Short-term effects of gastric bypass versus sleeve gastrectomy on high LDL cholesterol: The BASALTO randomized clinical trial.

BACKGROUND: There has been a substantial increase in the use of laparoscopic sleeve gastrectomy (SG) to treat morbid obesity despite observational evidence demonstrating the superiority of Roux-en-Y gastric bypass (RYGB) for reducing low-density lipoprotein (LDL) cholesterol. The main aim was to ascertain whether high LDL cholesterol levels should be considered when selecting the most appropriate surgical procedure for each patient (RYGB or SG). METHODS: In this single-center, randomized clinical trial using intention-to-treat analysis, 38 patients with severe obesity and elevated levels of LDL cholesterol were randomly assigned to undergo RYGB or SG. The primary outcome was LDL cholesterol remission at 12 months, defined as LDL cholesterol < 3.36 nmol/l without lipid-lowering medications. Secondary outcomes included changes in weight, other comorbidities, qualitative lipoprotein traits, cholesterol esters, glycoproteins, cholesterol absorption and synthesis metabolites and complications. RESULTS: Intention-to-treat analysis revealed that LDL cholesterol remission occurred in 66.6% of RYGB patients compared to 27.8% of SG patients (p = 0.019). Among patients completing follow-up, RYGB demonstrated superior remission (80.0% vs. 29.4%, p = 0.005). Exclusive benefits of RYGB included a reduction in large, medium, and small LDL particles. Cholesterol absorption markers showed differential behavior after both techniques: campesterol (Δ -15.2 µg/mg, 95% CI -30.2 to -0.1) decreased after RYGB, and sitosterol (Δ 21.1 µg/mg, 95% CI 0.9 to 41.2), cholestanol (Δ 30.6 µg/mg, 95% CI 14.8 to 57.9) and campesterol (Δ 18.4 µg/mg, 95% CI 4.4 to 32.3) increased after SG. No differences in weight loss, cholesterol esters, glycoproteins, cholesterol synthesis metabolites or postoperative complications were observed between techniques. CONCLUSION: In conclusion, RYGB is superior to SG in terms of short-term of high LDL cholesterol remission. Furthermore, RYGB also led to a greater improvement in lipoprotein parameters that confer an atherogenic profile. Therefore, the presence of elevated levels of LDL cholesterol should be considered when determining the optimal bariatric surgery procedure for each patient. TRIAL REGISTRATION: Clinicaltrials.gov number, NCT03975478).

Use of phytosterol-fortified foods to improve LDL cholesterol levels: A systematic review and meta-analysis.

AIMS: The main objective was to assess if foods fortified with phytosterols (PS), including plant sterols and plant stanols, reduce low-density lipoprotein cholesterol (LDL-C) concentrations. The secondary objective was to determine the impact of different factors related to PS administration. DATA SYNTHESIS: The search was carried out in MEDLINE, EMBASE, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials (CENTRAL) databases up to March 2023. The meta-analysis was registered in the PROSPERO database (CRD42021236952). From a total of 223 studies, 125 were included. On average, PS lowered LDL-C 0.55 mmol/L [95% confidence interval (CI) = 10.82-12.67], and this decrease was significantly maintained for all analysed subgroups. A greater reduction in LDL-C levels was detected in relation to a higher daily PS dosage. The food format "Bread, biscuits, cereals", conditioned a lower decrease of 0.14 mmol/L (95%CI -8.71 to -2.16) in LDL-C levels, compared to the predominant food format group of "butter, margarine, spreads". No significant differences were detected with the other subgroups (treatment duration, intake pattern, number of daily intakes and concomitant statin treatment). CONCLUSION: The present meta-analysis supported that the use of PS-fortified foods had a beneficial effect on LDL-C lowering. In addition, it was observed that the factors that influence a decline LDL-C levels were PS dose as well as the food format in which they were consumed.

Level of understanding and consumption of ultra-processed food in a Mediterranean population: A cross-sectional study.

BACKGROUND AND AIMS: Since the population may not be aware of ultra-processed food (UPF) consumption as a result of ignorance or non-recognition, this study aimed to ascertain the main characteristics of subjects regarding their knowledge of different easily acquired foods through a questionnaire in Google Forms format with 52 questions. Secondary objectives were to determine whether the profile of UPF consumers can be defined based on sex, age, sociodemographic factors, and lifestyle. METHODS AND RESULTS: Responses were received from 1037 participants from a convenience sample; of these, 83 (8.0%) were sporadic or non-users, and 954 (92.0%) were frequent UPF consumers. The participants of the upper tertile correctly matched >12 food items, those of the medium tertile matched 12-9 items, and those of the lower tertile matched <9 items. Factors independently associated with participants who better identified UPF (upper tertile) compared to those of the lower tertile (reference) were female sex (OR: 2.54, 95%CI: 1.70-3.79; p < 0.001), age between 21 and 50 (OR: 3.63, 95% CI: 2.56-5.15; p < 0.001), living with family (OR: 0.64, 95% CI: 0.41-9.96; p = 0.033), and eating more fruit (≥3 pieces/day, OR: 2.30, 95% CI: 1.61-3.27; p < 0.001). CONCLUSIONS: These findings highlight the high consumption and low degree of awareness of UPF among consumers based mainly on food composition.

Trends in prevalence of gestational diabetes and perinatal outcomes in Catalonia, Spain, 2006 to 2015: the Diagestcat Study.

BACKGROUND: No recent epidemiologic studies on gestational diabetes mellitus (GDM) have been conducted in Spain. The present study aimed to explore trends in the prevalence of GDM and ascertain whether the risk of adverse perinatal outcomes changed between 2006 and 2015 in Catalonia. METHODS: In this population-based study, all hospital admissions for singleton births in Catalonia for the period 2006 to 2015 were collected from the Spanish Minimum Basic Data Set. Cases of GDM were identified from hospital delivery discharge reports using ICD-9-CM codes. Data regarding maternal characteristics and perinatal outcomes were analysed. Crude and age-adjusted annual prevalences were calculated. The Poisson regression model was used to assess trends in prevalence and perinatal outcomes, adjusted for age and smoking habit; however, they could not be adjusted for body mass index (BMI) and ethnicity. RESULTS: Data from 743 762 deliveries were collected. GDM prevalence over the study period was 4.80% (95% CI 4.75-4.85%). Crude GDM prevalence rose from 3.81% (95% CI 3.67-3.95%) in 2006 to 6.53% (95% CI 6.33-6.72%) in 2015 (P < 0.001). Women with GDM showed a stable trend in rates of preeclampsia (2.56%), prematurity (15.7%), and large-for-gestational age (LGA) newborns (18.3%), whereas a lower rate of macrosomia was observed during the study period (from 9.16% to 7.84%). Caesarean deliveries rose from 28% to 31%; however, significance was lost after adjustment. CONCLUSIONS: The prevalence of GDM in Catalonia almost doubled between 2006 and 2015. During the study period, the frequency of macrosomia decreased whereas pre-eclampsia, prematurity, LGA, and age-adjusted Caesarean rates remained stable.

Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy.

BACKGROUND: Clinical guidelines recommend either a clear-liquid diet or a low-fiber diet for colonoscopy preparation. Participants in a screening program are usually motivated healthy individuals in which a good tolerability is important to improve adherence to potential surveillance colonoscopies. OBJECTIVE: Our aim was to assess whether or not a normocaloric low-fiber diet followed the day before a screening colonoscopy compromises the efficacy of bowel cleansing and may improve the tolerability of bowel preparation. DESIGN: This is a randomized, endoscopist-blinded, noninferiority clinical trial. SETTINGS: The study was conducted at a tertiary care center. PATIENTS: A total of 276 consecutive participants of the Barcelona colorectal cancer screening program were included. INTERVENTION: Participants were randomly assigned to a clear-liquid diet or a normocaloric low-fiber diet the day before the colonoscopy. Both groups received 4 L of polyethylene glycol in a split-dose regimen. MAIN OUTCOME MEASURES: Primary outcome was the adequate bowel preparation rate measured with the Boston bowel preparation scale. Secondary outcomes included tolerability, fluid-intake perception, hunger, side effects, and acceptability. RESULTS: Participants in both groups were similar in baseline characteristics. Adequate bowel preparation was achieved in 89.1% vs 95.7% in clear-liquid diet and low-fiber diet groups, showing not only noninferiority, but also superiority (p = 0.04). Low-fiber diet participants reported less fluid-intake perception (p = 0.04) and less hunger (p = 0.006), with no differences in bloating or nausea. LIMITATIONS: The single-center design of the study could limit the external validity of the results. The present findings may not be comparable to other clinical settings. CONCLUSION: A normocaloric low-fiber diet the day before a screening colonoscopy achieved better results than a clear-liquid diet in terms of adequate colon preparation. Moreover, it also improved the perception of hunger and excessive fluid intake. Registered at clinicaltrials.gov: NCT02401802. See Video Abstract at http://links.lww.com/DCR/A829.

Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial.

Background and study aims: Previous studies have reported that diabetes mellitus is an independent risk factor for inadequate bowel preparation. Current guidelines do not recommend a specific preparation for this patient population. The aims of this study were to assess the efficacy, safety, and tolerability of an adapted preparation protocol for colon cleansing in patients with type 2 diabetes mellitus. Patients and methods: This randomized, single-blind, parallel group, superiority trial compared a conventional bowel preparation protocol (CBP) with a diabetes-specific preparation protocol (DSP). The CBP included a low-fiber diet for 3 days followed by a clear liquid diet for 24 hours before colonoscopy. The DSP included a multifactorial strategy combining an educational intervention, a low-fiber diet, and adjustment of blood glucose-lowering agents. All patients received 4 L of a polyethylene glycol solution in a split-dose regimen. The endoscopists were blinded to the preparation protocol. The primary outcome measure was inadequate bowel preparation according to the Boston Bowel Preparation Scale. Secondary outcome measures included hypoglycemic events, tolerability, and acceptability. Results: A total of 150 patients were included in the study (74 CBP and 76 DSP). Both groups were comparable in terms of baseline characteristics. Inadequate bowel cleansing was more frequent following CBP than DSP (20 % vs. 7 %, P = 0.014; risk ratio 3.1, 95 % confidence interval 1.2 - 8). Only CBP and performance status were independently associated with inadequate bowel preparation. Both preparations were equally tolerated and accepted by patients, and side-effects were similar between the groups. Conclusions: A multifactorial strategy for bowel preparation in patients with diabetes undergoing colonoscopy showed a threefold reduction in the rate of inadequate bowel preparation, with no differences in safety and tolerability compared with conventional preparation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02300779).

Testosterone undecanoate improves lipid profile in patients with type 1 diabetes and hypogonadotrophic hypogonadism.

Testosterone deficiency (Td) has been associated with the metabolic syndrome. Few studies have evaluated this condition in type 1 diabetes (T1D). The primary aim of this study was to evaluate the effectiveness of testosterone undecanoate (TU) on insulin sensitivity, glycemic control, anthropometric parameters, blood pressure and lipid profile in patients with Td and T1D. We performed a randomized placebo-controlled multicenter study. INCLUSION CRITERIA: a) age ≥ 18 years; b) autoimmune diabetes; c) Td (total testosterone <10 nmol/L or calculated free testosterone <225 pmol/L and low/normal LH; d) ability to sign informed consent; e) comply with the study protocol. EXCLUSION CRITERIA: a) pituitary tumor, empty sella, hyperprolactinemia, panhypopituitarism or secondary hypogonadism; b) contraindications for treatment with testosterone undecanoate (TU); c) patients who did not agree to sign their informed consent. Six patients were randomly assigned to testosterone undecanoate (TU) treatment and 7 to placebo with the following dosing schedule: baseline, 6 weeks and 16 weeks. Blood test, anthropometric parameters, blood pressure and insulin sensitivity were determined at baseline, 6, 16 and 22 weeks. No differences were observed regarding insulin sensitivity, HbA1c or basal glucose, anthropometric parameters or blood pressure. At 22 weeks, the decrease in total cholesterol was 37.4 ± 27.5 mg/dL in the TU group compared with an increase of 13.2 ± 17.8 mg/dL in the placebo group (P<0.005), and LDL cholesterol concentration decreased 30.2 ± 22.1 mg/dL, compared with an increase of 10.5 ± 13.4 mg/dL in the placebo group (P=0.004). We conclude that treatment with TU in patients with T1D and Td improves lipid profile, with no effects on metabolic control or anthropometric parameters.

Age, insulin requirements, waist circumference, and triglycerides predict hypogonadotropic hypogonadism in patients with type 1 diabetes.

INTRODUCTION: The prevalence of hypogonadotropic hypogonadism (HH) in patients with type 2 diabetes mellitus is higher than in the general population and leads to detrimental effects on metabolic control, lipid profile, and body composition. Few studies have examined its role in type 1 diabetes mellitus. AIM: To determine the prevalence of HH in patients with type 1 diabetes and associated risk factors. MAIN OUTCOME MEASURES: Clinical and biochemical parameters were gathered on initial evaluation. An HH score creating different experimental models was devised to calculate the risk of HH for an individual with type 1 diabetes. METHODS: Cross-sectional study of 181 male patients with type 1 diabetes consecutively admitted to the Diabetes outpatient clinics of three urban hospitals. All participants were Caucasians aged ≥ 18 years with type 1 diabetes duration of more than 6 months. RESULTS: One hundred and eighty-one male patients with a mean age of 44.2 ± 13.2 years and a type 1 diabetes duration of 18.9 ± 12.7 years were included. Fifteen patients had HH, representing a prevalence of 8.3% (95% confidence interval [CI]: 4.3-12.3%). Age (odds ratio [OR] 1.066 [95% CI: 1.002-1.134]), waist circumference (OR 1.112 [95% CI: 1028-1203]), and insulin requirements ([IU/Kg] ×10 [OR 1.486 {95% CI: 1052-2.098}]) were independently associated with the presence of HH. The model that best predicted HH generated this formula: HH-score = (1.060 × age) + (1.084 × waist circumference) + (14.00 × insulin requirements) + triglycerides, where age was expressed in years, waist circumference in cm, insulin requirements in IU/kg/d, and triglycerides in mg/dL. An HH score > 242.4 showed 100% sensitivity and 53.2% specificity for HH diagnosis; positive and negative predictive values were 17.0 % and 100%, respectively. CONCLUSIONS: One in 10 men with type 1 diabetes presents HH. This condition is associated with age, waist circumference, and insulin requirements. A simple formula based on clinical parameters can rule out its presence.

Effects of Preoperative Quadruple Therapy for Helicobacter pylori on Bariatric Surgery Metabolic Outcomes.

PURPOSE: To assess the effects of Helicobacter pylori (HP) eradication with an omeprazole, clarithromycin, amoxicillin, and metronidazole (OCAM) regimen on the metabolic profile and weight loss 12 months after bariatric surgery (BS). METHODS: Retrospective analysis of a prospective cohort of patients with morbid obesity undergoing BS. HP presence was tested preoperatively by gastric biopsy and treated with OCAM when positive. Short-term metabolic outcomes and weight loss were evaluated. RESULTS: HP infection was detected in 75 (45.7%) of the 164 patients included. OCAM effectiveness was 90.1%. HP-negative patients had a greater reduction in glucose levels at 3 (-14.6 ± 27.5 mg/dL HP-treated vs -22.0 ± 37.1 mg/dL HP-negative, p=0.045) and 6 months (-13.7 ± 29.4 mg/dL HP-treated vs -26.4 ± 42.6 mg/dL HP-negative, p= 0.021) and greater total weight loss (%TWL) at 6 (28.7 ± 6.7% HP-treated vs 30.45 ± 6.48% HP-negative, p= 0.04) and 12 months (32.21 ± 8.11% HP-treated vs 35.14 ± 8.63% HP-negative, p= 0.023). CONCLUSIONS: Preoperative treatment with OCAM has been associated to poorer glycemic and weight loss outcomes after BS. More research is needed on the influence of OCAM on gut microbiota, and in turn, the effect of the latter on metabolic and weight loss outcomes after BS.

Ethnic differences in the impact of gestational diabetes on macrosomia.

BACKGROUND: Previous studies reported an ethnic disparity in gestational diabetes mellitus-associated birth outcomes, with some suggesting that macrosomia increases to a lesser extent in groups at high risk, the opposite of the pattern observed by others. Our aim was to evaluate ethnic variation in the impact of gestational diabetes mellitus (GDM). METHODS: A case-control study evaluating pregnancy outcomes was conducted in women with and without GDM from five ethnic groups. Data on GDM were collected between January 2004 and July 2017. Women giving birth between May 2013 and July 2017 in whom pre-existing diabetes had been ruled out served as controls. A multivariate logistic regression analysis was performed to determine factors independently associated with macrosomia. RESULTS: Overall, 852 GDM women and 3,803 controls were included. In Caucasian and East-Asian women excessive gestational weight gain (OR 2.273, 95% CI 1.364-3.788 and OR 3.776, 95% CI 0.958-14.886) was an independent predictor of macrosomia. In Latin-American and Moroccan women, obesity (OR 1.774, 95% CI 1.219-2.581 and OR 1.656, 95% CI 1.054-2.601), GDM (OR 2.440; 95% CI 1.048-5.679 and OR 3.249, 95% CI 1.269-8.321) and gestational weight gain but only for Latin-American women (OR 2.365, 95% CI 1.039-5.384) were associated with macrosomia. In South-Central Asian women, only GDM was associated with macrosomia (OR 3.701, 95% CI 1.437-9.532). CONCLUSIONS: GDM is an independent predictor of macrosomia in Latin-American, South-Central Asian and Moroccan women but not in Caucasian or East-Asian women in whom other factors play a more important role.

Acute-to-Chronic Glycemic Ratio as a Predictor of COVID-19 Severity and Mortality.

OBJECTIVE: To evaluate the association between acute-to-chronic (A/C) glycemic ratio and mortality and severity outcomes for patients with type 2 diabetes (T2D) hospitalized with coronavirus disease 2019 (COVID-19). RESEARCH DESIGN AND METHODS: A total of 91 patients were included. We measured glycemia at admission and estimated the average chronic glucose levels to calculate the A/C glycemic ratio. The primary outcome was a composite of in-hospital mortality, intensive care unit admission, and mechanical ventilation. RESULTS: Thirty-five patients had a primary outcome event, presenting a significant association with the A/C glycemic ratio (hazard ratio [HR] 1.57 [95% CI 1.14-2.15], P = 0.005). In comparisons with the 2nd tertile, the 3rd tertile of the A/C glycemic ratio was associated with the primary outcome (HR 3.39 [95% CI 1.31-8.75], P = 0.012). In the multivariate analysis, after additional adjustment for age, sex, comorbidities, inflammatory markers, and corticosteroid therapy, the association for the 3rd tertile (HR 3.96 [95% CI 1.35-11.59], P = 0.012) remained significant. CONCLUSIONS: In patients with T2D hospitalized with COVID-19, the imbalance between acute glycemia at admission and chronic metabolic control is associated with worse prognosis.

Seven-year mortality in heart failure patients with undiagnosed diabetes: an observational study.

BACKGROUND: Patients with type 2 diabetes mellitus and heart failure have adverse clinical outcomes, but the characteristics and prognosis of those with undiagnosed diabetes in this setting has not been established. METHODS: In total, 400 patients admitted consecutively with acute heart failure were grouped in three glycaemic categories: no diabetes, clinical diabetes (previously reported or with hypoglycaemic treatment) and undiagnosed diabetes. The latter was defined by the presence of at least two measurements of fasting plasma glycaemia ≥ 7 mmol/L before or after the acute episode.Group differences were tested by proportional hazards models in all-cause and cardiovascular mortality during a 7-year follow-up. RESULTS: There were 188 (47%) patients without diabetes, 149 (37%) with clinical diabetes and 63 (16%) with undiagnosed diabetes. Patients with undiagnosed diabetes had a lower prevalence of hypertension, dyslipidaemia, peripheral vascular disease and previous myocardial infarction than those with clinical diabetes and similar to that of those without diabetes. The adjusted hazards ratios for 7-year total and cardiovascular mortality compared with the group of subjects without diabetes were 1.69 (95% CI: 1.17-2.46) and 2.45 (95% CI: 1.58-3.81) for those with undiagnosed diabetes, and 1.48 (95% CI: 1.10-1.99) and 2.01 (95% CI: 1.40-2.89) for those with clinical diabetes. CONCLUSIONS: Undiagnosed diabetes is common in patients requiring hospitalization for acute heart failure. Patients with undiagnosed diabetes, despite having a lower cardiovascular risk profile than those with clinical diabetes, show a similar increased mortality.

Bariatric surgery improves metabolic and nonalcoholic fatty liver disease markers in metabolically healthy patients with morbid obesity at 5 years.

BACKGROUND: No studies have evaluated the effect of metabolic and bariatric surgery (MBS) on nonalcoholic fatty liver disease (NAFLD) and cardiometabolic markers in metabolically healthy patients with morbid obesity (MHMO) at midterm. OBJECTIVES: To assess the effect of MBS on NAFLD and cardiometabolic markers in MHMO patients and ascertain whether metabolically unhealthy patients with morbid obesity (MUMO) remain metabolically healthy at 5 years after MBS. SETTING: University hospital. METHODS: A total of 191 patients with a body mass index >40 kg/m2 and at least 5 years of follow-up were retrospectively analyzed. Lost to follow-up were 37.6% (151 of 401 patients). Patients were classified as MHMO if 1 or 0 of the cardiometabolic markers were present using the Wildman criteria. The degree of liver fibrosis was assessed using the NAFLD fibrosis score (NFS). RESULTS: Forty-one patients (21.5%) fulfilled the criteria for MHMO. They showed significant improvements in blood pressure (from 135.1 ± 22.1 and 84.2 ± 14.3 mm Hg to 117.7 ± 19.2 and 73.0 ± 10.9 mm Hg), plasma glucose (from 91.0 ± 5.6 mg/dL to 87.2 ± 5.2 mg/dL), homeostatic model assessment for insulin resistance (from 2.2 ± .9 to 1.0 ± .8), triglycerides (from 88.0 [range, 79.5-103.5] mg/dL to 61.0 [range, 2.0-76.5] mg/dL), alanine aminotransferase, gamma-glutamyl transpeptidase NFS (from -1.0 ± 1.0 to -1.9 ± 1.2), and high-density lipoprotein cholesterol (from 56.9 ± 10.5 mg/dL to 77.9 ± 17.4 mg/dL) at 5 years after surgery. A total of 108 MUMO patients (84.4%) who became metabolically healthy after 1 year stayed healthy at 5 years. CONCLUSIONS: MBS induced a midterm improvement in cardiometabolic and NAFLD markers in MHMO patients. Seventy-six percent of MUMO patients became metabolically healthy at 5 years after MBS.

Peripartum metabolic control in gestational diabetes.

OBJECTIVE: We sought to evaluate intrapartum metabolic control in gestational diabetes mellitus (GDM) patients and maternal factors influencing intrapartum glycemic control and neonatal hypoglycemia risk. STUDY DESIGN: A prospective observational study included 129 women with GDM admitted for delivery. Data collected included maternal intrapartum capillary blood glucose (CBG) and ketonemia, use of insulin, and neonatal hypoglycemia. RESULTS: In all, 86% of maternal intrapartum CBG values fell within target range (3.3-7.2 mmol/L) without need for insulin use. There were no cases of maternal hypoglycemia or severe ketosis. Intrapartum CBG >7.2 mmol/L was associated with third-trimester glycated hemoglobin (P = .02) and lack of endocrinologic follow-up (P = .04). Risk of neonatal hypoglycemia was related with pregnancy insulin use compared with dietary control (60.5% vs 29.5%; P = .02). CONCLUSION: Peripartum metabolic control in GDM patients was achieved without insulin in most cases. Intrapartum glycemic control was related with third-trimester glycated hemoglobin and with no endocrinologic follow-up. Neonatal hypoglycemia was associated with insulin use during pregnancy.

Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol.

INTRODUCTION: Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgical procedure election. Furthermore, it is also necessary to establish the mechanisms by which LDL cholesterol improves after surgery and whether qualitative and quantitative changes occur in the different lipoprotein subclasses. The first objective is to ascertain whether high LDL cholesterol levels before surgery can be considered an additional factor when selecting the most appropriate surgical procedure for each patient (gastric bypass or sleeve gastrectomy). Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared. Secondary objectives were (1) to compare changes in other lipoproteins and LDL composition and (2) to study the pathophysiologic mechanisms related to LDL cholesterol remission. METHODS AND ANALYSIS: A randomised clinical trial, with intention-to-treat analysis, will be conducted to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy, with a 12-month follow-up. Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40 kg/m2 or ≥35 kg/m2 with significant obesity-related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Parc de Salut Mar Ethics Committee (2019/8471/I). The study and its conclusions regarding the primary and secondary objectives will be presented as manuscripts submitted for peer-reviewed journal publication. TRIAL REGISTRATION NUMBER: NCT03975478.

Additional Metabolic Effects of Bariatric Surgery in Patients with a Poor Mid-Term Weight Loss Response: A 5-Year Follow-Up Study.

To ascertain the 5-year metabolic effects of bariatric surgery in poor weight loss (WL) responders and establish associated factors. METHODS: Retrospective analysis of a non-randomised prospective cohort of bariatric surgery patients completing a 5-year follow-up. Mid-term poor WL was considered when 5-year excess weight loss was <50%. RESULTS: Forty-three (20.3%) of the 212 included patients were mid-term poor WL responders. They showed an improvement in all metabolic markers at 2 years, except for total cholesterol. This improvement with respect to baseline was maintained at 5 years for plasma glucose, HbA1c, HOMA, HDL and diastolic blood pressure; however, LDL cholesterol, triglycerides and systolic blood pressure were similar to presurgical values. Comorbidity remission rates were comparable to those obtained in the good WL group except for hypercholesterolaemia (45.8% vs. poor WL, p = 0.005). On multivariate analysis, lower baseline HDL cholesterol levels, advanced age and lower preoperative weight loss were independently associated with poor mid-term WL. CONCLUSIONS: Although that 1 in 5 patients presented suboptimal WL 5 years after bariatric surgery, other important metabolic benefits were maintained.

Most of qualitative dietary changes observed one year post-bariatric surgery can be achieved with a preoperative dietary intervention.

BACKGROUND AND OBJECTIVES: Bariatric surgery (BS) leads to several changes in nutritional habits that can be attributed to different mechanisms. Some of these changes could be achievable with a preoperative nutritional intervention. The objective was to evaluate dietary modifications during the preoperative and postoperative periods of BS. METHODS: Prospective observational study of patients who underwent BS between 2010 and 2014 at the Hospital del Mar; 60 consecutive patients were included. Food consumption was measured by a validated food-frequency questionnaire at inclusion in the bariatric surgery program, after preoperative nutritional intervention, and one year after surgery. Generalized estimating equation models were used to assess differences in food group intake during follow up. RESULTS: Energy intake significantly decreased from inclusion to 1 year of surgery (p=0.003). After the preoperative intervention and prior to surgery, there was an increase in intake of nuts, vegetables, poultry and rabbit, fruit, fish and skimmed milk products and a decrease in bread, soft drinks and pastry. At one year post-surgery, a continued decrease in the consumption of bread and soft drinks and an increase in nuts was observed (linear non-quadratic trend). Consumption of fruit, pastry, fish and skimmed milk products remained stable showing a linear and quadratic trend. Vegetables and poultry and rabbit increased in the preoperative period and decreased after surgery, showing a quadratic but not linear trend. CONCLUSIONS: a preoperative nutritional intervention in morbidly obese patients can associate favorable dietary changes that are mostly maintained one year after bariatric surgery.

Gestational diabetes mellitus in a multiethnic population in Spain: Incidence and factors associated to impaired glucose tolerance one year after delivery. / Incidencia y factores asociados al metabolismo alterado de la glucosa un año después del parto en una población multiétnica de mujeres con diabetes mellitus gestacional en España.

BACKGROUND AND AIM: Women with history of gestational diabetes mellitus (GDM) are at increased risk for diabetes. Ethnicity may modify such risk, but no studies have been conducted in our environment. The aim of this study was to assess the incidence of type 2 diabetes mellitus and prediabetes one year after delivery in women with GDM and in a multiethnic background and to identify the associated factors. PATIENTS AND METHODS: A retrospective analysis of a prospective, observational cohort of women with GDM who attended annual postpartum follow-up visits at Hospital del Mar from January 2004 to March 2016. RESULTS: Three hundred and five women attended postpartum follow-up visits. Of these, 47.2% were Caucasian, 22% from South-Central Asia, 12% from Latin America, and 10% from Morocco and East Asia. Incidence rates of type 2 diabetes mellitus and prediabetes in these patients were 5.2 and 36.6%, respectively. In a multivariate analysis, non-Caucasian origin (OR=3.15, 95% CI [1.85-5.39]), recurrent gestational diabetes (OR=2.26, 95% CI [1.11-4.59]), and pre-pregnancy body mass index (OR=1.09, 95% CI [1.04-1.15]) were independent predictors of impaired glucose tolerance. CONCLUSIONS: In a multiethnic Spanish population of women with GDM, incidence of impaired glucose tolerance in the first year after delivery was 41.8%, with a three-fold increased risk for women of non-Caucasian ethnicity.

Changes in Thyroid Replacement Therapy after Bariatric Surgery: Differences between Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Sleeve Gastrectomy.

INTRODUCTION: Levothyroxine (LT4) requirements can presumably be modified differently after laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). The present study compared changes in LT4 dose in hypothyroid subjects undergoing LRYGB or LSG 2 years after the procedure. MATERIAL AND METHODS: A 2-year follow-up observational study was conducted in a prospective cohort of obese patients who had undergone bariatric surgery and were receiving LT4. Indication for the type of surgical procedure was based on clinical criteria. Repeated measures ANOVA models were used to examine differences within and between groups. RESULTS: Thirty-five consecutive patients were included for analysis: 22 LRYGB and 13 LSG. Total daily LT4 dosage decreased in the LSG group (133.7 ± 50.3 mcg/day at baseline to 104.3 ± 43.3 mcg/day at 2 years; p = 0.047) whereas it remained stable in the LRYGB group (129.5 ± 46.1 mcg/day at baseline to 125.2 ± 55.7 mcg/day at 2 years; p = 1.000). Differences between groups became significant at 24 months. Daily weight-based LT4 dose increased in the LRYGB group (1.11 ± 0.38 mcg/kg day at baseline to 1.57 ± 0.74 mcg/kg day at 2 years; p = 0.005) with no significant changes in the LSG group (1.15 ± 0.35 mcg/kg day at baseline vs 1.11 ± 0.49 mcg/kg day at 2 years; p = 1.000). CONCLUSION: LRYGB and LSG showed different changes in LT4 requirements 2 years after surgery. There was an early decrease in daily total LT4 dose requirements after LSG, which suggests an early preventive reduction to be validated in future studies.