Prediction of thirty-day morbidity and mortality after duodenal switch using an artificial neural network.

BACKGROUND: Understanding factors that increase risk of both mortality and specific measures of morbidity after duodenal switch (DS) is important in deciding to offer this weight loss operation. Artificial neural networks (ANN) are computational deep learning approaches that model complex interactions among input factors to optimally predict an outcome. Here, a comprehensive national database is examined for patient factors associated with poor outcomes, while comparing the performance of multivariate logistic regression and ANN models in predicting these outcomes. METHODS: 2907 DS patients from the 2019 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database were assessed for patient factors associated with the previously validated composite endpoint of 30-day postoperative reintervention, reoperation, readmission, or mortality using bivariate analysis. Variables associated (P ≤ 0.05) with the endpoint were imputed in a multivariate logistic regression model and a three-node ANN with 20% holdback for validation. Goodness-of-fit was assessed using area under receiver operating curves (AUROC). RESULTS: There were 229 DS patients with the composite endpoint (7.9%), and 12 mortalities (0.4%). Associated patient factors on bivariate analysis included advanced age, non-white race, cardiac history, hypertension requiring 3 + medications (HTN), previous foregut/obesity surgery, obstructive sleep apnea (OSA), and higher creatinine (P ≤ 0.05). Upon multivariate analysis, independently associated factors were non-white race (odds ratio 1.40; P = 0.075), HTN (1.55; P = 0.038), previous foregut/bariatric surgery (1.43; P = 0.041), and OSA (1.46; P = 0.018). The nominal logistic regression multivariate analysis (n = 2330; R2 = 0.02, P < 0.001) and ANN (R2 = 0.06; n = 1863 [training set], n = 467 [validation]) models generated AUROCs of 0.619, 0.656 (training set) and 0.685 (validation set), respectively. CONCLUSION: Readily obtainable patient factors were identified that confer increased risk of the 30-day composite endpoint after DS. Moreover, use of an ANN to model these factors may optimize prediction of this outcome. This information provides useful guidance to bariatricians and surgical candidates alike.

Gastroesophageal Reflux Disease Outcomes After Vertical Sleeve Gastrectomy and Gastric Bypass.

OBJECTIVE: The objective of this study is to assess whether vertical sleeve gastrectomy (VSG) increases the incidence of gastroesophageal reflux disease (GERD), esophagitis and Barrett esophagus (BE) relative to patients undergoing Roux-en-Y gastric bypass (RYGB) in patients with and without preoperative GERD. SUMMARY OF BACKGROUND DATA: Concerns for potentiation of GERD, supported by multiple high-quality retrospective studies, have hindered greater adoption of the VSG. METHODS: From the OptumLabs Data Warehouse, VSG and RYGB patients with ≥2 years enrollment were identified and matched by follow-up time. GERD [reflux esophagitis, prescription for acid reducing medication (Rx) and/or diagnosis of BE], upper endoscopy (UE), and re-admissions were evaluated beyond 90 days. RESULTS: A total of 8362 patients undergoing VSG were matched 1:1 to patients undergoing RYGB, on the basis of post-operative follow-up interval. Age, sex, and follow-up time were similar between the 2 groups (P > 0.05). Among all patients, postoperative GERD was more frequently observed in VSG patients relative to RYGB patients (60.2% vs 55.6%, respectively; P < 0.001), whereas BE was more prevalent in RYGB patients (0.7% vs 1.1%; P = 0.007). Postoperatively, de novo esophageal reflux symptomatology was more common in VSG patients (39.3% vs 35.3%; P < 0.001), although there was no difference in development of the histologic diagnoses reflux esophagitis and BE. Furthermore, postoperative re-admission was higher in the RYGB cohort (38.9% vs 28.9%; P < 0.001). CONCLUSIONS: Compared to RYGB, VSG may not have inferior long-term GERD outcomes, while also leading to fewer re-hospitalizations. These data challenge the prevailing opinion that patients with GERD should undergo RYGB instead of VSG.

Bariatric Surgery is Associated With Decreased Progression of Nonalcoholic Fatty Liver Disease to Cirrhosis: A Retrospective Cohort Analysis.

OBJECTIVE: This study sought to compare trends in the development of cirrhosis between patients with NAFLD who underwent bariatric surgery and a well-matched group of nonsurgical controls. SUMMARY OF BACKGROUND DATA: Patients with NAFLD who undergo bariatric surgery generally have improvements in liver histology. However, the long-term effect of bariatric surgery on clinically relevant liver outcomes has not been investigated. METHODS: From a large insurance database, patients with a new NAFLD diagnosis and at least 2 years of continuous enrollment before and after diagnosis were identified. Patients with traditional contraindications to bariatric surgery were excluded. Patients who underwent bariatric surgery were identified and matched 1:2 with patients who did not undergo bariatric surgery based on age, sex, and comorbid conditions. Kaplan-Meier analysis and Cox proportional hazards modeling were used to evaluate differences in progression from NAFLD to cirrhosis. RESULTS: A total of 2942 NAFLD patients who underwent bariatric surgery were identified and matched with 5884 NAFLD patients who did not undergo surgery. Cox proportional hazards modeling found that bariatric surgery was independently associated with a decreased risk of developing cirrhosis (hazard ratio 0.31, 95% confidence interval 0.19-0.52). Male gender was associated with an increased risk of cirrhosis (hazard ratio 2.07, 95% confidence interval 1.31-3.27). CONCLUSIONS: Patients with NAFLD who undergo bariatric surgery are at a decreased risk for progression to cirrhosis compared to well-matched controls. Bariatric surgery should be considered as a treatment strategy for otherwise eligible patients with NAFLD. Future bariatric surgery guidelines should include NAFLD as a comorbid indication when determining eligibility.

Prediction of thirty-day morbidity and mortality after laparoscopic sleeve gastrectomy: data from an artificial neural network.

BACKGROUND: Multiple patient factors may convey increased risk of 30-day morbidity and mortality after laparoscopic vertical sleeve gastrectomy (LVSG). Assessing the likelihood of short-term morbidity is useful for both the bariatric surgeon and patient. Artificial neural networks (ANN) are computational algorithms that use pattern recognition to predict outcomes, providing a potentially more accurate and dynamic model relative to traditional multiple regression. Using a comprehensive national database, this study aims to use an ANN to optimize the prediction of the composite endpoint of 30-day readmission, reoperation, reintervention, or mortality, after LVSG. METHODS: A cohort of 101,721 LVSG patients was considered for analysis from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national dataset. Select patient factors were chosen a priori as simple, pertinent and easily obtainable, and their association with the 30-day endpoint was assessed. Those factors with a significant association on both bivariate and multivariate nominal logistic regression analysis were incorporated into a back-propagation ANN with three nodes each assigned a training value of 0.333, with k-fold internal validation. Logistic regression and ANN models were compared using area under receiver-operating characteristic curves (AUROC). RESULTS: Upon bivariate analysis, factors associated with 30-day complications were older age (P = 0.03), non-white race, higher initial body mass index, severe hypertension, diabetes mellitus, non-independent functional status, and previous foregut/bariatric surgery (all P < 0.001). These factors remained significant upon nominal logistic regression analysis (n = 100,791, P < 0.001, r2= 0.008, AUROC = 0.572). Upon ANN analysis, the training set (80% of patients) was more accurate than logistic regression (n = 80,633, r2= 0.011, AUROC = 0.581), and it was confirmed by the validation set (n = 20,158, r2= 0.012, AUROC = 0.585). CONCLUSIONS: This study identifies a panel of simple and easily obtainable preoperative patient factors that may portend increased morbidity after LSG. Using an ANN model, prediction of these events can be optimized relative to standard logistic regression modeling.

Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.

Importance: The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. Objective: To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. Design, Setting, and Participants: Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016. Interventions: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. Main Outcomes and Measures: The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years. Results: Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. Conclusions and Relevance: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

Bariatric Surgery: A Perspective for Primary Care.

IN BRIEF Bariatric surgery is the most efficacious treatment for obesity, type 2 diabetes, and other obesity-related comorbidities. In this article, the authors review the current indications for bariatric surgery and discuss the most commonly performed procedures. They analyze medical outcomes of bariatric procedures by reviewing key prospective trials and discuss changes in physiology after these procedures. They conclude by discussing long-term management of bariatric patients by reviewing current guidelines for nutritional support and listing common complications related to these procedures.

Bile Acids Increase Independently From Hypocaloric Restriction After Bariatric Surgery.

OBJECTIVES: To measure changes in the composition of serum bile acids (BA) and the expression of Takeda G-protein-coupled receptor 5 (TGR5) acutely after bariatric surgery or caloric restriction. SUMMARY BACKGROUND DATA: Metabolic improvement after bariatric surgery occurs before substantial weight loss. BA are important metabolic regulators acting through the farnesoid X receptor and TGR5 receptor. The acute effects of surgery on BA and the TGR5 receptor in subcutaneous white adipose tissue (WAT) are unknown. METHODS: A total of 27 obese patients with type 2 diabetes mellitus were randomized to Roux-en-Y gastric bypass (RYGB) or to hypocaloric diet (HC diet) restriction (NCT 1882036). A cohort of obese patients with and without type 2 diabetes mellitus undergoing vertical sleeve gastrectomy was also recruited (n = 12) as a comparison. RESULTS: After vertical sleeve gastrectomy, the level of BA increased [total: 1.17 ±â€Š1.56 µmol/L to 4.42 ±â€Š3.92 µmol/L (P = 0.005); conjugated BA levels increased from 0.99 ±â€Š1.42 µmol/L to 3.59 ±â€Š3.70 µmol/L (P = 0.01) and unconjugated BA levels increased from 0.18 ±â€Š0.24 µmol/L to 0.83 ±â€Š0.70 µmol/L (P = 0.009)]. With RYGB, there was a trend toward increased BA [total: 1.37 ±â€Š0.97 µmol/L to 3.26 ±â€Š3.01 µmol/L (P = 0.07); conjugated: 1.06 ±â€Š0.81 µmol/L to 2.99 ±â€Š3.02 µmol/L (P = 0.06)]. After HC diet, the level of unconjugated BA decreased [0.92 ±â€Š0.55 µmol/L to 0.32 ± 0.43 µmol/L (P = 0.05)]. The level of WAT TGR5 gene expression decreased after surgery, but not in HC diet. Protein levels did not change. CONCLUSIONS: The levels of serum BA increase after bariatric surgery independently from caloric restriction, whereas the level of WAT TGR5 protein is unaffected.

EUS-guided sutured gastropexy for transgastric ERCP (ESTER) in patients with Roux-en-Y gastric bypass: a novel, single-session, minimally invasive approach.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) is a challenging procedure. Available techniques are hampered by limited success, need for a separate delayed session for ERCP, potential complications,and/or invasiveness. This paper reports on a novel technique that involves endoscopic ultrasound(EUS)-guided access into the remnant stomach and sutured gastropexy for transgastric ERCP in a single combined session. PATIENTS AND METHODS: A total of 10 patients with RYGB underwent transgastric ERCP using the novel technique. EUS was used to puncture the excluded stomach through the gastric pouch or jejunum,the stomach was insufflated, and a direct percutaneous gastrostomy puncture followed by sutured gastropexy was performed. ERCP was performed by passing a duodenoscope through the gastrostomy. RESULTS: Technical success of EUS-assisted sutured gastropexy was achieved in nine patients (90 %),with immediate, same-session ERCP in all nine.There were no adverse events. CONCLUSIONS: EUS-assisted, fluoroscopically guided sutured gastropexy is a safe and effective method to obtain access into the excluded gastric remnant for same-session transgastric ERCP inpatients with Roux-en-Y gastric bypass anatomy.

Investigation of the DNA target design parameters for effective hybridization-induced aggregation of particles for the sequence-specific detection of DNA.

In a recent publication, we presented a label-free method for the detection of specific DNA sequences through the hybridization-induced aggregation (HIA) of a pair of oligonucleotide-adducted magnetic particles. Here we show, through the use of modified hardware, that we are able to simultaneously analyze multiple (4) samples, and detect a 26-mer ssDNA sequence at femtomolar concentrations in minutes. As such, this work represents an improvement in throughput and a 100-fold improvement in sensitivity, compared to that reported previously. Here, we also investigate the design parameters of the target sequence, in an effort to maximize the sensitivity of HIA and to use as a guide in future applications of this work. Modifications were made to the original 26-mer oligonucleotide sequence to evaluate the effects of: (1) non-complementary flanking bases, (2) target sequence length, and (3) single base mismatches on aggregation response. The aggregation response decreased as the number of the non-complementary flanking bases increased, with only a five base addition lowering the LOD by four orders of magnitude. Low sensitivity was observed with short sequences of 6 and 10 complementary bases, which were only detectable at micromolar concentrations. Target sequences with 20, 26 or 32 complementary bases provided the greatest sensitivity and were detectable at femtomolar concentrations. Additionally, HIA could effectively differentiate sequences that were fully complementary from those containing 1, 2 or 3 single base mismatches at micromolar concentrations. The robustness of the HIA system to other buffer components was explored with nine potential assay interferents that could affect hybridization (aggregation) or falsely induce aggregation. Of these, purified BSA and lysed whole blood induced a false aggregation. None of the interferents inhibited aggregation when the hybridizing target was added. Having delineated the fundamental parameters affecting HIA-target hybridization, and demonstrating that HIA had the selectivity to detect single base mismatches, this fluor-free end-point detection has the potential to become a powerful tool for microfluidic DNA detection.

Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Injectable Penile Enhancement Procedures: A Review of Agents, Risks, and Complications.

Penile dysmorphophobic disorder describes men who feel their normal penile size is inadequate. Penile fillers have been used to address penile size dissatisfaction. However, unpredictability of these procedures can yield unfavorable outcomes. Reactions to these foreign bodies are inherently uncertain, owing to an array of materials, concentrations, and biocompatibility. Management of complications also varies. As fillers are more commonly used in cosmetic procedures to augment facial features, most genitourinary surgeons are unfamiliar with these therapies. This review seeks to describe the available materials, techniques, and risk profiles of the various types of fillers used for penile augmentation.

Rates and Risk Factors for 30-Day Morbidity After One-Stage Vertical Banded Gastroplasty Conversions: A Retrospective Analysis.

Background: The vertical banded gastroplasty (VBG) is a historic restrictive bariatric operation often requiring further surgery. In this investigation utilizing the 2021 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) national dataset, we aim to better define the outcomes of VBG conversions.Methods: We queried the 2021 MBSAQIP dataset for patients who underwent a conversion from a VBG to Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Demographics, comorbidities, laboratory values, and additional patient factors were examined. Rates of key consequential outcome measures 30-day readmission, reoperation, reintervention, mortality, and a composite endpoint (at least 1 of the 4) were further calculated.Results: We identified 231 patients who underwent conversion from VBG to SG (n = 23), RYGB (n = 208), or other anatomy (n = 6), of which 93% of patients were female, and 22% of non-white race. The median age was 56 years and body-mass index (BMI) was 43 kg/m2. The most common surgical indications included weight considerations (48%), reflux (25%), anatomic causes (eg, stricture, fistula, and ulcer; 10%), and dysphagia (6.5%). Thirty-day morbidity rates included reoperation (7.8%), readmission (9.1%), reintervention (4.3%), mortality (.4%), and the composite endpoint (15%). Upon bivariate analysis, we did not identify any specific risk factor for the 30-day composite endpoint.Discussion: One-stage VBG conversions to traditional bariatric anatomy are beset with higher 30-day morbidity relative to primary procedures. Additional MBSAQIP data will be required for aggregation, to better characterize the risk factors inherent in these operations.

Prediction of 30-Day Morbidity and Mortality After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass: Use of an Artificial Neural Network.

BACKGROUND: Conversion of sleeve gastrectomy to Roux-en-Y gastric bypass is indicated primarily for unsatisfactory weight loss or gastroesophageal reflux disease (GERD). This study aimed to use a comprehensive database to define predictors of 30-day reoperation, readmission, reintervention, or mortality. An artificial neural network (ANN) was employed to optimize prediction of the composite endpoint (occurrence of 1+ morbid event). METHODS: Areview of 8895 patients who underwent conversion for weight-related or GERD-related indications was performed using the 2021 MBSAQIP national dataset. Demographics, comorbidities, laboratory values, and other factors were assessed for bivariate and subsequent multivariable associations with the composite endpoint (P ≤ .05). Factors considered in the multivariable model were imputed into a three-node ANN with 20% randomly withheld for internal validation, to optimize predictive accuracy. Models were compared using receiver operating characteristic (ROC) curve analysis. RESULTS: 39% underwent conversion for weight considerations and 61% for GERD. Rates of 30-day reoperation, readmission, reintervention, mortality, and the composite endpoint were 3.0%, 7.1%, 2.1%, .1%, and 9.1%, respectively. Of the nine factors associated with the composite endpoint on bivariate analysis, only non-white race (P < .001; odds ratio 1.4), lower body-mass index (P < .001; odds ratio .22), and therapeutic anticoagulation (P = .001; odds ratio 2.0) remained significant upon multivariable analysis. Areas under ROC curves for the multivariable regression, ANN training, and validation sets were .587, .601, and .604, respectively. DISCUSSION: Identification of risk factors for morbidity after conversion offers critical information to improve patient selection and manage postoperative expectations. ANN models, with appropriate clinical integration, may optimize prediction of morbidity.

Gastric bypass after liver transplantation.

Few data are available for assessing the outcomes of bariatric surgery for patients who have undergone orthotopic liver transplantation (OLT). The University of Minnesota bariatric surgery database and transplant registry were retrospectively reviewed to identify patients who had undergone OLT and then open Roux-en-Y gastric bypass (RYGB) surgery between 2001 and 2009. Comorbidity-appropriate laboratory values, body mass indices (BMIs), histopathology reports, and immunosuppressive regimens were collected. Seven patients were identified with a mean age of 55.4 ± 8.64 years and a mean follow-up of 59.14 ± 41.49 months from the time of RYGB. The mean time between OLT and RYGB was 26.57 ± 8.12 months. The liver disease etiologies were hepatitis C (n = 4), jejunoileal bypass surgery (n = 1), hemangioendothelioma (n = 1), and alcoholic cirrhosis (n = 1). There were 2 deaths for patients with hepatitis C 6 and 9 months after bariatric surgery due to multiple-organ dysfunction syndrome and metastatic esophageal squamous carcinoma, respectively. One patient with hepatitis C required a reversal of the RYGB because of malnutrition and an inability to tolerate oral intake. Four of the 7 patients had type 2 diabetes mellitus (T2DM), 4 had hypertension, and 6 patients had dyslipidemia. All patients were on immunosuppressive medications, but only 4 were on corticosteroids. Glycemic control was improved in all surviving patients with T2DM. The mean BMI was 34.27 ± 5.51 kg/m(2) before OLT and 44.34 ± 6.08 kg/m(2) before RYGB; it declined to 26.47 ± 5.53 kg/m(2) after RYGB. In conclusion, in this case series of patients undergoing RYGB after OLT, we observed therapeutic weight loss, improved glycemic control, and improved high-density lipoprotein levels in the presence of continued dyslipidemia. RYGB may have contributed to the death of 1 patient due to multiple-organ dysfunction syndrome.

Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.

IMPORTANCE: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. OBJECTIVE: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. DESIGN, SETTING, AND PARTICIPANTS: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. INTERVENTIONS: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. MAIN OUTCOMES AND MEASURES: Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. RESULTS: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. CONCLUSIONS AND RELEVANCE: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00641251.

Effect of beta-blocker therapy on weight loss outcomes after sleeve gastrectomy & Roux-en-Y gastric bypass.

BACKGROUND: Patients taking beta-blockers (BBs) commonly experience weight gain. There is limited research exploring how BBs impact weight loss after bariatric surgery. OBJECTIVES: We examined how BBs impact 12-month weight loss in patients undergoing sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB). SETTING: Large midwest health system. METHODS: We reviewed health records of SG and RYGB patients (2011-2022) and categorized them by BB usage (none, pre-, post-, or pre- and postoperative). Multivariable linear regression models examined the relation between BB use, percent total body weight loss (%TBWL), and percent excess body mass index lost (%EBMIL). RESULTS: A total of 889 individuals (SG, n = 485; RYGB, n = 404) had complete data. RYGB led to greater %TBWL compared to SG (31% versus 26%, P < .01) and greater %EBMIL (79% versus 64%, P < .01). BB status did not significantly affect 12-month %TBWL or %EBMIL. CONCLUSIONS: BB use may not significantly affect weight loss 12 months after bariatric surgery. This finding could enable physicians to prescribe BBs for improved blood pressure control in bariatric surgery patients with less concern of blunting weight loss. Longer term follow-up with a larger sample size would be an important next step to better characterize the relationship between BB usage and bariatric surgery.

New detection modality for label-free quantification of DNA in biological samples via superparamagnetic bead aggregation.

Combining DNA and superparamagnetic beads in a rotating magnetic field produces multiparticle aggregates that are visually striking, enabling label-free optical detection and quantification of DNA at levels in the picogram per microliter range. DNA in biological samples can be quantified directly by simple analysis of optical images of microfluidic wells placed on a magnetic stirrer without prior DNA purification. Aggregation results from DNA/bead interactions driven either by the presence of a chaotrope (a nonspecific trigger for aggregation) or by hybridization with oligonucleotides on functionalized beads (sequence-specific). This paper demonstrates quantification of DNA with sensitivity comparable to that of the best currently available fluorometric assays. The robustness and sensitivity of the method enable a wide range of applications, illustrated here by counting eukaryotic cells. Using widely available and inexpensive benchtop hardware, the approach provides a highly accessible low-tech microscale alternative to more expensive DNA detection and cell counting techniques.

Case-matched outcomes in bariatric surgery for treatment of type 2 diabetes in the morbidly obese patient.

OBJECTIVE: To compare the relative efficacy of medical management, the duodenal switch (DS), and the laparoscopic adjustable gastric band (LAGB) to the Roux-en-Y gastric bypass (RYGB) for treatment of type 2 diabetes mellitus (T2DM). BACKGROUND: The RYGB resolves T2DM in a high proportion of patients and is considered the standard operation for T2DM resolution in morbidly obese patients. However, no data exist comparing the efficacy of medical management and other bariatric operations to the RYGB for treatment of T2DM in comparable patient populations. METHODS: We performed a retrospective case-matched study of morbidly obese patients with T2DM who had undergone medical management (nonsurgical controls [NSC]; N = 29), LAGB (N = 30), or DS (N = 27) and were compared with matched T2DM patients who had undergone RYGB. Matching was performed with respect to age, sex, body mass index, and hemoglobin A1C (HbA1C). Outcomes assessed were changes in body mass index, HbA1C, and diabetes medication scores at 1 year. RESULTS: The Roux-en-Y gastric bypass produced greater weight loss, HbA1C normalization, and medication score reduction compared to both NSC and LAGB-matched cohorts. Duodenal switch produced greater reductions in HbA1C and medication score than RYGB, despite no greater weight loss at 1 year. Surgical complications were rarely life threatening. CONCLUSIONS: This study provides an important perspective about the comparative efficacy of LAGB, DS, and NSC to the RYGB for treatment of T2DM among obese patients. After 1 year of follow-up, RYGB is superior to NSC and LAGB with respect to weight loss and improvement in diabetes whereas DS is superior to RYGB in reducing HbA1C and medication score.

Biochemical and Hematologic Reference Intervals for Anesthetized, Female, Juvenile Yorkshire Swine.

Swine are widely used in biomedical research, translational research, xenotransplantation, and agriculture. For these uses, physiologic reference intervals are extremely important for assessing the health status of the swine and diagnosing disease. However, few biochemical and hematologic reference intervals that comply with guidelines from the Clinical and Laboratory Standards Institute and the American Society for Veterinary Clinical Pathology are available for swine. These guidelines state that reference intervals should be determined by using 120 subjects or more. The aim of this study was to generate hematologic and biochemical reference intervals for female, juvenile Yorkshire swine (Sus scrofa domesticus) and to compare these values with those for humans and baboons (Papio hamadryas). Blood samples were collected from the femoral artery or vein of female, juvenile Yorkshire swine, and standard hematologic and biochemical parameters were analyzed in multiple studies. Hematologic and biochemical reference intervals were calculated for arterial blood samples from Yorkshire swine (n = 121 to 124); human and baboon reference intervals were obtained from the literature. Arterial reference intervals for Yorkshire swine differed significantly from those for humans and baboons in all commonly measured parameters except platelet count, which did not differ significantly from the human value, and glucose, which was not significantly different from the baboon value. These data provide valuable information for investigators using female, juvenile Yorkshire swine for biomedical re- search, as disease models, and in xenotransplantation studies as well as useful physiologic information for veterinarians and livestock producers. Our findings highlight the need for caution when comparing data and study outcomes between species.