BACKGROUND:The very-low-calorie ketogenic diet (VLCKD) is increasingly used before bariatric surgery (BS), but its effects on surgical and long-term outcomes remain unclear. OBJECTIVE:The aim of this study was to compare the impact of a 4-week VLCKD with a 4-week low-calorie diet (LCD) on preoperative, perioperative and postoperative outcomes for up 12 months in patients undergoing BS. METHODS:In this prospective study, 72 (n = 36: VLCKD; n = 36: LCD) patients (mean age 43.2 ± 10.6 years; BMI 45.6 ± 6.4 kg/m2; 87.5% female) submitted to sleeve gastrectomy were enrolled at a tertiary care center from 2022 to 2024. RESULTS:No adverse events were detected with both diets. The VLCKD was associated with a greater preoperative median weight loss percentage (-5.5 vs. -2.6 kg, p < 0.001), BMI reduction (-2.6 vs. -1.2 kg/m2, p < 0.001), shorter hospital stay (3.0 ± 0.2 vs. 3.4 ± 0.9 days, p = 0.017), higher day-1 postoperative hemoglobin (12.7 ± 1.3 vs. 12.0 ± 1.2 g/dL, p = 0.024), and lower day-1 postoperative median C-reactive protein levels (9.7 vs. 13.4 mg/L, p = 0.042). These associations were confirmed in a multiple regression model, after adjustments for BMI at enrolment, age and sex. After 6 months, the VLCKD was associated with greater reductions in mean weight loss percentage (-24.9 ± 7.8 vs. -19.6 ± 9.4 kg, p = 0.012), BMI reduction (-11.7 ± 4.4 vs. -8.7 ± 3.9 kg/m2, p = 0.003), neck circumference (-4.9 vs. -3.6 cm, p = 0.027) and lower aminotransferase levels. At 12 months, VLCKD patients maintained significant advantages over the same variables, except for neck circumference. CONCLUSIONS:A short preoperative VLCKD was safe and was associated with greater short-term weight reduction compared with the LCD, with potential benefits extending to early postoperative recovery and 1-year outcomes.
BACKGROUND:Micronutrient deficiencies (MD) are highly prevalent among candidates for bariatric surgery (BS) and are associated with adverse perioperative and postoperative outcomes. Although guidelines recommend systematic preoperative screening and correction, conventional targeted supplementation (CTS) often requires multiple products, potentially limiting adherence and delaying surgical readiness. Bariatric-specific multivitamins (BSM) may simplify nutritional management, but their real-world effectiveness for preoperative correction of multiple MD remains insufficiently investigated. OBJECTIVE:To compare the effectiveness, efficiency, and adherence of a BSM versus CTS for preoperative correction of multiple MD in BS candidates. METHODS:This retrospective multicenter cohort study included 1560 adults with obesity evaluated for BS between 2020 and 2024 across three Italian bariatric centers. The primary efficacy analysis was restricted to patients presenting with ≥3 laboratory-confirmed MD at baseline. Patients treated between 2020 and 2022 received individualized CTS using multiple products, whereas those treated between 2023 and 2024 received a single BSM. Biochemical follow-up was scheduled at 4 and 8 weeks. The primary outcome was the achievement of complete biochemical correction of all baseline deficiencies at the predefined 4-week follow-up assessment (composite endpoint). Secondary outcomes included supplementation burden and self-reported adherence. Early correction rates were compared using absolute risk differences and risk ratios; adjusted associations were evaluated using multivariable regression models including center and baseline deficiency burden. As a supplementary analysis, the patient-level proportion of baseline deficiencies corrected at 4 weeks was also evaluated. RESULTS:Among patients with ≥3 baseline deficiencies (n = 216), complete biochemical correction at 4 weeks was achieved in 55/134 patients (41.0%) in the BSM group and in 13/82 patients (15.9%) in the CTS group, corresponding to an absolute risk difference of 25.2 percentage points (95% CI 7.8-40.0) and a risk ratio of 2.59 (95% CI 1.51-4.44). In adjusted analyses accounting for center and baseline deficiency pattern, BSM use remained independently associated with early complete correction (adjusted absolute risk difference 26.3 percentage points; adjusted risk ratio 2.69). Sensitivity analyses restricting follow-up timing and excluding early calendar periods yielded consistent results. The mean proportion of baseline deficiencies corrected per patient at 4 weeks was higher in the BSM group compared with CTS (0.74 ± 0.25 vs. 0.54 ± 0.30). Compared with CTS, BSM was associated with lower supplementation burden (1 vs. 3.5 supplements on average) and higher adherence (92% vs. 70%). CONCLUSIONS:In a real-world multicenter cohort of BS candidates with ≥3 baseline MD, a simplified preoperative supplementation strategy based on a BSM was associated with a significantly higher probability of complete biochemical correction at 4 weeks, lower supplementation burden, and higher reported adherence compared with CTS. Although complete correction was not universal at 4 weeks, BSM significantly increased the likelihood of achieving early multi-deficiency normalization. Given the non-concurrent observational design, these findings should be interpreted as hypothesis-generating and warrant confirmation in prospective studies with concurrent cohorts.
Obesity is a chronic disease associated with increased morbidity and mortality and reduced quality of life. Pharmacotherapy can be associated with life style interventions aiming at increasing and maintaining weight loss and ameliorating obesity-related medical conditions. In patients affected by obesity and uncontrolled obesity-associated complications or high degree of BMI (> 40 kg/m2), metabolic bariatric surgery (MBS) can be a feasible therapeutic option. Many different types of surgical procedures have been developed in last decades, mainly performed via laparoscopic approaches. However, clinical indications for MBS and the selection of the most appropriate type of procedure have not been clarified so far. The Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to design and develop the updated version of the Italian guidelines aimed at assisting healthcare professionals in the choice of the surgical option for the treatment of obesity and related medical conditions. Between June and October 2022, a panel of 24 experts and an evidence review team (ERT, 10 members), participated in the definition of clinical questions, outcomes, and recommendations and collected and analyzed all the available evidence on the basis of pre-specified search strategies. GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology and PICO (Patient, Intervention, Comparison, Outcome) conceptual framework have been adopted for the development of the present guidelines. The aim of the present guideline is to verify indications to bariatric surgical endoscopy with respect to the presence of comorbid conditions, evaluate the different types of endoscopic bariatric procedure and revise indication to revisional bariatric endoscopy and postoperative procedures.
Objective: To assess the complementary role of the Body Mass Index (BMI) and Edmonton Obesity Staging System (EOSS) in predicting all-cause and cause-specific mortality in people living with overweight and obesity (PLwOW/O). Methods: A longitudinal analysis of prospectively collected data from the 1999-2018 cycles of the National Health and Nutrition Examination Survey (NHANES) was conducted. The association between BMI, EOSS, and mortality was evaluated through Cox regression models, adjusted for confounders. Results: The analysis included 36,529 subjects; 5329 deaths occurred over a median follow-up of 9.1 years (range: 0-20.8). An increased mortality risk was observed for obesity class II and III (HR = 1.21, 95% CI 1.08-1.36, p = 0.001 and HR = 1.58, 95% CI 1.39-1.80, p < 0.001; compared to overweight), and for EOSS stage 2 and 3 (HR = 1.36, 95% CI 1.16-1.58, p < 0.001 and HR = 2.66, 95% CI 2.26-3.14, p < 0.001; compared to stage 0/1). The prognostic role of BMI was more pronounced in younger patients, males, and non-Black individuals, while that of EOSS was stronger in women. Both BMI and EOSS independently predicted cardiovascular- and diabetes-related mortality. EOSS stage 3 was the only predictor of death from malignancy or renal causes. Conclusions: BMI and EOSS independently predict all-cause and cause-specific mortality in PLwOW/O. Their integrated use seems advisable to best define the obesity-related mortality risk.
Obesity/overweight and its complications are a growing problem in many countries. Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to develop the first Italian guidelines for the endoscopic bariatric treatment of obesity. The creation of SICOB Guidelines is based on an extended work made by a panel of 44 members and a coordinator. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide the aims, reference population, and target health professionals. Clinical questions have been created using the PICO (patient, intervention, comparison, outcome) conceptual framework. We will perform systematic reviews, formal meta-analyses, and network meta-analyses for each PICO and critical outcomes aimed at assessing and rating the efficacy and safety of endoscopic bariatric procedures in comparison with either no interventions, lifestyle interventions, or approved anti-obesity treatments in trials with a follow-up of at least 52 weeks. For PICO on temporary endoscopic bariatric treatments, we will also consider RCT with a minimum duration of 6 months. The panel proposed 8 questions, organized into four domains: A. Indication for endoscopic bariatric surgery; B. Revisional surgery; C. Temporary gastric and duodenal–jejunal procedures; D. Endoscopic diagnosis/treatment of bariatric and metabolic surgery complications. These guidelines will apply to patients aged ≥ 14 years) with body mass index (BMI) ≥ 27 kg/m2 and requiring endoscopic bariatric surgery or endoscopic diagnostic and/or therapeutic procedures. The areas covered by the clinical questions included indications of endoscopic bariatric surgery, types of surgery, revisional surgery, and management of bariatric and metabolic surgery complications.
Objectives: Sleeve gastrectomy (SG) is one of the most commonly performed weight loss (WL) bariatric procedures. The main goal of WL is reducing total body weight (TBW) and fat mass (FM). However, TBW loss is systematically accompanied by a decline in fat-free mass (FFM), predominantly in the first post-surgical month, despite protein supplementation. Branched-chain amino acids (BCAAs) and vitamin D seem to attenuate loss of FFM and, thus, reduce the decline in muscle strength (MS). However, data on the role of an integrated supplementation with whey protein plus BCAAs plus vitamin D (P+BCAAs+Vit.D) vs. protein alone on total weight loss (TWL), fat mass (FM), fat-free mass (FFM), and (MS) in the first month after SG are lacking. Therefore, the present study aims to evaluate the impact of P+BCAAs+Vit.D vs. protein alone supplementation on TWL, FM, FFM, and MS in the first month after SG. Materials and Methods: Before SG and at 1 month afterward, we prospectively measured and compared TBW, FM, FFM, and MS in 57 patients who received either a supplementation with P+BCAAs+Vit.D (n = 31) or protein alone (n = 26). The impact of P+BCAAs+Vit.D and protein alone supplementation on clinical status was also evaluated. Results: Despite non-significant variation in TBW, FM decreased more significantly (18.5% vs. 13.2%, p = 0.023) with the P+BCAA+Vit.D supplementation compared to protein alone. Furthermore, the P+BCAA+Vit.D group showed a significantly lower decrease in FFM (4.1% vs. 11.4%, p < 0.001) and MS (3.8% vs. 18.5%, p < 0.001) compared to the protein alone group. No significant alterations in clinical status were seen in either group. Conclusion: P+BCAA+Vit.D supplementation is more effective than protein alone in determining FM loss and is associated with a lower decrease in FFM and MS, without interfering with clinical status in patients 1 month after SG.
Adults with obesity have a higher risk of hospitalization and high hospitalization-related healthcare costs. However, a predictive model for the risk of readmission in patients with severe obesity is lacking. We conducted a retrospective cohort study enrolling all patients admitted for severe obesity (BMI ≥ 40 kg/m2) between 2009 and 2018 to the Istituto Auxologico Italiano in Piancavallo. For each patient, all subsequent hospitalizations were identified from the regional database by a deterministic record-linkage procedure. A total of 1136 patients were enrolled and followed up for a median of 5.7 years (IQR: 3.1–8.2). The predictive factors associated with hospital readmission were age (HR = 1.02, 95%CI: 1.01–1.03, p < 0.001), BMI (HR = 1.02, 95%CI: 1.01–1.03, p = 0.001), smoking habit (HR = 1.17, 95%CI: 0.99–1.38, p = 0.060), serum creatinine (HR = 1.22, 95%CI: 1.04–1.44, p = 0.016), diabetes (HR = 1.17, 95%CI: 1.00–1.36, p = 0.045), and number of admissions in the previous two years (HR = 1.15, 95%CI: 1.07–1.23, p < 0.001). BMI lost its predictive role when restricting the analysis to readmissions within 90 days. BMI and diabetes lost their predictive roles when further restricting the analysis to readmissions within 30 days. In conclusion, in this study, we identified predictive variables associated with early and long-term hospital readmission in patients with severe obesity. Whether addressing modifiable risk factors could improve the outcome remains to be established.
The metabolic benefits of time-restricted eating (TRE) in humans are statistically significant but not clinically relevant. Few data are available about the effects of TRE on the gut microbiota. We compared the effects of a TRE regimen (<12 h feeding; n = 25) with a time-unrestricted (TUE) regimen (>12 h feeding; n = 24), on the clinical and dietary variables and gut-microbiota composition in patients with obesity, who were subjected for 12 weeks to the same caloric restriction. Median weight loss was 4.0 kg and 2.2 kg in the TRE and TUE groups, respectively, with a between-group borderline difference (p = 0.049). No significant between-group difference was found in other dietary, anthropometric, or laboratory variables. There were no substantial between-group differences in alpha and beta diversity or gut-microbiota composition. The TRE group showed a significant increase in the frequency of Lachnospiraceae, Parasutterella, and Romboutsia at the study’s end. A TRE regimen induced small changes both in metabolic/dietary variables and in the gut-microbiota composition, with respect to the TUE. The microbial changes we have found were of uncertain clinical significance.
Bariatric surgery (BS) is an effective treatment for morbid obesity. However, a simple and easy-to-use tool for the prediction of BS unsuccess is still lacking. Baseline and follow-up data from 300 consecutive patients who underwent BS were retrospectively collected. Supervised regression and machine-learning techniques were used for model development, in which BS unsuccess at 2 years was defined as a percentage of excess-weight-loss (%EWL) < 50%. Model performances were also assessed considering the percentage of total-weight-loss (%TWL) as the reference parameter. Two scoring systems (NAG-score and ENAG-score) were developed. NAG-score, comprising only pre-surgical data, was structured on a 4.5-point-scale (2 points for neck circumference ≥ 44 cm, 1.5 for age ≥ 50 years, and 1 for fasting glucose ≥ 118 mg/dL). ENAG-score, including also early post-operative data, was structured on a 7-point-scale (3 points for %EWL at 6 months ≤ 45%, 1.5 for neck circumference ≥ 44 cm, 1 for age ≥ 50 years, and 1.5 for fasting glucose ≥ 118 mg/dL). A 3-class-clustering was proposed for clinical application. In conclusion, our study proposed two scoring systems for pre-surgical and early post-surgical prediction of 2-year BS weight-loss, which may be useful to guide the pre-operative assessment, the appropriate balance of patients’ expectations, and the post-operative care.
Objective: The usefulness of the rapid-induction techniques of hypnosis as an adjunctive weight-loss treatment has not been defined. This randomized controlled trial evaluated whether self-conditioning techniques (self-hypnosis) added to lifestyle interventions contributed to weight loss (primary outcome), changes in metabolic and inflammatory variables, and quality of life (QoL) improvement (secondary outcomes) in severe obesity. Methods: Individuals (with BMI = 35-50 kg/m(2)) without organic or psychiatric comorbidity were randomly assigned to the intervention (n = 60) or control arm (n = 60). All received exercise and behavioral recommendations and individualized diets. The intervention consisted of three hypnosis sessions, during which self-hypnosis was taught to increase self-control before eating. Diet, exercise, satiety, QoL, anthropometric measurements, and blood variables were collected and measured at enrollment and at 1 year (trial end). Results: A similar weight loss was observed in the intervention (-6.5 kg) and control (-5.6 kg) arms (beta = -0.45; 95% CI: -3.78 to 2.88; P = 0.79). However, habitual hypnosis users lost more weight (-9.6 kg; (beta = -10.2; 95% CI: -14.2 to -6.18; P < 0.001) and greatly reduced their caloric intake (-682.5 kcal; p = -643.6; 95% CI: -1064.0 to -223.2; P = 0.005) in linear regression models. At trial end, the intervention arm showed lower C-reactive protein values (beta= -2.55 mg/L; 95% CI: -3.80 to -1.31; P < 0.001), higher satiety score (beta = 19.2; 95% CI: 7.71-30.6; P = 0.001), and better QoL (EuroQol health status) = 0.09; 95% CI: 0.02-0.16; P = 0.01). Conclusions: Self-hypnosis was not associated with differences in weight change but was associated with improved satiety, QoL, and inflammation. Indeed, habitual hypnosis users showed a greater weight loss.
Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesity Methods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach. Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables. Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.