also significantly higher in cases (18.9% vs 11.1%, P = 0.041). DISCUSSION: The use of GLP-1RA was associated with a statistically significantly lower quality of bowel preparation, with additional clinical significance given a notable difference in the need for a repeat colonoscopy. It will be essential to understand the cumulative effect of medications that may delay gastric emptying on the quality of bowel preparation to better understand the appropriate measures and counseling that need to be taken before undergoing outpatient colonoscopies.

Cumulative effect of obesity phenotypes on body weight and body mass index.

BACKGROUND: Obesity originates from an imbalance between energy intake and expenditure. Changes in energy intake components (satiation, postprandial satiety, emotional eating) and energy expenditure have been linked to obesity and are referred to as obesity phenotypes. We aim to study if these obesity phenotypes have a cumulative effect on body weight and body mass index (BMI). SUBJECT/METHODS: This is a cross-sectional study of adult patients with obesity (BMI > 30 kg/m2) who completed the validated tests to measure the obesity phenotypes. A total of 464 were included in this study. INTERVENTIONS/METHODS: We defined higher calories to fullness during an ad libitum meal as abnormal satiation, accelerated time to half gastric emptying with scintigraphy as abnormal postprandial satiety, higher anxiety score on the Hospital Anxiety and Depression Scale as hedonic eating behavior, and decreased percentage of measured resting energy expenditure as abnormal energy expenditure. The primary analysis was done on the number of phenotypes ( ≤ 1 and ≥ 2) with body weight and BMI using an independent t-test. RESULTS: Our cohort included 464 patients (mean [SD] age 42.0 [10.9] years, 79% females, weight 111.2 [22.9] kg, BMI 38.9 [7.0] kg/m2). There were 294 patients who had ≤ 1 phenotype, and 170 patients with ≥ 2 phenotypes with no baseline demographical differences (i.e., age and sex). Having ≥ 2 phenotypes was associated with higher body weight (115 [25] kg vs. 109 [21] kg; p = 0.004), BMI (40 [8] kg/m2 vs. 38 [7] kg/m2; p = 0.02) and waist (118 [15] cm vs. 115 [13] cm; p = 0.04) and hip (129 [14] cm vs. 125 [13] cm; p = 0.01) circumferences compared to ≤ 1 phenotype. CONCLUSION: Obesity phenotypes are associated with an additive effect on the body weight and BMI. Patients who have multiple obesity phenotypes may require a more aggressive approach to enhance weight loss.

Weight loss and cardiovascular disease risk outcomes of semaglutide: a one-year multicentered study.

BACKGROUND/OBJECTIVE: There are limited real-world studies assessing semaglutide weight loss and associated comorbidity and metabolic outcomes over periods ≥ 6 months. We aim to assess weight loss, metabolic, and cardiovascular outcomes of 12 months of semaglutide. SUBJECT/METHODS: We conducted a multicentered retrospective cohort study on semaglutide use. We included patients with a body-mass index (BMI) ≥ 27 kg/m2 who were prescribed weekly semaglutide subcutaneous injections. We excluded patients with bariatric surgeries, taking other anti-obesity medications, and with active malignancy or pregnancy. A total of 1023 patients had semaglutide prescription for obesity. INTERVENTION/METHODS: We assessed weight loss outcomes of subcutaneous semaglutide for 12 months. The primary endpoint was total body weight loss percentage (TBWL%) at 12 months. Secondary endpoints included proportion of patients achieving ≥5%, ≥10%, ≥15%, and ≥20% weight loss, and improvements in metabolic, cardiovascular, and comorbidities after 12 months of follow-up. RESULTS: We included 304 patients (73% female, 93% White, mean age 48.8 [12.4] years, BMI 40.9 [9.6] kg/m2) in the analysis. Patients achieved a TBWL of 13.4 (8.0)% at 12 months (p < 0.001 from baseline). Patients without T2DM achieved a TBWL of 16.9 (6.9)% compared to 9.9 (8.4)% in patients without T2DM at 12 months on the higher doses of semaglutide (p < 0.001 from baseline). In this cohort, 81% achieved ≥5%, 64% achieved ≥10%, 41% achieved ≥15%, and 22% achieved ≥20% TBWL at 12 months. Patients with overweight or obesity experienced significant improvements in metabolic, lipid profile, blood pressure, liver function tests, and cardiovascular disease risk outcomes. CONCLUSIONS: Semaglutide demonstrated notable improvement in obesity, metabolic, and cardiovascular disease risk outcomes in a clinical setting.

The association between previous use of anti-obesity medication and semaglutide weight loss outcomes.

AIMS: To compare weight loss outcomes between patients starting semaglutide who had previously been on another anti-obesity medication (AOM) compared to those who were AOM-naïve. MATERIALS AND METHODS: We performed a retrospective study in patients with overweight or obesity taking semaglutide for weight loss for a duration of 3 to 12 months. Our primary endpoint was assessment of percentage of total body weight loss (TBWL) in patients who started semaglutide as their first AOM (AOM-naïve) compared to those who started semaglutide and had previously taken another AOM (non-AOM-naïve). The secondary outcome was a comparison of the proportions of patients achieving ≥5%, ≥10%, ≥15% and ≥20% TBWL between the groups. Our endpoints were analysed using independent t-tests and ANOVA/ANCOVA for continuous variables and Pearson's test for categorical variables. RESULTS: This study included 305 patients. Outcomes of semaglutide treatment were superior in AOM-naïve patients (n = 231) compared to non-AOM-naïve patients (n = 74) at 3 (6.3% vs. 3.8%), 6 (10.6% vs. 6.7%), 9 (14.0% vs. 9.1%) and 12 months (14.3% vs. 10.6%; p < 0.0001 at 3, 6 and 9 months, and p = 0.01 at 12 months). A greater proportion of patients in the AOM-naïve group achieved a TBWL ≥ 15% (48% vs 21%; p = 0.02) and ≥20% (27% vs 4% p < 0.01) at 12 months. CONCLUSION: The use of semaglutide in patients with previous intake of other AOMs was associated with inferior weight loss outcomes in comparison to patients who were AOM-naïve.

Applicant-Fellow Virtual Sessions in Recruitment for Gastroenterology Fellowship.

BACKGROUND: Since the COVID-19 pandemic in 2020, virtual interviews have become a norm for gastroenterology (GI) fellowship recruitment. Most interviews hold a session for applicant and current fellow interaction. There is wide variability of the sessions across programs. There are a paucity of data on the influence of these sessions on applicants' ranking of programs. AIMS: We aim to describe applicants' experiences and perceptions of virtual happy hours (i.e., applicant-fellow sessions) during the GI fellowship application process. METHODS: We surveyed applicants participating in the 2022 GI fellowship match cycle to understand their experience with virtual fellow-only happy hours. Mixed methods analyses were performed. RESULTS: The survey was completed by 68 (13.91%) applicants, of which, 75% reported that at least half of the interviews they attended had conducted a virtual, fellow-only happy hour. Most respondents preferred that the virtual happy hours should be conducted prior to the interview day (58%) and that breakout rooms with a smaller ratio of applicants to fellows are helpful (78%). The majority (87%) of respondents reported attending these sessions at least 75% of the time. Nearly half (44%) of respondents reported that these sessions influenced/altered their ranking decisions with respect to programs. CONCLUSION: Given the advantages associated with virtual interviews and their ongoing support by professional societies, the virtual platform is likely here to stay in future. Virtual fellow-only happy hours help provide a representation of the program's mission and when successfully implemented, can be leveraged to optimize recruitment and attract qualified, diverse candidates.

Improvements in hepatic steatosis, obesity, and insulin resistance in adults with nonalcoholic fatty liver disease after the primary obesity surgery endoluminal 2.0 procedure.

BACKGROUND: The primary obesity surgery endoluminal 2.0 (POSE 2.0) procedure involves full-thickness gastric body plications to narrow the stomach using durable suture anchor pairs. We evaluated POSE 2.0 as a treatment strategy for nonalcoholic fatty liver disease (NAFLD) in patients with obesity. METHODS: Adults with obesity and NAFLD were prospectively allocated based on their preference to undergo POSE 2.0 with lifestyle modification or lifestyle modification alone (control). Primary end points were improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary end points included %total body weight loss (%TBWL), change in serum measures of hepatic steatosis and insulin resistance, and procedure safety. RESULTS: 42 adult patients were included (20 in the POSE 2.0 arm and 22 in the control arm). At 12 months, POSE 2.0 significantly improved CAP, whereas lifestyle modification alone did not (P < 0.001 for POSE 2.0; P = 0.24 for control). Similarly, both resolution of steatosis and %TBWL were significantly higher with POSE 2.0 than with control at 12 months. Compared with controls, POSE 2.0 significantly improved liver enzymes, hepatic steatosis index, and aspartate aminotransferase to platelet ratio at 12 months. There were no serious adverse events. CONCLUSION : POSE 2.0 was effective for NAFLD in patients with obesity, with good durability and safety profile.

Baseline Characteristics and Predictive Factors of Intravenous Immunoglobulin Response in Drug and Device Refractory Gastroparesis Symptoms.

INTRODUCTION: Intravenous immunoglobulin (IVIG) has been shown in a small pilot series to be helpful for some patients with gastroparesis that is refractory to drugs, devices, and surgical therapies. Many but not all patients have serologic neuromuscular markers. We hypothesize that those patients with serologic markers and/or longer duration of therapy would have better responses to IVIG. MATERIALS AND METHODS: We studied 47 patients with a diagnosis of gastroparesis and gastroparesis-like syndrome that had all failed previous therapies including available and investigational drugs, devices, and/or pyloric therapies. Patients had a standardized 12-week course of IVIG, dosed as 400 mg/kg per week intravenously. Symptom assessment was done with Food and Drug Administration (FDA) compliant traditional patient-reported outcomes. Success to IVIG was defined as 20% or greater reduction in average symptom scores from baseline to the latest evaluation. RESULTS: Fourteen patients (30%) had a response, and 33 (70%) had no response per our definition. Patients responding had a higher glutamic acid decarboxylase 65 positivity (64% vs. 30%, P =0.049, missing=3) and longer duration of therapy (>12 wk/continuous: 86% vs. 48%, P =0.09). CONCLUSIONS: In this moderately sized open-label series of refractory patients with gastroparesis symptoms treated with IVIG, 30% of patients responded. While serologic markers and extended therapies show a trend to greater response, neither was statistically significant, except for glutamic acid decarboxylase 65 which showed a higher positivity rate in responders. We conclude that a clinical trial of IVIG may be warranted in severely refractory patients with gastroparesis symptoms.

Efficacy of Antiobesity Medications in Patients With Celiac Disease on a Gluten-free Diet: A Retrospective Matched Cohort Study.

GOALS: We aim to describe the weight loss outcomes of patients with celiac disease (CeD) taking antiobesity medications (AOMs) and compare it with the weight loss outcomes of patients without CeD taking AOMs. BACKGROUND: Increasing rates of obesity and obesity-associated comorbidities have been previously reported in patients with CeD on a gluten-free diet. The effectiveness of AOMs in this population has not been previously described. METHODS: In our retrospective cohort study, we matched 39 patients with treated CeD to 78 patients without CeD based on sex and AOM. We assessed the weight loss outcomes at 3, 6, and 12 months after starting the AOM in both cohorts and analyzed if there was a differential response when comparing by type of AOM [injectable glucagon-like peptide 1 (GLP-1) receptor agonists vs. oral non-GLP-1 AOMs]. RESULTS: Both cohorts had similar baseline demographic and anthropometric characteristics. At 12 months, the CeD cohort had a nonsignificantly inferior total body weight loss percentage compared with the cohort without CeD (6.5% vs. 9.5%, P=0.13). The CeD cohort had a similar proportion of patients achieving a total body weight loss percentage of ≥5% than the cohort without CeD (72.7% vs. 72.1%, P=1.00). No significant difference was observed when comparing the weight loss outcomes of injectables (GLP-1 receptor agonists) to oral AOMs. The proportion of patients reporting side effects was similar for both groups, regardless of the type of AOM. CONCLUSION: Patients with CeD taking AOMs had similar weight loss outcomes to patients without CeD. Hence, AOMs can be a safe and effective therapy for weight management in patients with CeD.

Implementation and Evaluation of a Curriculum for Ergonomics Training During GI Fellowship.

BACKGROUND AND AIMS: Training in ergonomics is either fragmented or lacking in most GI programs. There are limited real-world data on fellows' perceptions and change in practice after the delivery of a curriculum for ergonomics. We aim to implement a curriculum for endoscopy for our GI fellows and evaluate their response to the same. METHODS: We devised and implemented a curriculum with three components, delivered over 6 months for all GI fellows in an academic hospital center. These were one, a comprehensive, hour-long didactics session conducted by an experienced faculty member; two, an interactive session with a physical therapist; and three, provision of free resistance bands and compression stockings to fellows. We conducted a pre- and post-curriculum test. Data are presented as proportions and medians with interquartile range. RESULTS: We surveyed 23 fellows. At baseline, 13.6% (3) had sustained ERI during their training. Only 63.6% (14) of trainees reported confidence in being able to recognize signs and symptoms of ERI. Their median self-reported understanding of ergonomics was 3 on a Likert scale of 1-5, corresponding with "average understanding." The majority of trainees had never reviewed any material on ergonomics prior to this curriculum. In the post-test evaluation, the median self-reported understanding of ergonomics improved to 4, corresponding with "above average understanding." All fellows requested a repeat of the curriculum, either semi-annually or annually. CONCLUSION: Our data show a positive perception of trainees of a practical, reproducible, and low-cost curriculum for endoscopy incorporated during GI fellowship.

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis.

Obesity is strongly associated with nonalcoholic fatty liver disease as well as advanced forms of the disease such as nonalcoholic steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. While lifestyle and diet modifications have been the cornerstone of treatment for NASH thus far, they are only effective for less than half of the patients. New endoscopic bariatric therapies (EBTs) have already proved to be safe and effective for the treatment of obesity and type 2 diabetes mellitus, and may provide an intermediate, less invasive, cost-effective option for patients with NASH. In this review, we aim to describe the data and evidence as well as outline future areas of development for endobariatric therapies for the treatment of NASH. In conclusion, EBTs present an effective and safe therapeutic modality for use in the growing pandemic of obesity-related liver disease and should be investigated further with large-scale trials in this patient population.

Association of Hypomagnesemia and Liver Injury, Role of Gut-Barrier Dysfunction and Inflammation: Efficacy of Abstinence, and 2-Week Medical Management in Alcohol Use Disorder Patients.

(1) We investigated the involvement of serum magnesium level in early alcoholic liver disease (ALD), gut barrier dysfunction, and inflammation in alcohol use disorder (AUD) patients; and lastly, the efficacy of 2-week abstinence and medical management to alleviate hypomagnesemia. (2) Forty-eight heavy drinking AUD patients (34 males (M)/14 females (F)) participated in this study. Patients were grouped by serum alanine aminotransferase (ALT) level (a marker of liver injury) as group 1 (Group 1 (Gr.1); ALT ≤ 40 U/L, 7M/8F, without any indication of early-stage ALD) and group 2 (Group 2 (Gr.2); ALT > 40 U/L, 27M/6F or early-stage ALD). These patients were sub-divided within each group into patients with normal magnesium (0.85 and more mmol/L) and deficient magnesium (less than 0.85 mmol/L) levels. All participants were assessed at baseline (BL) and received standard medical management for 2 weeks with reassessment at the treatment end (2w). (3) Female participants of this study showed a significantly lower baseline level of magnesium than their male counterparts. Gr.2 patients showed a greater propensity in the necrotic type of liver cell death, who reported higher chronic and recent heavy drinking. Magnesium level improved to the normal range in Gr.2 post-treatment, especially in the hypomagnesemia sub-group (0.77 ± 0.06 mmol/L (BL) vs. 0.85 ± 0.05 mmol/L (2w), p = 0.02). In Gr.2, both apoptotic (K18M30) and necrotic (K18M65) responses were significantly and independently associated with inflammasome activity comprising of LBP (Lipopolysaccharide binding-protein) and TNFα (Tumor necrosis factor -α), along with serum magnesium. (4) In AUD patients with liver injury, 2-week medical management seems to improve magnesium to a normal level. This group exhibited inflammatory activity (LBP and TNFα) contributing to clinically significant hypomagnesemia. In this group, the level of magnesium, along with the unique inflammatory activity, seems to significantly predict apoptotic and necrotic types of hepatocyte death.

P027 Brain Fog in Patients With Inflammatory Bowel Disease, and Association With Use of Probiotics.

BACKGROUND: Brain fog has been minimally studied in patients with inflammatory bowel disease (IBD). IBD patients frequently consume probiotics, whether sanctioned by a physician or not. However, probiotic consumption in itself has been shown to increase the incidence of brain fog. We aimed to study the association between brain fog in IBD patients with or without probiotic use. METHODS: We conducted a cross-sectional study among patients visiting a busy IBD clinic. Patients aged >18 with a biopsy-proven diagnosis of inflammatory bowel disease, without pre-existing psychiatric illness or current use of opioid medications were included. They were divided into 2 groups: those using probiotics and those who did not. Patients were given a questionnaire that included details about symptoms of brain fog. Groups were analyzed by chi-square test for differences in baseline demographics, and Mann Whitney U test to compare outcomes between groups. A p-value < 0.05 was considered statistically significant. RESULTS: Of the 66 patients included (mean age 44±2 years), 35 (53%) were female and 59 (89.4%) were Caucasian. Among these patients, 31.8% (n = 21) took probiotics as dietary supplements with the majority (67%, n = 14) taking probiotics for over a year. Overall, there was a trend for an association between probiotic use and brain fog in all patients (p = 0.080) but no statistical significance was attained. However, brain fog was significantly associated with probiotic use among Caucasian patients (p = 0.044). Furthermore, there was a statistically significant association between brain fog and male patients using probiotics (p = 0.004). Duration of probiotic use was also associated with brain fog (p = 0.038). CONCLUSION: Consumption of probiotics was independently associated with brain fog in men, as well as Caucasian patients with IBD respectively. Given the high prevalence of probiotic use in IBD patients, prospective studies are warranted to examine the causal relationship between probiotics and IBD-associated brain fog to guide prescription of probiotic supplements for IBD.

Lower Serum Magnesium Concentrations are associated With Specific Heavy Drinking Markers, Pro-Inflammatory Response and Early-Stage Alcohol-associated Liver Injury§.

AIM: Chronic heavy alcohol intake frequently causes liver inflammation/injury, and altered mineral metabolism may be involved in this liver pathology. In this study, we evaluated the association of heavy drinking, changes in serum magnesium levels and biochemical evidence of liver injury in alcohol-use-disorder (AUD) patients who had no clinical signs or symptoms of liver injury. We also aimed to identify any sex-based differences in patients with mild or no biochemical evidence of liver injury induced by heavy drinking. METHODS: 114 heavy drinking alcohol-dependent (AD) female and male patients aged 21-65 years without clinical manifestations of liver injury, who were admitted to an alcohol treatment program, were grouped by alanine aminotransaminase (ALT) levels: ≤ 40 IU/L, as no liver injury (GR.1), and ALT>40 IU/L as mild liver injury (GR.2). Patients were actively drinking until the day of admission. Comprehensive metabolic biochemistry results, fatty acid panel, serum magnesium and drinking history data were collected at admission; and study-specific measures were evaluated. RESULTS: In all AD patients, lower magnesium was significantly associated with the heavy drinking marker and heavy drinking days past 90 days (HDD90). A lower serum magnesium concentration was observed in AD patients with mild liver injury. Females of both groups had mean levels of magnesium in the deficient range. A clinically significant drop in magnesium levels was observed only in the GR.2 (mild liver injury) male AD patients. Females showed a significant association between low magnesium levels and the ω6:ω3 polyunsaturated fatty acids (PUFAs) ratio. CONCLUSIONS: Specific heavy drinking markers showed an association with lower magnesium levels. Low serum magnesium levels are common in subjects with AUD and appear to be associated with the onset of liver injury.

Gut motility and hormone changes after bariatric procedures.

PURPOSE OF REVIEW: Metabolic and bariatric surgery (MBS) and endoscopic bariatric therapies (EBT) are being increasingly utilized for the management of obesity. They work through multiple mechanisms, including restriction, malabsorption, and changes in the gastrointestinal hormonal and motility. RECENT FINDINGS: Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) cause decrease in leptin, increase in GLP-1 and PYY, and variable changes in ghrelin (generally thought to decrease). RYGB and LSG lead to rapid gastric emptying, increase in small bowel motility, and possible decrease in colonic motility. Endoscopic sleeve gastroplasty (ESG) causes decrease in leptin and increase in GLP-1, ghrelin, and PYY; and delayed gastric motility. SUMMARY: Understanding mechanisms of action for MBS and EBT is critical for optimal care of patients and will help in further refinement of these interventions.

Assessing ChatGPT vs. Standard Medical Resources for Endoscopic Sleeve Gastroplasty Education: A Medical Professional Evaluation Study.

BACKGROUND AND AIMS: The Chat Generative Pre-Trained Transformer (ChatGPT) represents a significant advancement in artificial intelligence (AI) chatbot technology. While ChatGPT offers promising capabilities, concerns remain about its reliability and accuracy. This study aims to evaluate ChatGPT's responses to patients' frequently asked questions about Endoscopic Sleeve Gastroplasty (ESG). METHODS: Expert Gastroenterologists and Bariatric Surgeons, with experience in ESG, were invited to evaluate ChatGPT-generated answers to eight ESG-related questions, and answers sourced from hospital websites. The evaluation criteria included ease of understanding, scientific accuracy, and overall answer satisfaction. They were also tasked with discerning whether each response was AI generated or not. RESULTS: Twelve medical professionals with expertise in ESG participated, 83.3% of whom had experience performing the procedure independently. The entire cohort possessed substantial knowledge about ESG. ChatGPT's utility among participants, rated on a scale of one to five, averaged 2.75. The raters demonstrated a 54% accuracy rate in distinguishing AI-generated responses, with a sensitivity of 39% and specificity of 60%, resulting in an average of 17.6 correct identifications out of a possible 31. Overall, there were no significant differences between AI-generated and non-AI responses in terms of scientific accuracy, understandability, and satisfaction, with one notable exception. For the question defining ESG, the AI-generated definition scored higher in scientific accuracy (4.33 vs. 3.61, p = 0.007) and satisfaction (4.33 vs. 3.58, p = 0.009) compared to the non-AI versions. CONCLUSIONS: This study underscores ChatGPT's efficacy in providing medical information on ESG, demonstrating its comparability to traditional sources in scientific accuracy.

A comprehensive analysis of health care Inequities in randomized clinical trials following bariatric surgeries.

BACKGROUND: Obesity is a global epidemic, leading to an increasing focus on interventions like bariatric surgeries. Despite this, there's a noticeable gap in understanding the demographic distribution of patients in clinical trials for bariatric surgery. METHODS: We conducted a comprehensive analysis of 117 registered randomized clinical trials related to bariatric surgery on ClinicalTrials.gov. We extracted demographic information, including age, sex, race, and ethnicity, and performed descriptive statistical analyses. RESULTS: The analysis covered 8,418 participants. The mean age was 43.8 years, with a substantial majority (93.8 â€‹%) falling within the 18-65 age group. Females comprised 74.9 â€‹% of participants, surpassing real-world estimates. Racially, 65.3 â€‹% of participants were White, while African Americans represented 18.5 â€‹%, Asians 1.2 â€‹%, Native Hawaiians 0.2 â€‹%, and American Indians 0.1 â€‹%, indicating an underrepresentation of diverse racial groups, notably lower compared to real-world demographic data. In terms of ethnicity, only 17.6 â€‹% were Hispanic. CONCLUSIONS: This study reveals significant demographic disparities in patients undergoing bariatric surgeries in clinical trials. This suggests a lack of generalizability, emphasizing the need for inclusive recruitment strategies to enhance health equity.

Applicability of individualized metabolic surgery score for prediction of diabetes remission after endoscopic sleeve gastroplasty.

Background: Endoscopic sleeve gastroplasty (ESG) is a safe and effective obesity treatment. The individualized metabolic score (IMS) is a validated score that uses preoperative variables predicting T2D remission (DR) in bariatric surgery. Objectives: We evaluated the applicability of using the IMS score to predict DR in patients after ESG. Design/Methods: We performed a retrospective review of patients with obesity and T2D who underwent ESG. We calculated DR, IMS score, and severity, and divided patients based on IMS category. Results: The cohort comprised 20 patients: 25% (5) mild, 55% (11) moderate, and 20% (4) severe IMS stages. DR was achieved in 60%, 45.5%, and 0% of patients with mild, moderate, and severe IMS scores (p = 0.08), respectively. IMS score was significantly associated with DR (p = 0.03), with the area under the curve of the receiver operating characteristic for predicting DR 0.85. Conclusion: These pilot data demonstrate that the IMS score appears to be useful in predicting DR after ESG.

Use of individualized metabolic surgery score in endoscopic sleeve gastroplasty Why was the study done? Endoscopic sleeve gastroplasty (ESG) is effective and safe as a treatment for obesity and has also shown improvement in diabetes in previous studies. However, there is no data showing the rates of diabetes remission after this procedure and no measures to predict this outcome. This study uses the individualized metabolic score (IMS) to predict diabetes remission after ESG. What did the researchers do? They analyzed a sample of patients who had undergone ESG, and evaluated the change in their diabetes parameters at 1 year compared to baseline, and then correlated this with their calculated baseline IMS score. What did the researchers find? Patients with a higher IMS score, representing more severe disease, were less likely to have an improvement in their diabetes after ESG. What do the findings mean? ESG can be an effective treatment option for patients with obesity and early-stage diabetes.

Weight loss outcomes with semaglutide based on diabetes severity using the individualized metabolic surgery score.

Background: Semaglutide demonstrated inferior weight loss responses in patients with type 2 diabetes (T2D) compared to patients with obesity without T2D. The individualized metabolic surgery (IMS) score was validated to predict T2D remission after bariatric surgery. The parameters of the IMS are HbA1c (<7%), insulin use, T2D medications and T2D duration. We aim to assess weight loss outcomes of semaglutide based on IMS score in patients with obesity and T2D. Methods: This is a retrospective multicentered cohort study of patients with T2D and BMI≥ 27 kg/m2 taking ≥1 mg of semaglutide recruited from January 2020 to December 2022. We excluded patients with a history of bariatric surgery or taking other anti-obesity medications. IMS was calculated at baseline and patients weight change was recorded at baseline, 3, 6, 9 and 12 months. IMS was classified as mild (0-24.9 points), moderate (25-94.9 points), and severe (95-180 points). Analysis was performed based on IMS score quartiles and combination of Mild-Moderate vs Severe categories. We performed mixed linear regression models including age, sex, and baseline weight to assess associations between IMS categories with total body weight loss percentage (TBWL%). Findings: We included 297 patients (42% female, mean age 62 ± 12 years) in the analysis. At 12 months, there was a stepwise decrease in weight loss outcomes when comparing patients by IMS quartiles (LS mean TBWL%± SE): 8.8 ± 0.8% vs 6.9 ± 0.8% vs 5.7 ± 0.9% vs 5.0 ± 0.8%. In the mixed linear model, patients in the mild-moderate category achieved significantly superior weight loss outcomes (LS mean TBWL± SE: -8.3 ± 0.7%) than patients in the severe category (-5.5 ± 0.6%; difference: -2.9, 95% CI: -5.2 to -0.5, p = 0.006) at 12 months. There was no significant difference in glycemic improvement regardless of IMS severity at baseline. Interpretation: In our cohort, lower IMS severity was associated with more weight loss in patients with obesity and T2D. Further studies are needed to understand T2D severity and its effect on semaglutide outcomes. Funding: Beyond payment to the research staff by Mayo Clinic, this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Performance of Endoscopic Sleeve Gastroplasty by Obesity Class in the United States Clinical Setting.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.

Outcomes of concomitant antiobesity medication use with endoscopic sleeve gastroplasty in clinical US settings.

Background: To evaluate the weight loss outcomes of the large US cohort of patients undergoing endoscopic sleeve gastroplasty (ESG) with or without concomitant anti-obesity (AOM) use. Methods: We performed a retrospective analysis of adult patients who underwent ESG from seven different sites, from January 1, 2020 to November 30, 2022. Percent total body weight loss (%TBWL) and %excess weight loss (%EWL) were calculated based on baseline weight at the procedure. Medication use was considered if the subject received a prescribed AOM during the study period. SPSS (version 29.0) was used for statistical analyses. Results: A total of 1506 patients were included (1359 (90.2 %) no AOM use and 147 (9.8 %) AOM use). Patients who were on an active AOM at the time of the procedure had a significantly lower TBWL% as compared to patients not on AOMs at 6 months. At the 24-month visit, patients who were prescribed AOMs after the 12-month visit had a significantly higher TBWL% and EWL% as compared to patients who were on active AOM at the time of the procedure. There was no significant difference between classes of medications at any time point, however, patients on a GLP-1RA had a trend towards improved weight loss at 18 and 24 months. Conclusion: In this large, real-world cohort of patients from the United States, data signal that with the use of pharmacotherapy at the appropriate time, patients can achieve optimal results.