Post-bariatric pregnancy is associated with vitamin K1 deficiency, a case control study.

BACKGROUND: Maternal obesity is associated with adverse outcome for pregnancy and childbirths. While bariatric surgery may improve fertility and reduce the risk of certain pregnancy-related complications such as hypertension and gestational diabetes mellitus, there is a lack of evidence on the optimal nutritional monitoring and supplementation strategies in pregnancy following bariatric surgery. We aimed to assess the impact of bariatric surgery on micronutrients in post-bariatric pregnancy and possible differences between gastric bypass surgery and sleeve gastrectomy. METHODS: In this prospective case control study, we recruited 204 pregnant women (bariatric surgery n = 59 [gastric bypass surgery n = 26, sleeve gastrectomy n = 31, missing n = 2] and controls n = 145) from Akershus university hospital in Norway. Women with previous bariatric surgery were consecutively invited to study participation at referral to the clinic for morbid obesity and the controls were recruited from the routine ultrasound screening in gestational week 17-20. A clinical questionnaire was completed and blood samples were drawn at mean gestational week 20.4 (SD 4.5). RESULTS: The women with bariatric surgery had a higher pre-pregnant BMI than controls (30.8 [SD 6.0] vs. 25.2 [5.4] kg/m2, p < 0.001). There were no differences between groups regarding maternal weight gain (bariatric surgery 13.3 kg (9.6) vs. control 14.8 kg (6.5), p = 0.228) or development of gestational diabetes (n = 3 [5%] vs. n = 7 [5%], p = 1.000). Mean levels of vitamin K1 was lower after bariatric surgery compared with controls (0.29 [0.35] vs. 0.61 [0.65] ng/mL, p < 0.001). Multiadjusted regression analyses revealed an inverse relationship between bariatric surgery and vitamin K1 (B -0.26 ng/mL [95% CI -0.51, -0.04], p = 0.047) with a fivefold increased risk of vitamin K1 deficiency in post-bariatric pregnancies compared with controls (OR 5.69 [1.05, 30.77] p = 0.044). Compared with sleeve gastrectomy, having a previous gastric bypass surgery was associated with higher risk of vitamin K1 deficiency (OR 17.1 [1.31, 223.3], p = 0.030). CONCLUSION: Post-bariatric pregnancy is negatively associated with vitamin K1 with a higher risk of vitamin K1 deficiency in pregnancies after gastric bypass surgery compared with after sleeve gastrectomy. Vitamin K1 deficiency in post-bariatric pregnancy have potential risk of hypocoaguble state in mother and child and should be explored in future studies.

Oral ω-3 PUFA supplementation modulates inflammation in adipose tissue depots in morbidly obese women: A randomized trial.

OBJECTIVES: Obesity is characterized by local and systemic low-grade inflammatory responses. Adipose tissue macrophages (ATM) play decisive roles in inflammation, insulin signaling, and various metabolic dysfunctions. Diets enriched with ω-3 polyunsaturated fatty acids (PUFAs) have been shown to improve health and mitigate pathologic conditions. However, the effects of ω-3 PUFA on adipose tissue inflammation, ATM number, and phenotype are poorly defined in human obesity. The aim of this study was to examine differences in expression of metabolic-inflammatory markers in omental, mesenteric, and subcutaneous fat depots of obese women supplemented with ω-3 PUFAs for 4 wk compared with a low-calorie diet before bariatric surgery. METHODS: In a randomized controlled trial, inflammatory markers in the abdominal adipose tissue and the systemic response in obese women were studied. Patients were treated with a 2-wk low-calorie diet (LCD) or a 4-wk ω-3 PUFA-enriched diet (920 mg eicosapentaenoic acid, 760 mg docosahexaenoic acid daily) before laparoscopic bypass surgery. Omental, mesenteric, and subcutaneous adipose tissue biopsies were collected during surgery and analyzed for quantity and phenotype of ATMs, and profiled for adipokines, cytokines, and signal transduction molecules. RESULTS: The chronic inflammatory state characterized by ATM markers was mostly improved by ω-3 PUFAs in visceral adipose tissue. We observed a decreased expression of CD45, CCL2, and CD68, indicating a lower inflammatory state. In patients with type 2 diabetes, ω-3 PUFAs lowered the expression of Netrin-1. CONCLUSIONS: Compared with an LCD, a diet enriched with ω-3 PUFAs influences the inflammatory state in different adipose tissue depots, by affecting markers of adipose tissue inflammation, macrophage phenotype, and retention. However, this was not reflected in clinical parameters such as insulin resistance and inflammatory cytokines. Subcutaneous adipose tissue and visceral adipose tissue have different responses to an LCD or a ω-3 PUFA-enriched diet. The presence of diabetes modifies the expression of inflammatory markers.

Safety and feasibility of same-day discharge following minimally invasive hysterectomy in the morbidly obese patient population.

OBJECTIVES: To determine whether morbid obesity should serve as an independent factor in the decision for same day discharge following minimally invasive hysterectomy. METHODS: Retrospective review was performed of patients with BMI ≥ 40 who underwent minimally invasive hysterectomy within a single comprehensive cancer center between January 2018 - August 2020. Demographics, perioperative factors, post-operative monitoring, complications, and readmissions were compared between patients who underwent same day discharge and overnight observation using Fisher's exact tests and Wilcoxon rank-sum tests. RESULTS: 374 patients with BMI ≥ 40 were included. Eighty-three (22.2%) patients underwent same day discharge, and 291 (77.8%) patients underwent overnight observation. Factors associated with increased likelihood of same day discharge included younger age (median age 53 vs 58; p = 0.001), lower BMI (median BMI 45 vs 47; p = 0.005), and fewer medical co-morbidities (Charlson Co-Morbidity Index 2 vs 3; p < 0.001). On multivariate regression analysis, frailty (OR 2.16 [1.14-4.11], p = 0.019) and surgical completion time after 12 PM (OR 3.67 [2.16-6.24], p < 0.001) were associated with increased risk of overnight observation. Few patients admitted for routine overnight observation required medical intervention (n = 14, 4.8%); most of these patients were frail (64.3%). The overall hospital readmission rate within 30 days of discharge was 3.2% (n = 12), with no patients discharged on the day of surgery being readmitted. CONCLUSIONS: Morbid obesity alone should not serve as a contraindication to same day discharge following minimally invasive hysterectomy. Admission for observation was associated with low rates of clinically meaningful intervention, and patients who underwent same day discharge were not at increased risk of adverse outcome.

Evaluation of the outcome of a proposed more physiological bypass surgery technique in morbid obesity: Long term 3 years follows up.

Background: Obesity is a chronic condition that affects millions globally; consequently, bariatric surgery is the key to this serious issue. Bariatric procedures are rapidly expanding in number and methods to address the recognized problems. So, it would make a sense for surgeons and patients if there is a more physiological bypass surgery technique in Morbid obesity. This study aims to evaluate the outcome proposed technique. Patients and methods: The present study is a retrospective analysis on 256 participants subjected to the proposed bypass procedure from December 1999 to January 2017, the participants were followed up for an interval of 3years. Results: The findings of the present study revealed a significant Excess Weight Loss (EWL). In addition, patients experienced decreased calcium, iron, vitamin B12, Hemoglobin, zinc, and Prothrombin Concentration. However, three to six months after surgery, they experienced a significant improvement until they reached normal levels without any supplement by the end of 12,18 months, with a three-year follow-up. Conclusion: This proposed Bypass Operation aims to adequate digestions as well as selective absorption without inducing any vital deficit. Most of study's population showed no elements inadequacies, although few percentages emerged during the interval of maximal weight reduction, and it were transient and minimal. No minerals or vitamins were needed.

Serum TSH, 25(OH) D and phosphorus levels predict weight loss in individuals with diabetes/prediabetes and morbid obesity: a single-center retrospective cohort analysis.

BACKGROUND: To evaluate the association of vitamin D and thyroid-stimulating hormone (TSH) with weight loss (WL) percentage (%) in patients with diabetes/prediabetes and Class II/III obesity. METHODS: A retrospective cohort study was designed. Data were collected from a database of a referral endocrinology clinic that is prospectively and systematically generated. After exclusion of unavailable cases, the study enrolled 285 patients (51 ± 11 years old, female/male = 208/77; diabetes/prediabetes = 159/126; no/on levothyroxine replacement = 176/109; Class II/III obesity = 184/101, respectively) who maintained euthyroidism and were followed up for ≥6 months. The data were analyzed to determine the predictors of WL%. RESULTS: Compared with baseline, in the median 22 months of follow-up, the whole study group lost 5.1% of their baseline body weight. As most obesity management trials define success as 'at least 10% of WL compared to baseline', we stratified the patients based on WL% extents. The distribution was as follow: Group 1 (n = 61) lost ≥10% body weight, Group 2 (n = 162) lost < 10% body weight, while Group 3 (n = 62) gained weight by the final visit. In groups 1 and 2 (weight losers), the serum thyroid stimulatig hormone (TSH) and parathyroid hormone (PTH) levels decreased and the free thyroxine (fT4), calcium, phosphorus, and 25-hydroxyvitamin D (25(OH)D) levels increased. In Group 3 (weight gainers), these changes were not observed (except for an increase in calcium levels). Regression analysis revealed that the final visit TSH (ß = - 0.14, p < 0.05), 25(OH) D (ß = 0.15, p < 0.05), and phosphorus (ß = 0.20, p < 0.05) levels predicted WL%. However, if patients with autoimmune thyroiditis were excluded from the analysis, the decrease in TSH levels was not statistically significant. CONCLUSIONS: Serum TSH, phosphorus, and 25(OH) D levels predict WL% in euthyroid patients with diabetes/prediabetes and morbid obesity. TSH predictivity seems to be a function of thyroid autoimmunity present with increased frequency in this cohort. Greater levels of phosphorus within the reference range and a sufficient vitamin D status are associated with a greater WL%.

Obesity- and sex-related metabolism of arginine and nitric oxide in adults.

BACKGROUND: There is growing interest in the supplementation of arginine (Arg) and citrulline (Cit) in obesity due to their potential anti-obesogenic and anti-inflammatory properties. However, there is no consensus on the metabolic changes in Arg kinetics in obesity. OBJECTIVES: This exploratory cross-sectional study aimed to investigate the association between obesity, sex, and sex-by-obesity interaction on whole-body Arg kinetics in a large group of human subjects. METHODS: We studied 83 nonobese [BMI (kg/m2) <30] and 80 morbidly obese (BMI >30) middle-aged individuals (40% males) enrolled in the MEDIT (Metabolism of Disease with Isotope Tracers) trial. After body-composition measurement by DXA, we collected arterial(ized) blood samples for amino acid (AA) concentrations, markers of inflammation [high-sensitivity C-reactive protein (hs-CRP)], liver function, and glucose in a postabsorptive state. We administered a pulse of AA stable tracers and measured whole-body production (WBP) of Arg, Cit, ornithine (Orn), phenylalanine, and tyrosine, and calculated their clearance (disposal capacity) and metabolite interconversions [markers for NO and de novo Arg production, systemic Arg hydrolysis, and whole-body protein breakdown (wbPB)]. We measured plasma enrichments by LC-MS/MS and statistics by Fisher's exact test or analysis of (co)variance. Significance was set at P < 0.05. RESULTS: Obese individuals were normoglycemic and characterized by low-grade inflammation (P < 0.0001) and greater wbPB (P = 0.0298). We found lower plasma Cit concentration (P < 0.0001) in the obese group but no differences in the WBP of Arg, Cit, and Orn. Furthermore, we observed overproduction of NO (P < 0.0001) in obesity but lower de novo Arg production (P = 0.0007). The WBP of Arg was lower in females for almost all Arg-related AAs, except for plasma Cit and NO production. CONCLUSIONS: Alterations in Arg metabolism are present in morbid obesity. Further studies are needed to investigate if these changes could be related to factors such as increased Arg requirement in obesity or metabolic adaptation.

Sociodemographic and Clinical Factors Associated with Severe Obesity in Adults.

BACKGROUND: In the last decades, obesity in general, including severe obesity (BMI ≥40 kg/m2), has increased disproportionately around the world, especially in low-income and lower-middle income regions. AIMS: To analyze sociodemographic and clinical characteristics of people with severe obesity in Mexico, as well as their associated factors. METHODS: A secondary analysis was carried out from the 2018-19 National Health and Nutrition Survey. Descriptive statistics and bivariate analyses by sex were used. Logistic models were estimated to identify the main factors associated with severe obesity. RESULTS: Of the total number of people with obesity in the country (2.2 million people), 3.6% had severe obesity, with an average age of 48.2. There were statistically significant differences by sex in the variables of age group, education, socioeconomic status, health insurance, hypertension, myocardial infarction, and heart failure. Being a woman, having hypertension, and hypertension/diabetes increased the odds of severe obesity. These associations were maintained when comparing people with a BMI <40 kg/m2, with those with a BMI ≥30 kg/m2 and a BMI <40 kg/m2. CONCLUSIONS: Severe obesity must appear on the Mexican political agenda. Data must be produced that can direct decision-making around the promotion of healthy lifestyles, and obesity prevention, treatment, and follow-up, based in people-centered care and through intersectoral strategies, multidisciplinary management, and holistic approaches.

Secondary Hyperparathyroidism in Obese Patients Post Sleeve Gastrectomy.

INTRODUCTION: Bariatric surgery provides an effective option for the management of morbid obesity. Several studies have investigated the association between bariatric surgery and secondary hyperparathyroidism (SHPT). This study aims to compare the levels of blood biomarkers, specifically, calcium (Ca), vitamin D, and phosphate (PO4), and their association with parathyroid hormone (PTH) levels pre- and post-bariatric surgery. In addition, it aims to assess the prevalence of hyperparathyroidism post-bariatric surgery in a tertiary care hospital in Saudi Arabia. MATERIAL AND METHODS: A prospective cohort study was conducted at a large tertiary care hospital between May 2017 and April 2019. The study included adult obese patients who underwent laparoscopic sleeve gastrectomy (LSG). Patients were excluded if they were known to have any comorbidities, receiving vitamin supplements, and those who had undergone bariatric procedures previously. Routine blood tests, including PTH, vitamin D, Ca, and PO4, were collected at baseline, and post-surgery. RESULTS: A total of 143 patients who underwent LSG were included in the study. Hyperparathyroidism was observed in 15.4% of patients at baseline and in 36.4% of patients' post-surgery (p < 0.001). Low vitamin D levels, which were highly prevalent before surgery, decreased sustainably (66.4% pre-operative and 28% at follow-up after surgery, P=0.032). Baseline hypocalcemia was observed in 20.3% of patients compared to 8.4% post-surgery (P=0.546). Hypophosphatemia was present in 60.8% of subjects at baseline, while the percentage dropped to 21.7% post-surgery. There was a significant association between PO4 and PTH levels at baseline. Post-operatively, there was a significant correlation between PTH and both vitamin D and calcium levels. CONCLUSION: Our study showed that the higher levels of PTH post LSG can be related to vitamin D deficiency and lower calcium levels, despite patients following the provided recommendations for supplementation. This study also emphasizes the importance of routine testing for hyperparathyroidism both before and after bariatric surgery.

An Isolated Dose of Extra-Virgin Olive Oil Produces a Better Postprandial Gut Hormone Response, Lipidic, and Anti-Inflammatory Profile that Sunflower Oil: Effect of Morbid Obesity.

INTRODUCTION: This study evaluates the effects of 25 mL of three types of oils [extra-virgin olive oil (EVOO), olive oil (OO), and sunflower oil (SO)] on postprandial (3 h) satiety markers and variables related to metabolic status and inflammation in non-obese patients (n = 6) and in those with morbid obesity (n = 6), before and 1 year after Roux-en-Y gastric by-pass (RYGB). METHODS AND RESULTS: After EVOO intake, serum acylated ghrelin decreases and GLP1 increases more than with OO and SO. EVOO causes a higher increase of insulin and lower postprandial hypertriglyceridemia and free fatty acid levels than with OO and SO. EVOO decreases TNFα and IL6 expression in peripheral blood mononuclear cells, with OO inducing intermediate effects and SO inducing an increase of these proinflammatory markers. These results are observed in non-obese patients and in those with morbid obesity after RYGB. However, patients with morbid obesity before RYGB show a profound alteration of this response. CONCLUSION: EVOO produces more beneficial effects than OO, which has lower amounts of minor components, and SO, which has PUFA as its main component. RYGB produces an improvement in the metabolic response to all three types of oils in patients with morbid obesity.

The Effects of One-Anastomosis Gastric Bypass on Fatty Acids in the Serum of Patients with Morbid Obesity.

PURPOSE: Obesity is associated with alterations in serum fatty acid profiles. One-anastomosis gastric bypass is a type of bariatric surgery used in the treatment of morbid obesity. The aim of this study was to establish if, between 6 and 9 months after this procedure, the fatty acid composition in the serum of patients normalizes to values similar to the healthy, lean population. MATERIALS/METHODS: The study included 46 patients that underwent surgical treatment for obesity with one-anastomosis gastric bypass. The serum fatty acid composition was determined using gas chromatography-mass spectrometry. Principal component analysis was conducted to detect the differences between fatty acid profiles in patients pre- and post-surgery, and in 29 control nonobese subjects. RESULTS: Patients with morbid obesity were characterized by lowered levels of beneficial odd- and branched-chain fatty acids and polyunsaturated fatty acids. While the odd- and branched-chain fatty acid amounts normalized 6-9 months after bariatric treatment, the polyunsaturated fatty acid levels did not. Moreover, the total fatty acid profiles of patients pre- and post-bariatric surgery were still markedly different than those of lean, healthy controls. CONCLUSION: Following one-anastomosis gastric bypass, there are some beneficial changes in serum fatty acids in treated patients, possibly due to weight loss and dietary regimen changes. However, they may be insufficient to restore the proper levels of other fatty acids, which may need to be additionally supplemented.

The effects of core stabilization exercise program in obese people awaiting bariatric surgery: A randomized controlled study.

OBJECTIVE: The aim of this study was the effects of the core stabilization exercise program (CSEP) and physical activity counseling on functional capacity, physical fitness, physical activity, fatigue and quality of life (QoL) in obese people awaiting bariatric surgery. METHODS: Twenty-one patients were divided into two groups: an exercise group (n = 10) and a control group (n = 11). Both groups received physical activity counseling, but the exercise group also performed an 8-week CSEP. Functional capacity, physical fitness, physical activity, fatigue and QoL were assessed at baseline and after 8 weeks. RESULTS: After eight weeks, results showed significant improvements in all parameters except for body composition for the exercise group, comparing to the control group (effect size = 0.40-0.87, p < 0.05). CONCLUSIONS: Implementing an 8-week adding CSEP to physical activity counseling provided significant improvements in functional capacity, physical fitness, physical activity, fatigue and QoL compared to physical activity counseling in obese people awaiting bariatric surgery.

Optimizing Multivitamin Supplementation for Sleeve Gastrectomy Patients.

PURPOSE: Micronutrient deficiencies are frequently reported after sleeve gastrectomy (SG), and therefore lifelong daily multivitamin supplementation is highly recommended. Based on literature and the results of a previous randomized controlled trial, a specialized multivitamin supplement for SG patients was further optimized (WLS Optimum 2.0, FitForMe). The present study reports on its short-term effectiveness. MATERIALS AND METHODS: An open-label study was performed in which 76 patients were included to receive WLS Optimum 2.0 for 12 months (Opt 2.0 group). This group was compared with a group of 75 patients that had received WLS Optimum 1.0 for 12 months during a previous study (Opt 1.0 group). RESULTS: Intention-to-treat analysis (Opt 1.0, n = 69; Opt 2.0, n = 75) showed higher serum levels of vitamin B12, vitamin B6, and zinc, and a lower prevalence of deficiencies for vitamin B12 and phosphate in the Opt 2.0 group. MCV and serum folic acid levels were higher in the Opt 1.0 group. Over the 12-month study period, mean increase in serum levels of phosphate, vitamin B6, and zinc was higher in the Opt 2.0 group, and MCV and serum vitamin D levels increased more in the Opt 1.0 group. CONCLUSION: The present study showed that the use of a specialized multivitamin supplement for SG patients is effective at preventing deficiencies for most vitamins and minerals, specifically in compliant patients. However, a strict follow-up regime remains necessary to monitor nutritional status and to improve patient compliance.

Clinical factors correlated with vitamin D deficiency in patients with obesity scheduled for bariatric surgery: A single center experience.

We aim to assess the prevalence of vitamin D deficiency (VDD) in patients scheduled for bariatric surgery (BS), and to identify factors that might be associated with VDD. We conducted a cross-sectional observational study involving all consecutive patients scheduled for BS from 2017 to 2019. The exclusion criteria were missing data for vitamin D levels, intake of vitamin D supplements in the 3 months prior to serum vitamin D determination, and renal insufficiency. A total of 206 patients (mean age and body mass index [BMI] of 34.9 ± 10.7 years, and 44.3 ± 6.99 kg/m2, respectively) met the inclusion criteria and were enrolled for data analysis. VDD (<19.9 ng/mL), severe VDD (<10 ng/mL), and vitamin D insufficiency (20-29.9 ng/mL) were present in 68.8 %, 12.5 %, and 31.2 % of patients, respectively. A significant inverse correlation was found between vitamin D levels and initial BMI, parathyroid hormone, and homeostatic model assessment of insulin resistance (r = -0.280, p < 0.05; r = -0.407, p = 0.038; r = -0.445, p = 0.005), respectively. VDD was significantly more prevalent in patients with higher BMI [-0.413 ± 0.12, CI95 % (-0.659; -0.167), p = 0.006], whereas no significant association between hypertension [-1.005 ± 1.65, CI95 % (-4.338; 2.326), p = 0.001], and diabetes type 2 (T2D) [-0.44 ± 2.20, CI95 % (-4.876; 3.986), p = 0.841] was found. We observed significant association between female sex and levels of vitamin D [6.69 ± 2.31, CI95 % (2.06; 11.33), p = 0.006]. The present study shows that in patients scheduled for BS, VDD deficiency is common and was associated with higher BMI, and female sex.

Erythrocyte deformability and aggregation in morbidly obese women undergoing laparoscopic gastric bypass surgery and effects of oral omega-3 fatty acid supplementation.

BACKGROUND: An adequate erythrocyte function is vital for tissue oxygenation and wound healing. The erythrocyte membrane phospholipid composition plays an important role in erythrocyte function and administration of omega-3 fatty acids may provide a means to improve it. OBJECTIVE: To investigate peri-operative erythrocyte function and effects of oral omega-3 fatty acids in morbidly obese women undergoing gastric bypass surgeryMETHODS:Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery were randomized between a low calorie diet (LCD) during 2 weeks or oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs) and a normal diet during 4 weeks. Peri-operative blood samples were analyzed with the Lorrca MaxSIS Ektacytometer for erythrocyte deformability and aggregability. RESULTS: There were no significant differences in erythrocyte function between the groups at any time point. Only erythrocyte aggregability parameters were affected by surgery. At six month follow-up, aggregation index (AI) and cholesterol, glucose and insulin were significantly improved. CONCLUSIONS: In this study, oral Omega-3 supplementation did not affect erythrocyte function compared to a LCD. Six months after surgery a significant improvement in AI and metabolic parameters was observed in both groups, contributing to a reduction in the risk at thromboembolic and cardiovascular complications.

The comparison of morbid obesity quality of life and body image between surgery and other treatments: A case-control study.

BACKGROUND: Morbid obesity is rising around the world. Surgery is a selective treatment intervention for it. Since most of the surgeons use weight loss for evaluating of the morbid obesity surgical outcomes and paying attention to the the quality of life (QOL) and body image evaluation are rare, this study aimed to assess the QOL and body image in pre- and postsurgery with other interventions. MATERIALS AND METHODS: This case-control study was done on 200 morbidly obese patients (n = 100 in each group) who referred to the obesity clinic in Shiraz. The data were collected by Body Image Concern Inventory and 12-item Short Form Survey. The data were analyzed by t-test, Pearson correlation coefficient test, analysis of variance, and regression analysis. P = 0.05 was considered as significant. RESULTS: The paired t-test showed a significant difference in mean scores of body image (P < 0.001) and all dimensions of the QOL (P < 0.001) in the case and control groups. In the case group, there was a significant difference between the mean scores of the QOL and the different categories of body mass index (BMI) in postsurgery (P < 0.05) and the different mean scores of body image and the different categories of BMI in pre- and postsurgery wasn't significant (P > 0.05). Age was a predictor variable for the QOL of morbidly obese persons after surgery (P < 0.001). After surgery, men showed better QOL than women (P < 0.001). CONCLUSION: Final results indicated that body image and QOL defects caused by obesity could be more improvement after surgery. This study can promote health-care team's knowledge about holistic supporting of all dimensions' QOL of obese individuals. It is suggested that supporting interventions should be done as effective methods of maintenance for effects of weight loss methods such as surgery.

Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

BACKGROUND AND AIMS: To assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated. METHOD: In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 ± 0.7 kg/m2) were implanted with the Exilis™ system. Amplitude of the Exilis™ system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks. RESULTS: The procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203 ± 16 vs. 212 ± 14 min, p > 0.05), food intake (713 ± 68 vs. 799 ± 69 kcal, p > 0.05), insulin AUC (2448 ± 347 vs. 2186 ± 204, p > 0.05), and glucose AUC (41 ± 2 vs.41 ± 2, p > 0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p < 0.01) reduction in weight loss was observed but not at week 52. At this time point, the mean excess weight loss (EWL) was 14.2 ± 4.5%. CONCLUSION: Gastric electrical stimulation with the Exilis™ system can be considered as safe. No significant effect on food intake, gastric emptying, or gastric motility was observed. The reduction in weight loss with Exilis™ GES was significant but short lasting. Further electrophysiological research is needed to gain more insight in optimal stimulation parameters and lead localization.

Cardia Gastric Cancer in the Gastric Pouch 5 Years after Gastric Bypass: A Case Report.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is one of the most frequently performed bariatric procedures worldwide. Remnant gastric cancer after RYGB is a rare complication. There were about seventeen cases reported in the world. The location of the tumor in these cases occurs mainly in the gastric antrum, followed by the body, then the pylorus and linitis plastica, and the last was fundus of the stomach. To the best of our knowledge, this is the first case that gastric cancer located in the cardia of stomach after RYGB. CASE REPORT: A 68-year-old male patient had chronic esophagitis, bile reflux gastritis, and erosive antral gastritis 5 years after RYGB and now developed to aggressive carcinoma in the gastric pouch. In spite of having chemotherapy and traditional Chinese medicine therapy, the patient died of multiple organ failure after 15 months. CONCLUSIONS: This case report highlights the importance to have gastroscopy to observe the proximal small remnant stomach after RYGB in long-term follow-up. Attention must be paid when patients develop symptoms like abdominal pain or excessive weight loss after RYGB. For patients at high risk such as those who have a family history of gastric cancer or presenting abnormal levels of tumor markers should rather undergo Sleeve Gastrectomy plus Jejunojejunal Bypass (SGJB) instead of RYGB.

The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT.

BACKGROUND: Since a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient. OBJECTIVE: The present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS). DESIGN: A double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance. RESULTS: In total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. CONCLUSIONS: This optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. CLINICAL TRIAL REGISTRY: The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).

Bone metabolism in Chinese patients after laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass is a leading metabolic surgery for obese patients with type 2 diabetes mellitus. However, postoperative nutritional deficiencies and abnormal bone metabolism are possible. In this study, we investigated the mid-term impact on bone metabolism of laparoscopic Roux-en-Y gastric bypass. METHODS: This retrospective study involved 238 patients with type-2 diabetes mellitus and obesity who underwent laparoscopic Roux-en-Y gastric bypass in our institution; patients were followed for 3 years. Patients received a calcium supplement (1,200 mg per day), alfacalcidol (0.5 µg per day), and a multivitamin (1 tablet per day), postoperatively. We recorded and analyzed patients' body mass index, and blood levels of 25-hydroxy-vitamin D, calcium, and parathyroid hormone. Data for 16 patients 6 months postoperatively were selected randomly to evaluate bone-specific alkaline phosphatase and the bone resorption marker, C-terminal crosslinking telopeptide of type I collagen (CTX-1). RESULTS: Of the 238 patients, 111 were women, and 127 were men (mean age: 46.91±12.03 years; mean body mass index: 31.37 kg/m2). 25-hydroxy vitamin D3 levels did not change (P>0.05) compared with preoperative levels during the 3-year follow-up. Parathyroid hormone (PTH) levels increased (P<0.05), while serum calcium decreased (P<0.05). Patients' body mass index decreased sharply 3 months postoperatively (preoperative vs. postoperative mean: 31.37±3.52 vs. 25.60±2.86, respectively; P<0.05). We saw no decrease in 25-hydroxy vitamin D3 levels with supplementation, postoperatively. CTX-1 and bone-specific alkaline phosphatase levels showed no significant changes comparing pre- and postoperative levels at 6-, 12-, and 24 months (P>0.05). However, CTX-1 levels increased in the first 12 months postoperatively, then decreased in the second year; bone alkaline phosphatase levels increased gradually. CONCLUSIONS: Laparoscopic Roux-en-Y gastric bypass is effective for weight loss, but also has an impact on bone metabolism, which increases the risk of fracture. Our results highlight the importance of regular follow-ups and full-dose calcium and vitamin supplementation, postoperatively.

Rivaroxaban versus warfarin treatment among morbidly obese patients with venous thromboembolism: Comparative effectiveness, safety, and costs.

INTRODUCTION: Limited data exist on direct-acting oral anticoagulants in morbidly obese patients with venous thromboembolism (VTE). We compared clinical and health/economic outcomes with rivaroxaban versus warfarin for VTE treatment in morbidly obese patients. MATERIALS AND METHODS: This retrospective 1:1 propensity score matched cohort study analyzed data from 2 US claims databases. VTE patients initiating rivaroxaban or warfarin were identified who had diagnosis codes for morbid obesity (ICD-9:278.01,V85.4; ICD-10:E66.01,E66.2,Z68.4) 12 months pre- or 3 months post-initiation and followed ≥3 months. Intent-to-treat (ITT) and on-treatment (OT) analyses were conducted using conditional logistic regression and generalized linear models to compare recurrent VTE and major bleeding risks, healthcare resource utilization (HRU), and per patient per year (PPPY) costs. RESULTS: In total, 2890 matched pairs of morbidly obese VTE patients initiating rivaroxaban or warfarin were identified. Risks of recurrent VTE (ITT: OR: 0.99; 95% CI: 0.85-1.14) and major bleeding (OT: OR: 0.75; 95% CI: 0.47-1.19) were similar for cohorts. Anti-Factor Xa laboratory measurement was performed on <1% of rivaroxaban cohort. Hospitalizations (OR: 0.86; 95% CI: 0.77-0.96) and outpatient visits (OR: 0.23; 95% CI: 0.10-0.56), were lower with rivaroxaban versus warfarin (ITT analysis). Average total medical costs PPPY were $2829 lower with rivaroxaban versus warfarin ($34,824 vs $37,653), mainly driven by hospitalization costs. Total healthcare costs (including pharmacy) were similar ($43,034 vs $44,565). CONCLUSIONS: Morbidly obese VTE patients receiving rivaroxaban had similar risks of recurrent VTE and major bleeding versus warfarin. Rivaroxaban treatment yielded significantly less HRU and total medical costs, with similar total healthcare costs between groups.