Evaluating the Association of Obesity and Chronic Rhinosinusitis: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of this Meta-analysis and systematic review was to perform a comprehensive assessment of the association of chronic rhinosinusitis (CRS) with overweight/obesity, leptin hormone, and its associated metabolic dysregulation. DATA SOURCES: Ovid MEDLINE, Embase, Web of Science, and Cochrane Central Register of Controlled Trials, were searched for studies from 1946 to October 2022, using predefined syntax. REVIEW METHODS: Outcome data for the meta-analysis were extracted on odds ratios (OR) of CRS prevalence based on the presence of overweight/obesity and mean serum leptin levels. A Meta-analysis was performed using the DerSimonian-Laird estimator to pool extracted data by the generalized inverse variance approach. Random effect models were utilized due to the small sample size. A qualitative synthesis was performed on articles that did not meet the inclusion criteria for the Meta-analysis. RESULTS: Thirty-six studies met the systematic review inclusion criteria out of 1113 articles screened. A total of 6 studies were included in the pooled Meta-analysis of the various outcome variables. Our pooled meta-analysis observed a positive association between overweight/obesity and the prevalence of CRS (OR = 1.33, 95% confidence interval [CI]: 1.17-1.51). The pooled ratio of the means analysis of the mean serum leptin levels between CRS with nasal polyposis and control patients was 2.21 (95% CI: 1.45; 3.36). CONCLUSION: Our pooled Meta-analysis indicates a positive association between overweight/obesity and CRS. Future prospective studies are needed to explore the association between CRS and obesity with an understanding of potential confounding comorbidities, including studies focused on assessing the underlying immunologic mechanism of this association.

Severe Obesity Associated With Pituitary Corticotroph Hyperplasia and Neoplasia.

OBJECTIVE: To investigate the incidence of corticotroph hyperplasia (CH) or lymphocyte infiltration in the pituitary of patients with obesity. METHODS: The pituitary and adrenal glands from 161 adult autopsies performed between 2010 and 2019 at our institution were reviewed. The clinical history, body mass index (BMI), and cause of death were recorded. Routine hematoxylin and eosin staining, reticulin staining, and immunohistochemical staining for adrenocorticotropic hormone, CD3, and CD20 were performed. The results were analyzed using the Fisher and chi-square statistics. Decedents were separated into 4 groups based on BMI (kg/m2): (1) lean (BMI, <25.0), (2) overweight (BMI, 25.0-29.9), (3) obesity class I (BMI, 30.0-34.9), and (4) obesity classes II to III (BMI, >34.9). RESULTS: CH/neoplasia was identified in 44 of 161 pituitary glands. Four (9.1%) of 53 lean patients had pituitary lesions, whereas 27.3% (12) of overweight, 22.7% (10) of obesity class I, and 40.9% (18) of obesity class II patients had hyperplasia (P < .0001). Small corticotroph tumors were identified in 15 patients; only 1 was a lean patient, and the tumor was associated with the Crooke hyaline change of nontumorous corticotrophs. The presence of CH and neoplasia was associated with adrenal cortical hyperplasia and lipid depletion. Microscopic foci of T and B lymphocytes were identified in the pituitaries of patients in each weight category; no independent association between BMI and lymphocyte inflammation was found. CONCLUSION: Our data indicate an association between CH/neoplasia and obesity. It remains unclear whether obesity is the cause or effect of adrenocorticotropic hormone and cortisol excess.

Perioperative management of diabetes in patients undergoing bariatric and metabolic surgery: a narrative review and the Cleveland Clinic practical recommendations.

Bariatric and metabolic surgery is an effective treatment for patients with severe obesity and obesity-related diseases. In patients with type 2 diabetes, it provides marked improvement in glycemic control and even remission of diabetes. In patients with type 1 diabetes, bariatric surgery may offer improvement in insulin sensitivity and other cardiometabolic risk factors, as well as amelioration of the mechanical complications of obesity. Because of these positive outcomes, there are increasing numbers of patients with diabetes who undergo bariatric surgical procedures each year. Prior to surgery, efforts should be made to optimize glycemic control. However, there is no need to delay or withhold bariatric surgery until a specific glycosylated hemoglobin target is reached. Instead, treatment should focus on avoidance of early postoperative hyperglycemia. In general, oral glucose-lowering medications and noninsulin injectables are not favored to control hyperglycemia in the inpatient setting. Hyperglycemia in the hospital is managed with insulin, aiming for perioperative blood glucose concentrations between 80 and 180 mg/dL. Following surgery, substantial changes of the antidiabetic medication regimens are common. Patients should have a clear understanding of the modifications made to their treatment and should be followed closely thereafter. In this review article, we describe practical recommendations for the perioperative management of diabetes in patients with type 2 or type 1 diabetes undergoing bariatric surgery. Specific recommendations are delineated based on the different treatments that are currently available for glycemic control, including oral glucose-lowering medications, noninsulin injectables, and a variety of insulin regimens.

Lipids activate skeletal muscle mitochondrial fission and quality control networks to induce insulin resistance in humans.

BACKGROUND AND AIMS: A diminution in skeletal muscle mitochondrial function due to ectopic lipid accumulation and excess nutrient intake is thought to contribute to insulin resistance and the development of type 2 diabetes. However, the functional integrity of mitochondria in insulin-resistant skeletal muscle remains highly controversial. METHODS: 19 healthy adults (age:28.4 ±â€¯1.7 years; BMI:22.7 ±â€¯0.3 kg/m2) received an overnight intravenous infusion of lipid (20% Intralipid) or saline followed by a hyperinsulinemic-euglycemic clamp to assess insulin sensitivity using a randomized crossover design. Skeletal muscle biopsies were obtained after the overnight lipid infusion to evaluate activation of mitochondrial dynamics proteins, ex-vivo mitochondrial membrane potential, ex-vivo oxidative phosphorylation and electron transfer capacity, and mitochondrial ultrastructure. RESULTS: Overnight lipid infusion increased dynamin related protein 1 (DRP1) phosphorylation at serine 616 and PTEN-induced kinase 1 (PINK1) expression (P = 0.003 and P = 0.008, respectively) in skeletal muscle while reducing mitochondrial membrane potential (P = 0.042). The lipid infusion also increased mitochondrial-associated lipid droplet formation (P = 0.011), the number of dilated cristae, and the presence of autophagic vesicles without altering mitochondrial number or respiratory capacity. Additionally, lipid infusion suppressed peripheral glucose disposal (P = 0.004) and hepatic insulin sensitivity (P = 0.014). CONCLUSIONS: These findings indicate that activation of mitochondrial fission and quality control occur early in the onset of insulin resistance in human skeletal muscle. Targeting mitochondrial dynamics and quality control represents a promising new pharmacological approach for treating insulin resistance and type 2 diabetes. CLINICAL TRIAL REGISTRATION: NCT02697201, ClinicalTrials.gov.

Association of prior metabolic and bariatric surgery with severity of coronavirus disease 2019 (COVID-19) in patients with obesity.

BACKGROUND: Obesity is a risk factor for poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19). OBJECTIVES: To investigate the relationship between prior metabolic surgery and the severity of COVID-19 in patients with severe obesity. SETTING: Cleveland Clinic Health System in the United States. METHODS: Among 4365 patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between March 8, 2020 and July 22, 2020 in the Cleveland Clinic Health System, 33 patients were identified who had a prior history of metabolic surgery. The surgical patients were propensity matched 1:10 to nonsurgical patients to assemble a cohort of control patients (n = 330) with a body mass index (BMI) ≥ 40 kg/m2 at the time of SARS-CoV-2 testing. The primary endpoint was the rate of hospital admission. The exploratory endpoints included admission to the intensive care unit (ICU), need for mechanical ventilation and dialysis during index hospitalization, and mortality. After propensity score matching, outcomes were compared in univariate and multivariate regression models. RESULTS: The average BMI of the surgical group was 49.1 ± 8.8 kg/m2 before metabolic surgery and was down to 37.2 ± 7.1 at the time of SARS-CoV-2 testing, compared with the control group's BMI of 46.7 ± 6.4 kg/m2. In the univariate analysis, 6 (18.2%) patients in the metabolic surgery group and 139 (42.1%) patients in the control group were admitted to the hospital (P = .013). In the multivariate analysis, a prior history of metabolic surgery was associated with a lower hospital admission rate compared with control patients with obesity (odds ratio, 0.31; 95% confidence interval, 0.11-0.88; P = .028). While none of the 4 exploratory outcomes occurred in the metabolic surgery group, 43 (13.0%) patients in the control group required ICU admission (P = .021), 22 (6.7%) required mechanical ventilation, 5 (1.5%) required dialysis, and 8 (2.4%) patients died. CONCLUSION: Prior metabolic surgery with subsequent weight loss and improvement of metabolic abnormalities was associated with lower rates of hospital and ICU admission in patients with obesity who became infected with SARS-CoV-2. Confirmation of these findings will require larger studies.

Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.

SETTING: Bariatric surgery is indicated for patients diagnosed with obesity and type 2 diabetes. Many patients achieve type 2 diabetes remission soon after bariatric surgery. Even though most maintain good glycemic control, remission is not maintained in all patients, and as a result, some patients may relapse. Type 2 diabetes relapse is common in patients who regain weight; weight regain is prevalent 1 to 2 years after surgery. Additional pharmacotherapy may be required to aid bariatric surgery in fostering weight loss and reducing blood glucose levels. OBJECTIVES: The purpose of this clinical trial was to determine the effects of canagliflozin in participants who initially achieved type 2 diabetes remission but subsequently relapsed. METHODS: The double-blinded, randomized, and prospective study recruited participants (n = 16) roughly 3 years after bariatric surgery. The participants were followed for 6 months. RESULTS: Body mass index (-1.24 kg/m2) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo. There were improvements in body fat composition as denoted by reductions in android (-3.00%) and truncal (-2.67%) fat. Also, there were differences in blood glucose and hemoglobin A1C at 6 months. CONCLUSION: After bariatric surgery, canagliflozin improved weight loss and glycemic outcomes in participants with type 2 diabetes. Canagliflozin also facilitated improvements in body fat composition.

Testosterone replacement therapy and the risk of adverse cardiovascular outcomes and mortality.

BACKGROUND: The risk of adverse cardiovascular events and mortality associated with testosterone replacement therapy is controversial. The purpose of this report was to evaluate the effect of testosterone replacement therapy (TRT) in men with secondary hypogonadism on the risk of myocardial infarction (MI), stroke (CVA) or all-cause mortality. METHODS: A retrospective cohort study was conducted using the Cleveland Clinic's electronic health record. Men ≥40 years of age, with at least two testosterone levels < 220 ng/dL, with one level obtained between 7 am and 10 am, were identified. Men with primary hypogonadism, secondary hypogonadism related to overt hypothalamic pituitary pathology, human immunodeficiency virus infection, metastatic cancer, and select contraindications to TRT, were excluded. Men exposed to TRT were matched to controls that were not exposed. A survival analysis was performed on the composite outcome of MI, CVA, or all-cause mortality. RESULTS: One hundred sixty-five patients exposed to TRT (treatment group) were matched with 210 not exposed to TRT (comparison group). The prevalence of established cardiovascular disease (CVD) was 20.0% in the treatment group vs. 17.1% in the comparison group (P = 0.478). The median [interquartile range (IQR)] age (years) and BMI (kg/m2) were 55 (49, 62) and 35.6 (32.1, 40.1) in the treatment group, and 55 (49, 61.7) and 36.3 (32.1, 40.8) in the comparison group, respectively. There were 12 (7.3%) events observed in the treatment group, and 16 (7.6%) in the comparison group. The median time (years) to the composite event was 2.1 (IQR 0.9, 4.6) and 1.8 (IQR 0.6, 3.4) for treatment and comparison groups, respectively. No difference in the risk of the combined cardiovascular endpoint was observed between the treatment group vs the comparison group, hazard ratio (HR) 0.81 (95% Confidence Interval [CI]: 0.38-1.71; P = 0.57). CONCLUSION: In hypogonadal men with a modest prevalence of established CVD, TRT was not observed to confer a protective or adverse effect on the risk of MI, CVA or all-cause mortality.

CONTEXTE: Le risque d'événements cardiovasculaires indésirables et de mortalité associé au traitement de substitution de la testostérone est controversé. Le but du présent article est d'évaluer chez les hommes qui présentent un hypogonadisme secondaire l'effet du traitement de substitution de la testostérone (TST) sur le risque d'infarctus du myocarde (IM), d'accident cérébrovasculaire (ACV) ou de mortalité toutes causes confondues. PATIENTS ET MÉTHODES: Une étude de cohorte rétrospective a été menée en utilisant les dossiers de santé électroniques de la Clinique Cleveland. Ont été identifiés les hommes âgés de plus de 40 ans qui avaient au moins deux dosages de testostérone inférieurs à 220ng/dl, dont l'un obtenu le matin entre 7 et 10 heures. Ont été exclus les hommes qui présentaient un hypogonadisme primaire, un hypogonadisme secondaire lié à une pathologie hypothalamo-hypophysaire évidente, une infection par le virus de l'immunodéficience humaine, un cancer métastatique, et ceux qui présentaient des contrindications déterminées au TST. Les hommes exposés au TST ont été appariés à des témoins non exposés au TST. Une analyse de survie a été réalisée sur le paramètre composite incluant l'IM, l'AVC et la mortalité toutes causes confondues. RÉSULTATS: 165 patients exposés au TST (groupe traité) ont été appariés à 210 hommes non exposés au TST (groupe de référence). La prévalence de maladie cardiovasculaire (MCV) établie était de 20.0% dans le groupe traité versus 17.1% dans le groupe de référence (P=0.478). La médiane (écart interquartile (EI)) de l'âge et de l'indice de masse corporelle (IMC) était respectivement de 55 (49, 62) ans et de 35.6 (32.1, 40.1) kg/m2 dans le groupe traité, et respectivement de 55 (49, 61.7) ans et 36.3 (32.1, 40.8) kg/m2 dans le groupe de référence. Il y eut 12 événements indésirables (7.3%) dans le groupe traité, et 16 (7.6%) dans le groupe de référence. La médiane du temps (en années) des événements composites était de 2.1 (EI 0.9, 4.6) et de 1.8 (EI 0.6, 3.4) respectivement pour les groupes traité et de référence. Aucune différence n'a été observée en ce qui concerne le risque cardiovasculaire entre le groupe traité et le groupe de référence, rapport de risque (RR) 0.81 (Intervalle de Confiance à 95% [IC]: 0.38-1.71; P = 0.57). CONCLUSION: Chez les hommes qui présentent un hypogonadisme et une faible prévalence de maladie cardiovasculaire (MCV) établie, le TST n'apparait pas conférer un effet protecteur ou défavorable sur le risque de d'infarctus du myocarde (IM), d'accident cérébrovasculaire (ACV) ou de mortalité toutes causes confondues. MOTS-CLÉS: Traitement de substitution de la testostérone, Hypogonadisme masculin, Risque cardiovasculaire, Mortalité.

Individualized Metabolic Surgery Score: Procedure Selection Based on Diabetes Severity.

OBJECTIVE: To construct and validate a scoring system for evidence-based selection of bariatric and metabolic surgery procedures according to severity of type 2 diabetes (T2DM). BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM. METHODS: A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005-2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied. RESULTS: At median postoperative follow-up of 7 years (range 5-12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ≤25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional ß-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided. CONCLUSIONS: This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.

Who Should Get Extended Thromboprophylaxis After Bariatric Surgery?: A Risk Assessment Tool to Guide Indications for Post-discharge Pharmacoprophylaxis.

OBJECTIVE: To determine the risk factors for 30-day postdischarge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. BACKGROUND: VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. METHODS: From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to predict risk of postdischarge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (N = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. RESULTS: The overall 30-day incidence of postdischarge VTE was 0.29% (N = 269). In those experiencing a postdischarge VTE, mortality increased about 28-fold (2.60% vs 0.09%; P < 0.001). Among 45 examined variables, the final risk-assessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥60 years, male sex, BMI ≥50 kg/m, postoperative hospital stay ≥3 days, and operative time ≥3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted postdischarge VTE risk >1%. CONCLUSIONS: More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (ie, VTE risk >0.4%).

Primary Inadequate Weight Loss After Roux-en-Y Gastric Bypass Is not Associated with Poor Cardiovascular or Metabolic Outcomes: Experience from a Single Institution.

BACKGROUND: It is well accepted that bariatric surgery has cardiovascular and metabolic effects independent of weight loss. METHODS: Weight loss outcomes of patients undergoing Roux-en-Y gastric bypass (RYGB) at a high volume referral center were collected at 1 year postoperatively. Patients with failed primary weight loss were identified. Primary inadequate weight loss was defined as total body weight loss less than 15 %. Changes in hypertension (HTN), dyslipidemia, type 2 diabetes mellitus (T2DM), and metabolic syndrome profiles were investigated using Student's t test. RESULTS: A total of 2500 patients underwent RYGB from the years 2001-2013 at our institution. One hundred five (4.2 %) patients had primary inadequate weight loss. Within this cohort, 81 (77.1 %) patients had hypertension, 67 (63.8 %) had dyslipidemia, 53 (50.5 %) had type 2 diabetes mellitus, and 66 (62.9 %) patients had metabolic syndrome. At 1 year postoperatively, all metabolic parameters were significantly improved. Measures of metabolic disease included high-density lipoprotein (HDL) (46.3 ± 11.6 versus 54.1 ± 12.7 mg/dL, p < 0.01), low-density lipoprotein (LDL) (103.6 ± 35.8 versus 89.2 ± 30.0 mg/dL, p < 0.01), triglycerides (177.3 ± 139.1 versus 117.6 ± 59.3 mg/dL, p < 0.01), mean plasma glucose (128.9 ± 55.3 versus 102.7 ± 27.3 mg/dL, p < 0.01), and hemoglobin A1C (7.3 ± 1.9 versus 6.1 ± 1.0 %, p < 0.01). HTN was noted to improve in 27 (33.3 %) patients based on a decrease in the number of anti-hypertensives used (1.7 ± 1.0 versus 1.3 ± 1.3, p < 0.01), and 21 (31.8 %) patients had resolution of their metabolic syndrome. CONCLUSION: Improvement in cardiometabolic comorbidities still occurs despite suboptimal weight loss following RYGB.

A nationwide safety analysis of bariatric surgery in nonseverely obese patients with type 2 diabetes.

BACKGROUND: Bariatric surgery is more effective than medical therapy in treatment of type 2 diabetes (T2D) in patients with severe obesity. However, surgery is often not advocated for patients with T2D who are overweight or have mild obesity. OBJECTIVE: To assess the safety profile of bariatric surgery in patients with T2D and mild obesity. SETTING: Database of the American College of Surgeons-National Surgical Quality Improvement Program. METHODS: Data of 1300 patients with T2D and a body mass index≥25 but<35 kg/m(2) who underwent bariatric surgery were retrieved from the American College of Surgeons-National Surgical Quality Improvement Program data set (2005-2014) to assess safety profile. Further stratified analyses were carried out between Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). RESULTS: The mean operative time and length of hospital stay were 109.4±58.3 minutes and 1.9±1.5 days, respectively. Incidence of all individual major complications was≤.5% in this cohort except for postoperative bleeding (1.7%). Thirty-day postoperative composite morbidity, serious morbidity, and mortality rates for total cohort were 4.2%, .7%, and .15%, respectively. Smoking (odds ratio = 2.75, 95% confidence interval: 1.34-5.64) and chronic obstructive pulmonary disease (odds ratio = 4.05, 95% confidence interval: 1.51-10.88) were predictors of composite morbidity. Thirty-day morbidity rates were not significantly different between those who underwent RYGB compared with SG. CONCLUSION: Bariatric surgery, which is a 2-hour procedure requiring a 2-day hospital stay, is a relatively well-tolerated option in patients with T2D and mild obesity. RYGB and SG had comparable early postoperative morbidity. Smoking can be considered as a modifiable risk factor for early complications after bariatric surgery in patients with T2D and lower body mass index.

Bariatric Surgery in Obese Patients With Type 1 Diabetes.

OBJECTIVE: There is a paucity of data on the impact of bariatric surgery in type 1 diabetes (T1D). The aim of this review was to quantify the overall effects of bariatric surgery in obese patients with T1D. METHODS: We searched PubMed, Scopus, ISI Web of Knowledge, and Google Scholar from their inception to December 2015 to identify all relevant studies of bariatric surgery in adult obese patients with T1D. RESULTS: The review included 17 studies with 107 individuals, including 10 case series and 7 case reports. Overall, the dominant procedure was gastric bypass (n = 70; 65%). All studies reported a significant reduction in excess weight. A significant reduction in weight-adjusted daily insulin requirements was shown in all case series except one. Pooled mean ± SD of pre- and postoperative glycated hemoglobin (HbA1c) for the entire cohort with available data (n = 96) was 8.4 ± 1.3% and 7.9 ± 1.1%, respectively (P = 0.01). In addition to common postoperative complications, profound glycemic changes (diabetic ketoacidosis and hypoglycemia) and gastrointestinal dysmotility symptoms (prolonged ileus and acute gastric remnant dilation) have been reported. No surgical mortality was reported. CONCLUSIONS: Bariatric surgery leads to significant weight loss in severely obese patients with T1D and results in a significant improvement in insulin requirements and glycemic status. The favorable metabolic effects of bariatric surgery may facilitate medical management of and cardiovascular risk reduction in T1D in the setting of severe obesity. Diabetic ketoacidosis and hypoglycemia are potentially serious complications. Short-term results of bariatric surgery in patients with T1D are encouraging, but larger and longer-term studies are needed.

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial.

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (-11.3% versus -1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was -29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24.

Outcomes of bariatric surgery in type 2 diabetic patients with diminished pancreatic secretory reserve.

Although the marked and durable effects of bariatric surgery on early type 2 diabetes is known, there are limited data on the impact of surgery in patients with reduced beta-cell function/reserve. Clinical outcomes of 15 morbidly obese patients with poorly controlled diabetes who underwent bariatric surgery in a 10-year period and had a baseline fasting serum c-peptide ≤0.5 ng/mL were assessed. All patients had glycated hemoglobin >7 % and were on insulin before surgery. Surgical procedures included laparoscopic gastric bypass (n = 9), sleeve (n = 5), and banding (n = 1) without any intraoperative complications. At a mean follow-up of 39.6 ± 22.9 months, a mean reduction in body mass index of 25.1 ± 9.2 % and a mean percent excess weight loss of 61.5 ± 19.7 % were associated with a significant improvement in daily insulin requirement and lipid profile. At the last follow-up point, three patients (20 %) were off insulin, five patients (33.3 %) had a glycated hemoglobin ≤7 %, and one patient (6.7 %) had remission of diabetes. Hypertension resolved or improved in 5 of 11 (45.5 %) hypertensive patients. In conclusion, bariatric surgery can result in improvement of glycemic status and comorbid conditions of obese diabetic patients with diminished beta-cell reserve and may facilitate medical management of diabetes.

How can we predict which morbidly obese patients will adhere to weight-loss programs based on life style changes?

INTRODUCTION: Dropout is a highly prevalent and serious problem in assessing the effectiveness of weight loss studies and a major cause of treatment failure in the management of morbidly obese patients. OBJECTIVES: To determine which tests used for the psychometric evaluation of morbidly obese patients are more predictive of success/dropout in a weight loss program. METHODS: Sixty patients aged 18-65 attending the Outpatient Obesity Clinic between 2009 and 2011, were recruited for an intensive life style weight loss program. We compared the results obtained in Hamilton Depression scale, Hamilton Anxiety scale, Golombok Rust Inventory of Sexual Satisfaction, Eating Disorders Inventory-2, SF-36 Health Survey and Plutchik's Impulsivity questionnaire between patients who completed the intervention with those obtained in patients who did not complete it. RESULTS: The rate of decline in the patients attending our program was 41.6% in the first year. Our results suggest that the Plutchik Impulsivity questionnaire, could be used as a predictive tool for success/attrition in intensive life style weight loss program. CONCLUSIONS: Our results suggest that the Plutchik Impulsivity questionnaire, could be used as a predictive tool for success/attrition in intensive life style weight loss program. The screening of patients prior to inclusion in these programs should help to optimize its efficacy and efficiency.

Weight-related quality of life in Spanish obese subjects suitable for bariatric surgery is lower than in their North American counterparts: a case-control study.

BACKGROUND: Obesity impairs quality of life, but the perception of the impairment could be different from one country to another. The purpose was to compare weight-related quality of life (QOL) between cohorts from Spain and North America. METHODS: A cross-sectional case-control study was performed between two populations. Four hundred Spanish and 400 North American obese subjects suitable for bariatric surgery closely matched for race, gender, age, and body mass index (BMI) were included. Two non-obese control groups matched for gender, age, and BMI from each population were also evaluated (n = 400 in each group). The participants completed the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a measure of weight-related QOL. RESULTS: Spanish morbidly obese patients showed poorer QOL than their North American counterparts in physical function, sexual life, work, and total score. By contrast, Spanish non-obese control subjects reported better QOL in all domains than their North American counterparts. Women, both in Spain and North America, reported reduced QOL compared to men on the domain of self-esteem. In addition, North American women reported reduced QOL on the sexual life domain compared to men. BMI correlated negatively with all domains of QOL except for self-esteem in both national groups. CONCLUSIONS: Spanish obese subjects suitable for bariatric surgery report poorer weight-related quality of life than their North American counterparts, and obese women, regardless of nationality, perceive a reduced quality of life compared to men.

One year weight loss in the TRAMOMTANA study. A randomized controlled trial.

BACKGROUND: Morbid obesity is a major health problem and bariatric surgery is currently the most effective therapy available to induce weight loss in these patients. This report describes 1-year changes in weight and metabolic parameters, in a trial designed to examine the effects of a nonsurgical approach, Intensive Life style Intervention (ILI) on the therapy of morbid obesity. METHODS: The primary outcome was change in body weight. Patients were randomized to ILI (n = 60) or conventional obesity therapy (COT) (n = 46). The ILI group received behavioural therapy and nutritional/physical activity counselling. The COT group received the standard medical treatment available for these patients. A third group consisted of the patients already included in our bariatric surgery waiting list (n = 37). FINDINGS: We present here 1-year data showing that patients who received ILI with no restrictions in calorie intake had a greater percentage of weight loss than patients receiving COT (-11·58% vs -0·4%; P < 0·001). Importantly, 31·4% of patients included in the ILI group were not morbidly obese after 6 months of intervention. This number increased to 42·8% after 12 months of intervention. INTERPRETATION: ILI was associated with significant weight loss compared with COT in a group of morbidly obese patients. The weight loss effect was already obtained after 6 months of ILI intervention. These results seriously question the efficacy of the COT approach to morbid obesity. Furthermore, they underscore the use of ILI programmes in the hospital setting to effectively treat morbidly obese patients and might help to reduce the number of candidate patients for bariatric surgery.