Faculty Bibliography

BACKGROUND:Given the cardiovascular, renal, and survival benefits of GLP-1 receptor agonists for diabetes, these agents could be effective among kidney transplant recipients. However, kidney transplant recipients are distinct from GLP-1 receptor agonist trial participants, with longer diabetes duration and severity, greater end-organ damage, increased cardiovascular risk, and multimorbidity. We examined GLP-1 receptor agonist real-world effectiveness and safety in kidney transplant recipients with diabetes. METHODS:This USA-based retrospective cohort study included kidney transplant recipients with type 2 diabetes at transplantation and Medicare as their primary insurance from a national registry linked with Medicare claims. Post-transplantation GLP-1 receptor agonist use was identified through Medicare claims. Death-censored graft loss was estimated using the Fine-Gray sub-distribution hazard model and extended Cox models were used for mortality and safety endpoints. Models incorporated inverse probability of treatment weights. To further test whether bias could affect the main results, a cohort was created in which each GLP-1 receptor agonist user was matched with a kidney transplant recipient who had not started a GLP-1 receptor agonist, was alive with a functioning graft, and had accrued the same amount of post-transplant survival time. FINDINGS/RESULTS:Between Jan 1, 2013 and Dec 31, 2020, we identified 44 536 first time kidney transplant recipients with Medicare as primary payer in the 6 months before and at transplantation. 24 192 patients were excluded as they did not have type 2 diabetes. 2328 patients were ineligible (1916 had missing values and 412 used GLP-1 receptor agonists before transplantation). The primary cohort thus consisted of 18 016 kidney transplant recipients with diabetes. Of these patients, 1969 (10·9%) had at least one GLP-1 receptor agonist prescription filled post-transplant. Compared with patients who had not received a GLP-1 receptor agonist, GLP-1 receptor agonist users were younger (median age at transplant 57 years [IQR 49-64] vs 60 years [51-66], p<0·0001) and more likely to be female (786 [39·9%] vs 5645 [35·2%], p<0·0001). Among GLP-1 receptor agonist users, 552 [28·0%] were non-Hispanic White, 703 [35·7%] were non-Hispanic Black, and 568 [28·8%] were Hispanic. The 5-year unadjusted cumulative incidence of death-censored graft loss from a cohort matched on survival time before GLP-1 receptor agonist initiation was 6·0% for GLP-1 receptor agonist users and 10·7% for non-users (Gray's test p=0·004). The 5-year unadjusted cumulative incidence for mortality from a cohort matched on survival time before GLP-1 receptor agonist initiation was 17·0% for GLP-1 receptor agonist users and 25·8% for non-users (log-rank p=0·0006). The 5-year unadjusted cumulative incidence for mortality was 13·5% for GLP-1 receptor agonist users and 19·9% for non-users (log-rank p<0·0001). GLP-1 receptor agonist use was associated with a 49% lower incidence of death-censored graft loss (adjusted subhazard ratio [aSHR] 0·51, 95% CI 0·36-0·71; p=0·0001) and 31% lower mortality (adjusted hazard ratio [aHR] 0·69, 95% CI 0·55-0·86; p=0·001). Inferences were robust when matched on survival time (death-censored graft loss aSHR 0·53, 95% CI 0·37-0·75; p=0·0005; mortality aHR 0·70, 95% CI 0·55-0·88; p=0·003). Safety endpoints were rare and not associated with GLP-1 receptor agonists, with the exception of diabetic retinopathy (aHR 1·49, 1·11-2·00; p=0·008). INTERPRETATION/CONCLUSIONS:GLP-1 receptor agonists were associated with better graft and patient survival. Clinical trials are needed to confirm these findings. FUNDING/BACKGROUND:National Institutes of Health.

BACKGROUND:Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) remains the gold standard for treating obesity. Most people regain weight from postsurgery nadir. OBJECTIVES/OBJECTIVE:Liraglutide 3.0 mg is approved for weight management. This study will examine the effects on liraglutide 3.0 mg on weight regain post-RYGB. SETTING/METHODS:University Hospital, United States. METHODS:A 56-week, double-blind, placebo-controlled study was conducted in 132 subjects, who achieved ≥25% total body weight loss (TBWL) status-post-RYGB and regained ≥10% TBWL after reaching nadir weight (NW). Subjects 18-120 months post-RYGB were randomized to receive liraglutide 3.0 mg/d (n = 89) or placebo (n = 43) with lifestyle counseling regularly for 56 weeks. The co-primary endpoints were the proportion of subjects losing at least 5%, 10%, and 15% TBWL and achieving weight lower than their NW. RESULTS:53.4% of the placebo group and 65% of the liraglutide group completed the trial due to Severe acute respiratory syndrome coronavirus 2 pandemic. The change in %TBWL from baseline to 56-weeks was -8.8 (8.5, -29.2 to 9.7) and 1.1 (3.5, -7.9 to 5.99) in the liraglutide and placebo groups, respectively. 76% and 17% of subjects achieved ≥5% TBWL at 56 weeks in the liraglutide and placebo groups, respectively; 51% and 26.0% of the liraglutide group achieved ≥10% and ≥15% TBWL, respectively. None of the placebo group lost ≥10% TBWL. Twenty-one percent of subjects receiving liraglutide surpassed postoperative NW. No subjects on placebo met this goal. Nonserious adverse events occurred in 41.6% of subjects on liraglutide. Serious adverse events (SAE) occurred less often on liraglutide. CONCLUSIONS:Liraglutide was significantly more effective than placebo in treating weight regain that occurs post-RYGB without increased SAE.

PURPOSE/OBJECTIVE:We developed a comprehensive sleeve gastrectomy (SG) weight loss study cohort and biorepository to uncover mechanisms, biomarkers and predictive factors of weight loss, weight maintenance and amelioration of obesity-related comorbidities. For this purpose, we collected psychosocial, anthropometric, clinical data and a variety of samples pre-surgery, intraoperatively and 1.5, 3, 12 and 24 months post-surgery. For longer-term assessment, the collection of psychosocial and anthropometric data was extended to 10 years. Here, we present in-depth characterisation of the cohort and detailed overview of study procedures as a foundation for future analyses. PARTICIPANTS/METHODS:We consented 647 participants between June 2017 and March 2020 from two bariatric surgery clinics in New York City-one major urban hospital and one private hospital. Of 355 participants who provided baseline data, 300 underwent SG. Of these, 79% are females with an average age of 38 years, 68% are Hispanic, 20% are non-Hispanic Black and 11% are non-Hispanic White. FINDINGS TO DATE/RESULTS:We collected intraoperative adipose and stomach tissues from 282 patients and biosamples (blood, urine, saliva, stool) from 245 patients at 1.5 months, 238 at 3 month, 218 at 12 months and 180 at 24 months post-surgery. We are currently collecting anthropometric and psychosocial data annually until 10 years post-surgery. Data analysis is currently underway. FUTURE PLANS/UNASSIGNED:Our future research will explore the variability in weight loss outcomes observed in our cohort, particularly among Black and Hispanic patients in comparison to their White counterparts. We will identify social determinants of health, metabolic factors and other variables that may predict weight loss success, weight maintenance and remission of obesity-related comorbidities. Additionally, we plan to leverage our biorepository for collaborative research studies. We will complete long-term follow-up data by December 2031. We plan to apply for funding to expand biosample collection through year 10 to provide insights into the mechanisms of long-term weight maintenance.

OBJECTIVES/OBJECTIVE:Obesogenic medications are a putative contributor to the obesity epidemic. While 20% of adults take ≥1 obesogenic medication, the proportion in the end-stage kidney disease (ESKD) population-a group enriched for cardiometabolic complications-is unknown. Obesogenic medications may contribute to obesity and hamper weight loss efforts to achieve transplant listing. METHODS:Using 2017-2020 USRDS and Medicare claims, patients were identified as taking obesogenic medications if prescribed anticonvulsants, antidepressants, antidiabetics, anti-inflammatories, antipsychotics, and/or antihypertensives known to cause weight gain for ≥30 days in their first hemodialysis year. Ordinal logistic and Cox regression with inverse probability of treatment weighting were used to quantify obesogenic medications' association with body mass index (BMI) and listing, respectively. RESULTS:Among 271 401 hemodialysis initiates, 63.5% took ≥1 obesogenic medication. For those in underweight, normal weight, overweight, and class I, II, and III categories, 54.3%, 58.4%, 63.1%, 66.5%, 68.6%, and 68.8% took ≥1, respectively. Number of obesogenic medications was associated with increased BMI; use of one was associated with 13% increased odds of higher BMI (aOR [adjusted odds ratio] 1.14; 95%CI: 1.13-1.16; p < 0.001), use of three was associated with a 55% increase (aOR 1.55; 95%CI: 1.53-1.57; p < 0.001). Any use was associated with 6% lower odds of transplant listing (aHR [adjusted hazard ratio] 0.94; 95%CI: 0.92-0.96; p < 0.001). Within each BMI category, obesogenic medication use was associated with lower listing likelihood. CONCLUSIONS:Obesogenic medication use is common in ESKD patients-particularly those with obesity-and is associated with lower listing likelihood. Whenever possible, non-obesogenic alternatives should be chosen for ESKD patients attempting weight loss to achieve transplant listing.

PURPOSE/OBJECTIVE:With the continued increase in bariatric procedures being performed in the USA, a growing percentage are revisions for weight regain after sleeve gastrectomy (SG) and gastric banding (LAGB). Standard practice in the USA involves conversion to Roux-en-Y gastric bypass (RYGB). Internationally, one anastomosis gastric bypass (OAGB) has become a popular and effective alternative. Without the jejuno-jejunal anastomosis, OAGB has reduced potential related long-term complications. The purpose of this study is to compare the short-term safety of revision to OAGB versus RYGB. MATERIALS AND METHODS/METHODS:Patients who underwent conversion to OAGB from LAGB or SG for weight regain from January 2019 to October 2021 were compared to BMI, sex, and age-matched patients who underwent conversion to RYGB. RESULTS:In our study, 82 patients were included, 41 in each cohort (41 OAGB vs. 41 RYGB). The majority in both groups underwent conversion from SG (71% vs. 78%). Operative time, estimated blood loss, and length of stay were comparable. There was no difference in 30-day complications (9.8% vs. 12.2%, p = .99) or reoperation (4.9% vs. 4.9%, p = .99). Mean weight loss at 1 month was also comparable (7.91 lbs vs 6.36 lbs). CONCLUSIONS:Patients undergoing conversion to OAGB for weight regain had similar operative times, post-operative complication rates, and 1-month weight loss compared to those who underwent RYGB. While more research is needed, this early data suggests that OAGB and RYGB provide comparable outcomes when used as conversion procedures for to failed weight loss. Therefore, OAGB may present a safe alternative to RYGB.

BACKGROUND:Laparoscopic adjustable gastric band (LAGB) management continues to be an important part of many metabolic and bariatric surgery practices. OBJECTIVES/OBJECTIVE:To replace the existing American Society for Metabolic and Bariatric Surgery (ASMBS) LAGB adjustment credentialing guidelines for physician extenders with consensus statements that reflect the current state of LAGB management. SETTING/METHODS:ASMBS Integrated Health Clinical Issues Committee. METHODS:A modified Delphi process using a 2-stage consensus approach was conducted on LAGB management. Thirty-four consensus statements were developed following a literature search on a wide range of LAGB topics. A 5-point Likert scale was implemented to measure consensus agreement with a Delphi panel of 39 expert participants who were invited and agreed to participate in 2 rounds of Delphi questionnaires. Consensus was set a priori at 75% agreement, defined as the proportion of participants responding with agreement (i.e., 4 or 5) or disagreement (i.e., 1 or 2) on the Likert scale. RESULTS:Consensus was reached on 74% (25 of 34) of the LAGB management statements. In Delphi round 1, 95% (37 of 39) of the participants responded to 34 consensus statements; 21 of the statements (62%) met the 75% criteria for consensus. Thirty-one participants (80%) responded in round 2, shifting the agreement on 4 more statements to the 75% threshold. CONCLUSION/CONCLUSIONS:The ASMBS consensus statement on LAGB management is intended to guide practice with current evidence-based knowledge and professional experience. The ASMBS is not a credentialing body and does not seek to guide credentialing with this document.

BACKGROUND:Bariatric procedures are safe and effective treatments for obesity, inducing rapid and sustained loss of excess body weight. Laparoscopic adjustable gastric banding (LAGB) is unique among bariatric interventions in that it is a reversible procedure in which normal gastrointestinal anatomy is maintained. Knowledge regarding how LAGB effects change at the metabolite level is limited. OBJECTIVES/OBJECTIVE:To delineate the impact of LAGB on fasting and postprandial metabolite responses using targeted metabolomics. SETTING/METHODS:Individuals undergoing LAGB at NYU Langone Medical Center were recruited for a prospective cohort study. METHODS:We prospectively analyzed serum samples from 18 subjects at baseline and 2 months after LAGB under fasting conditions and after a 1-hour mixed meal challenge. Plasma samples were analyzed on a reverse-phase liquid chromatography time-of-flight mass spectrometry metabolomics platform. The main outcome measure was their serum metabolite profile. RESULTS:We quantitatively detected over 4,000 metabolites and lipids. Metabolite levels were altered in response to surgical and prandial stimuli, and metabolites within the same biochemical class tended to behave similarly in response to either stimulus. Plasma levels of lipid species and ketone bodies were statistically decreased after surgery whereas amino acid levels were affected more by prandial status than surgical condition. CONCLUSIONS:Changes in lipid species and ketone bodies postoperatively suggest improvements in the rate and efficiency of fatty acid oxidation and glucose handling after LAGB. Further investigation is necessary to understand how these findings relate to surgical response, including long term weight maintenance, and obesity-related comorbidities such as dysglycemia and cardiovascular disease.

BACKGROUND:Laparoscopic adjustable gastric banding (LAGB) continues to be a valid surgical treatment option to address severe obesity. However, outcomes are varied and can be difficult to predict. Early prediction of suboptimal weight loss following LAGB may enable adjustments to postoperative care and consequently improve surgical outcomes. Therefore, our aim is to investigate the prognostic utility of using early weight loss following LAGB to predict long-term weight outcomes. METHODS:Clinical data from patients undergoing LAGB between 2001 and 2007 at a single institution were retrospectively collected and analysed. The data was used to inform a model for predicting long-term weight loss after LAGB surgery. Percent total weight loss (%TWL) greater than 20% 1 year after surgery was considered a measurement of success since it has been associated with the improvement of comorbidities and increased patient satisfaction. RESULTS:The average %TWL 1 year after LAGB surgery was 23.73% (n = 1524, SD = 8.68%). Weight loss of less than 10% in 1 year was a negative predictor of weight loss >20% in 8-12 years (OR = 0.449; p = 0.002; 95% CI = 0.272-0.742). Moreover, weight loss >20% in 1 year was a strong predictor of weight loss >20% in 8-12 years (OR = 5.33; p < 0.001; 95% CI = 3.17-8.97). CONCLUSION:Total body weight reduction of less than 10% 1 year after LAGB surgery suggests a lesser weight loss at 8-12 years. For these patients, targeted interventions would be appropriate to increase the chances of long-term success.

BACKGROUND:Patients infected with novel COVID-19 virus have a spectrum of illnesses ranging from asymptomatic to death. Data have shown that age, sex, and obesity are strongly correlated with poor outcomes in COVID-19-positive patients. Bariatric surgery is the only treatment that provides significant, sustained weight loss in the severely obese. OBJECTIVES/OBJECTIVE:Examine if prior bariatric surgery correlates with increased risk of hospitalization and outcome severity after COVID-19 infection. SETTING/METHODS:test or Fisher's exact test. Additionally, overall length of stay and duration of time in intensive care unit (ICU) were compared using Wilcoxon rank sum test. Conditional logistic regression analyses were done to determine both unadjusted (UOR) and adjusted odds ratios (AOR). RESULTS:(SD = 6.5, P < .0001). There was also less burden of diabetes in the bariatric group (32%) compared with the control group (48%) (P = .0019). Patients with a history of bariatric surgery were less likely to be admitted through the emergency room (UOR = .39, P = .0001), less likely to require a ventilator during the admission (UOR=.42, P = .028), had a shorter length of stay in both the ICU (P = .033) and overall (UOR = .44, P = .0002), and were less likely to be deceased at discharge compared with the control group (OR = .42, P = .028). CONCLUSION/CONCLUSIONS:A history of bariatric surgery significantly decreases the risk of emergency room admission, mechanical ventilation, prolonged ICU stay, and death in patients with COVID-19. Even when adjusted for BMI and the co-morbidities associated with obesity, patients with a history of bariatric surgery still have a significant decrease in the risk of emergency room admission.

[Figure: see text].