Advice of General Practitioner, of Surgeon, of Endocrinologist, and Self-determination: the Italian Road to Bariatric Surgery.

PURPOSE: Bariatric surgery (BS) is considered the most efficient treatment for severe obesity. International guidelines recommend multidisciplinary approach to BS (general practitioners, endocrinologists, surgeons, psychologists, or psychiatrists), and access to BS should be the final part of a protocol of treatment of obesity. However, there are indications that general practitioners (GPs) are not fully aware of the possible benefits of BS, that specialty physicians are reluctant to refer their patients to surgeons, and that patients with obesity choose self-management of their own obesity, including internet-based choices. There are no data on the pathways chosen by physicians and patients to undergo BS in the real world in Italy. METHODS: An exploratory exam was performed for 6 months in three pilot regions (Lombardy, Lazio, Campania) in twenty-three tertiary centers for the treatment of morbid obesity, to describe the real pathways to BS in Italy. RESULTS: Charts of 2686 patients (788 men and 1895 women, 75.5% in the age range 30-59 years) were evaluated by physicians and surgeons of the participating centers. A chronic condition of obesity was evident for the majority of patients, as indicated by duration of obesity, by presence of several associated medical problems, and by frequency of previous dietary attempts to weight loss. The vast majority (75.8%) patients were self-presenting or referred by bariatric surgeons, 24.2% patients referred by GPs and other specialists. Self-presenting patients were younger, more educated, more professional, and more mobile than patients referred by other physicians. Patients above the age of 40 years or with a duration of obesity greater than 10 years had a higher prevalence of all associated medical problems. CONCLUSIONS: The majority of patients referred to a tertiary center for the treatment of morbid obesity have a valid indication for BS. Most patients self-refer to the centers, with a minority referred by a GP or by specialists. Self-presenting patients are younger, more educated, more professional, and more mobile than patients referred by other physicians. Older patients and with a longer duration of obesity are probably representative of the conservative approach to BS, often regarded as the last resort in an endless story.

Role of nutritional ketosis in the improvement of metabolic parameters following bariatric surgery.

BACKGROUND: Ketone bodies (KB) might act as potential metabolic modulators besides serving as energy substrates. Bariatric metabolic surgery (BMS) offers a unique opportunity to study nutritional ketosis, as acute postoperative caloric restriction leads to increased lipolysis and circulating free fatty acids. AIM: To characterize the relationship between KB production, weight loss (WL) and metabolic changes following BMS. METHODS: For this retrospective study we enrolled male and female subjects aged 18-65 years who underwent BMS at a single Institution. Data on demographics, anthropometrics, body composition, laboratory values and urinary KB were collected. RESULTS: Thirty-nine patients had data available for analyses [74.4% women, mean age 46.5 ± 9.0 years, median body mass index 41.0 (38.5; 45.4) kg/m2, fat mass 45.2% ± 6.2%, 23.1% had diabetes, 43.6% arterial hypertension and 74.4% liver steatosis]. At 46.0 ± 13.6 d post-surgery, subjects had lost 12.0% ± 3.6% of pre-operative weight. Sixty-nine percent developed ketonuria. Those with nutritional ketosis were significantly younger [42.9 (37.6; 50.7) years vs 51.9 (48.3; 59.9) years, P = 0.018], and had significantly lower fasting glucose [89.5 (82.5; 96.3) mg/dL vs 96.0 (91.0; 105.3) mg/dL, P = 0.025] and triglyceride levels [108.0 (84.5; 152.5) mg/dL vs 152.0 (124.0; 186.0) mg/dL, P = 0.045] vs those with ketosis. At 6 mo, percent WL was greater in those with postoperative ketosis (-27.5% ± 5.1% vs 23.8% ± 4.3%, P = 0.035). Urinary KBs correlated with percent WL at 6 and 12 mo. Other metabolic changes were similar. CONCLUSION: Our data support the hypothesis that subjects with worse metabolic status have reduced ketogenic capacity and, thereby, exhibit a lower WL following BMS.

Abdominal obesity phenotype is associated with COVID-19 chest X-ray severity score better than BMI-based obesity.

PURPOSE: Chest X-ray (CXR) severity score and BMI-based obesity are predictive risk factors for COVID-19 hospital admission. However, the relationship between abdominal obesity and CXR severity score has not yet been fully explored. METHODS: This retrospective cohort study analyzed the association of different adiposity indexes, including waist circumference and body mass index (BMI), with CXR severity score in 215 hospitalized patients with COVID-19. RESULTS: Patients with abdominal obesity showed significantly higher CXR severity scores and had higher rates of CXR severity scores ≥ 8 compared to those without abdominal obesity (P < 0.001; P = 0.001, respectively). By contrast, patients with normal weight, with overweight and those with BMI-based obesity showed no significant differences in either CXR severity scores or in the rates of CXR severity scores ≥ 8 (P = 0.104; P = 0.271, respectively). Waist circumference and waist-to-height ratio (WHtR) correlated more closely with CXR severity scores than BMI (r = 0.43, P < 0.001; r = 0.41, P < 0.001; r = 0.17, P = 0.012, respectively). The area under the curves (AUCs) for waist circumference and WHtR were significantly higher than that for BMI in identifying a high CXR severity score (≥ 8) (0.68 [0.60-0.75] and 0.67 [0.60-0.74] vs 0.58 [0.51-0.66], P = 0.001). A multivariate analysis indicated abdominal obesity (risk ratio: 1.75, 95% CI: 1.25-2.45, P < 0.001), bronchial asthma (risk ratio: 1.73, 95% CI: 1.07-2.81, P = 0.026) and oxygen saturation at admission (risk ratio: 0.96, 95% CI: 0.94-0.97, P < 0.001) as the only independent factors associated with high CXR severity scores. CONCLUSION: Abdominal obesity phenotype is associated with a high CXR severity score better than BMI-based obesity in hospitalized patients with COVID-19. Therefore, when visiting the patient in a hospital setting, waist circumference should be measured, and patients with abdominal obesity should be monitored closely. Level of evidence Cross-sectional descriptive study, Level V.

COVID-19 is associated with clinically significant weight loss and risk of malnutrition, independent of hospitalisation: A post-hoc analysis of a prospective cohort study.

BACKGROUND & AIMS: Coronavirus disease 2019 (COVID-19) may associate with clinical manifestations, ranging from alterations in smell and taste to severe respiratory distress requiring intensive care, that might associate with weight loss and malnutrition. We aimed to assess the incidence of unintentional weight loss and malnutrition in COVID-19 survivors. METHODS: In this post-hoc analysis of a prospective observational cohort study, we enrolled all adult (age ≥18 years) patients with a confirmed diagnosis of COVID-19 who had been discharged home from either a medical ward or the Emergency Department of San Raffaele University Hospital, and were re-evaluated after remission at the Outpatient COVID-19 Follow-Up Clinic of the same Institution from April 7, 2020, to May 11, 2020. Demographic, anthropometric, clinical and biochemical parameters upon admission were prospectively collected. At follow-up, anthropometrics, the mini nutritional assessment screening and a visual analogue scale for appetite were assessed. RESULTS: A total of 213 patients were included in the analysis (33% females, median age 59.0 [49.5-67.9] years, 70% overweight/obese upon initial assessment, 73% hospitalised). Sixty-one patients (29% of the total, and 31% of hospitalised patients vs. 21% of patients managed at home, p = 0.14) had lost >5% of initial body weight (median weight loss 6.5 [5.0-9.0] kg, or 8.1 [6.1-10.9]%). Patients who lost weight had greater systemic inflammation (C-reactive protein 62.9 [29.0-129.5] vs.48.7 [16.1-96.3] mg/dL; p = 0.02), impaired renal function (23.7% vs. 8.7% of patients; p = 0.003) and longer disease duration (32 [27-41] vs. 24 [21-30] days; p = 0.047) as compared with those who did not lose weight. At multivariate logistic regression analysis, only disease duration independently predicted weight loss (OR 1.05 [1.01-1.10] p = 0.022). CONCLUSIONS: COVID-19 might negatively impact body weight and nutritional status. In COVID-19 patients, nutritional evaluation, counselling and treatment should be implemented at initial assessment, throughout the course of disease, and after clinical remission. CLINICALTRIALS. GOV REGISTRATION: NCT04318366.

Enrichment of Tc1 cells and T cell resistance to suppression are associated with dysglycemia in the visceral fat in human obesity.

OBJECTIVE: Insulin resistance, defined as tissue inflammation leading to type 2 diabetes, is a feature of obesity. The immune system has been implicated in its pathogenesis, but the role of adaptive immunity in humans remains uncertain. Here, we aim to determine whether specific phenotypic and functional properties of visceral adipose tissue (VAT)-derived CD4 conventional T cells (Tconv) and CD8 T cells are associated with dysglycemia in human obesity. RESEARCH DESIGN AND METHODS: Peripheral blood and the stromal vascular fraction of obese patients without dysglycemia (n=23), with impaired fasting glucose or type 2 diabetes (n=17), and non-diabetic lean controls (n=11) were studied. Characterization of memory, activation profile, cytokine production, proliferative capacity, cytotoxic potential and transforming growth factor-ß-mediated suppression of CD4 Tconv and CD8 T cells was performed. Correlation between anthropometric/metabolic parameters and VAT-derived T cell subsets was determined. RESULTS: In the VAT of the overall obese population, reduced frequency of interferon-γ-producing or tumor necrosis factor-α-producing CD4 (ie, T helper 1, Th1) and CD8 (ie, cytotoxic type 1, Tc1) T cells, as well as interleukin-17-producing CD8 T cells (ie, Tc17), was evident when compared with lean controls. However, enrichment of Tc1 cells, together with the impaired ability of CD4 and CD8 T cells to be suppressed, distinguished the visceral fat of obese patients with dysglycemia from the one of non-diabetic obese patients. Moreover, accumulation of Th1 and Tc1 cells in the VAT correlated with anthropometric and metabolic parameters. CONCLUSIONS: Here, we define the VAT-specific characteristics of T cells in human obesity, showing that accumulation of Tc1 cells and T cell resistance to suppression can be harmful to the development of obesity-induced diabetes. These findings open new directions to investigate immunological targets in the obesity setting.

A 9 years comparison of weight loss, disappearance of obesity, and resolution of diabetes mellitus with biliointestinal bypass and with adjustable gastric banding: experience of a collaborative network.

AIMS: Long-term comparisons between bariatric surgical techniques have been performed for gastric bypass (RYGB), sleeve gastrectomy (LSG), and biliopancreatic diversion (BPD) vs gastric banding (LAGB), but short-term studies (6 months-4 years) have only compared biliointestinal bypass (BIBP) and LAGB. The participating institutions regularly perform both BIBP and LAGB with a common protocol, and the aim of this retrospective study was to compare long-term effects of the two procedures on body weight, on clinical and metabolic variables, and on resolution of obesity and of diabetes. METHODS: All procedures performed between 01/01/1998 and 31/12/2005 were considered; 73 out of 91 patients undergoing BIBP, and 154 out of 249 patients undergoing LAGB were evaluable up to 9 years. RESULTS: BIBP was significantly more effective than LAGB in terms of weight loss and of resolution of obesity (BMI < 30 kg/m2), in terms of decrease of systolic blood pressure and of serum cholesterol, and similar in terms of resolution of diabetes. In addition, the effect of BIBP was stable, while the effect of LAGB decreased with time. CONCLUSIONS: Both BIBP and LAGB exert long-term effects on body weight, on blood pressure, and on resolution of diabetes mellitus; the effect of BIBP is significantly greater than the effect of LAGB in terms of weight loss, resolution of obesity, of control of systolic blood pressure and of serum cholesterol, but not in terms of resolution of diabetes.

A 23-year study of mortality and development of co-morbidities in patients with obesity undergoing bariatric surgery (laparoscopic gastric banding) in comparison with medical treatment of obesity.

BACKGROUND AND AIM: Several studies have shown that bariatric surgery reduces long term mortality compared to medical weight loss therapy. In a previous study we have demonstrated that gastric banding (LAGB) is associated with reduced mortality in patients with and without diabetes, and with reduced incidence of obesity co-morbidities (cardiovascular disease, diabetes, and cancer) at a 17 year follow-up. The aim of this study was to verify at a longer time interval (23 years) mortality and incidence of co-morbidities in patients undergoing LAGB or medical weight loss therapy. PATIENTS AND METHODS: As reported in the previous shorter-time study, medical records of obese patients [body mass index (BMI) > 35 kg/m2 undergoing LAGB (n = 385; 52 with diabetes) or medical treatment (controls, n = 681; 127 with diabetes), during the period 1995-2001 (visit 1)] were collected. Patients were matched for age, sex, BMI, and blood pressure. Identification codes of patients were entered in the Italian National Health System Lumbardy database, that contains life status, causes of death, as well as exemptions, prescriptions, and hospital admissions (proxies of diseases) from visit 1 to June 2018. Survival was compared across LAGB patients and matched controls using Kaplan-Meier plots adjusted Cox regression analyses. RESULTS: Final observation period was 19.5 ± 1.87 years (13.4-23.5). Compared to controls, LAGB was associated with reduced mortality [HR = 0.52, 95% CI 0.33-0.80, p = 0.003], significant in patients with diabetes [HR = 0.46, 95% CI 0.22-0.94, p = 0.034], borderline significant in patients without diabetes [HR = 0.61, 95% CI = 0.35-1.05, p = 0.076]. LAGB was associated with lower incidence of diabetes (15 vs 75 cases, p = 0.001), of CV diseases (61 vs 226 cases, p = 0.009), of cancer (10 vs 35, p = 0.01), and of renal diseases (0 vs 35, p = 0.001), and of hospital admissions (92 vs 377, p = 0.001). CONCLUSION: The preventive effect of LAGB on mortality is maintained up to 23 years, even with a decreased efficacy compared with the shorter-time study, while the preventive effect of LAGB on co-morbidities and on hospital admissions increases with time.

Long-term mortality and incidence of cardiovascular diseases and type 2 diabetes in diabetic and nondiabetic obese patients undergoing gastric banding: a controlled study.

BACKGROUND AND AIM: Aim of this retrospective study was to compare long-term mortality and incidence of new diseases [diabetes and cardiovascular (CV) disease] in morbidly obese diabetic and nondiabetic patients, undergoing gastric banding (LAGB) in comparison to medical treatment. PATIENTS AND METHODS: Medical records of obese patients [body mass index (BMI) > 35 kg/m(2) undergoing LAGB (n = 385; 52 with diabetes) or medical treatment (controls, n = 681; 127 with diabetes), during the period 1995-2001 (visit 1)] were collected. Patients were matched for age, sex, BMI, and blood pressure. Identification codes of patients were entered in the Italian National Health System Lumbardy database, that contains life status, causes of death, as well as exemptions, drug prescriptions, and hospital admissions (proxies of diseases) from visit 1 to September 2012. Survival was compared across LAGB patients and matched controls using Kaplan-Meier plots adjusted Cox regression analyses. RESULTS: Observation period was 13.9 ± 1.87 (mean ± SD). Mortality rate was 2.6, 6.6, and 10.1 % in controls at 5, 10, and 15 years, respectively; mortality rate was 0.8, 2.5, and 3.1 % in LAGB patients at 5, 10, and 15 years, respectively. Compared to controls, surgery was associated with reduced mortality [HR 0.35, 95 % CI 0.19-0.65, p < 0.001 at univariate analysis, HR 0.41, 95 % CI 0.21-0.76, p < 0.005 at adjusted analysis], similar in diabetic [HR 0.34, 95 % CI 0.13-0.87, p = 0.025] and nondiabetic [HR 0.42, 95 % CI 0.19-0.97, p = 0.041] patients. Surgery was also associated with lower incidence of diabetes (15 vs 48 cases, p = 0.035) and CV diseases (52 vs 124 cases, p = 0.048), and of hospital admissions (88 vs 197, p = 0.04). CONCLUSION: Up to 17 years, gastric banding is associated with reduced mortality in diabetic and nondiabetic patients, and with reduced incidence of diabetes and cardiovascular diseases.

Effects of gastric banding on glucose tolerance, cardiovascular and renal function, and diabetic complications: a 13-year study of the morbidly obese.

BACKGROUND: Limited information is available on weight loss, metabolic control, cardiovascular disease and diabetic complications in morbidly obese patients undergoing gastric banding (LAGB) compared with morbidly obese patients receiving medical treatment. OBJECTIVE: To assess the long-term effects of laparoscopic adjustable gastric banding (LAGB) on glucose tolerance, arterial hypertension, and cardiovascular disease and prevention of diabetic complications (retinopathy and renal function) in morbidly obese patients. SETTING: University hospitals, Italy. MATERIALS AND METHODS: In this retrospective study, 87 morbidly obese patients who underwent LAGB (20 with diabetes) and 87 morbidly obese patients who did not undergo surgery (36 with diabetes) for the treatment of obesity during the period 1995 to 2003 consented for re-examination after a mean (±standard deviation) period of 13.8±2.04 years. At baseline, all mobidly obese patients had a body mass index (BMI)≥35 kg/m(2) and were aged 18 to 65 years. RESULTS: At follow-up, LAGB patients maintained a lower weight compared with baseline values and demonstrated significant decreases in both blood pressure and heart rate measurements compared with control patients. LAGB patients also experienced greater improvement of glucose tolerance than did control patients (28% versus 10%, respectively; P<.01) and reduction of insulin and homeostasis model assessment for insulin resistance. Fewer LAGB patients developed carotid plaques than did control patients (10% versus 26%, respectively; P<.01). Intensification of antihypertensive therapy was required in 31% of surgery versus 60% of control patients (P<.05). Among diabetic patients, improved glucose tolerance occurred in 55% of surgery patients versus 0% in the control group (P<.01). In addition, insulin treatment was necessary in 9 control patients versus 0 in the surgery group (P<.05), and carotid plaques occurred in 10% of LAGB patients versus 50% of control patients (P<.01). Creatinine levels and the estimated glomerular filtration rate improved in LAGB diabetic patients but not in control patients (P< .05). CONCLUSION: Despite a very small weight loss over the long term (i.e., 2.2 kg/m(2)), improvement of glucose tolerance persisted for long periods after LAGB, with no unfavorable effect on kidney function and retinopathy. In contrast, no effect was observed on prevention of arterial hypertension or cardiovascular disease.

Metabolic syndrome, hypertension, and diabetes mellitus after gastric banding: the role of aging and of duration of obesity.

BACKGROUND: Bariatric surgery leads to resolution of arterial hypertension and diabetes mellitus; isolated reports indicate that response to bariatric surgery is lower in aged patients. The aim of this study was to evaluate the role of age and of duration of obesity on the frequency of co-morbidities in morbid obesity, as well as on improvement of co-morbidities. METHODS: A total of 837 consecutive patients with known duration of obesity, undergoing gastric banding, were considered for this study; they were divided into quartiles of age and of duration of obesity. Presence of co-morbidities (diabetes mellitus, arterial hypertension, metabolic syndrome), metabolic variables (cholesterol and HDL-C, triglycerides, blood glucose), anthropometric variables, and loss of weight during 24 months were considered. RESULTS: Older patients had a higher frequency of co-morbidities; duration of obesity only affected frequency of co-morbidities, but not response to surgery. At logistic regression, duration of obesity had a moderate independent effect on the frequency of diabetes. Older patients lost less weight than younger patients, but diabetes mellitus and arterial hypertension improved to the same extent in patients of different ages, and metabolic syndrome disappeared more in older patients, associated with a greater decrease of blood glucose. Frequency of removal of gastric banding and loss to follow-up were not different in different quartiles of age or in different quartiles of duration of obesity. CONCLUSION: Older patients, despite lower weight loss, have a response to bariatric surgery that is similar to that of younger patients; age and duration of obesity should not be considered as limits to indications to bariatric surgery.

Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR).

OBJECTIVE: Few studies have assessed the efficacy of carbohydrate counting in type 1 diabetes, and none have validated its efficacy in patients who are treated with continuous subcutaneous insulin infusion (CSII). The aim of our study was to test the effect of carbohydrate counting on glycemic control and quality of life in adult patients with type 1 diabetes who are receiving CSII. RESEARCH DESIGN AND METHODS: Sixty-one adult patients with type 1 diabetes treated with CSII were randomly assigned to either learning carbohydrate counting (intervention) or estimating pre-meal insulin dose in the usual empirical way (control). At baseline and 12 and 24 weeks, we measured HbA(1c), fasting plasma glucose, BMI, waist circumference, recorded daily insulin dose, and capillary glucose data, and administered the Diabetes-Specific Quality-of-Life Scale (DSQOLS) questionnaire. RESULTS: Intention-to-treat analysis showed improvement of the DSQOLS score related to diet restrictions (week 24 - baseline difference, P = 0.008) and reduction of BMI (P = 0.003) and waist circumference (P = 0.002) in the intervention group compared with control subjects. No changes in HbA(1c), fasting plasma glucose, daily insulin dose, and hypoglycemic episodes (<2.8 mmol/L) were observed. Per-protocol analysis, including only patients who continuously used carbohydrate counting and CSII during the study, confirmed improvement of the DSQOLS score and reduction of BMI and waist circumference, and showed a significant reduction of HbA(1c) (-0.35% vs. control subjects, P = 0.05). CONCLUSIONS: Among adult patients with type 1 diabetes treated with CSII, carbohydrate counting is safe and improves quality of life, reduces BMI and waist circumference, and, in per-protocol analysis, reduces HbA(1c).