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).

Increasing the complexity of lipoprotein characterization for cardiovascular risk in type 2 diabetes.

The burden of cardiovascular disease is particularly high among individuals with diabetes, even when LDL cholesterol is normal or within the therapeutic target. Despite this, cholesterol accumulates in their arteries, in part, due to persistent atherogenic dyslipidaemia characterized by elevated triglycerides, remnant cholesterol, smaller LDL particles and reduced HDL cholesterol. The causal link between dyslipidaemia and atherosclerosis in T2DM is complex, and our contention is that a deeper understanding of lipoprotein composition and functionality, the vehicle that delivers cholesterol to the artery, will provide insight for improving our understanding of the hidden cardiovascular risk of diabetes. This narrative review covers three levels of complexity in lipoprotein characterization: 1-the information provided by routine clinical biochemistry, 2-advanced nuclear magnetic resonance (NMR)-based lipoprotein profiling and 3-the identification of minor components or physical properties of lipoproteins that can help explain arterial accumulation in individuals with normal LDLc levels, which is typically the case in individuals with T2DM. This document highlights the importance of incorporating these three layers of lipoprotein-related information into population-based studies on ASCVD in T2DM. Such an attempt should inevitably run in parallel with biotechnological solutions that allow large-scale determination of these sets of methodologically diverse parameters.

PCSK9 inhibitors on the management of primary and secondary cardiovascular prevention.

BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have represented an important change in the management of hypercholesterolemia, although, until now, they have barely been used. Without PCSK9i, many patients with atherosclerotic cardiovascular disease (CVD) or those at very high risk do not reach their therapeutic LDLc objectives. OBJECTIVE: The analysis aimed to examine the clinical and biochemical characteristics of subjects receiving PCSK9i treatment in the Dyslipidemia Registry of the Spanish Atherosclerosis Society. METHODS: All consecutive subjects aged ≥ 18 years from different Lipid Units included in the Dyslipidemia Registry of the SEA were analyzed. Inclusion criteria consisted of unrelated patients aged ≥ 18 at the time of inclusion with hypercholesterolemia (LDL-C ≥ 130 mg/dL or non-HDL-C ≥ 160 mg/dL after the exclusion of secondary causes) who were studied for at least two years after inclusion. Participants' baseline and final visit clinical and biochemical characteristics were analyzed based on whether they were on primary or secondary prevention and whether they were taking PCSK9i at the end of follow-up. RESULTS: Eight hundred twenty-nine patients were analyzed, 7014 patients in primary prevention and 1281 in secondary prevention at baseline. 4127 subjects completed the required follow-up for the final analysis. The median follow-up duration was 7 years (IQR 3.0-10.0). Five hundred patients (12.1%) were taking PCSK9i at the end of the follow-up. The percentage of PCSK9i use reached 35.6% (n = 201) and 8.7% (n = 318) in subjects with and without CVD, respectively. Subjects on PCSK9i and oral lipid-lowering agents with and without CVD achieved LDLc reductions of 80.3% and 75.1%, respectively, concerning concentrations without lipid-lowering drugs. Factors associated with PCSK9i use included increasing age, LDLc without lipid-lowering drugs and the Dutch Lipid Clinic Network (DLCN) score. However, hypertension, diabetes, smoking, and LDLc after oral lipid-lowering drugs were not independent factors associated with PCSK9i prescription. In subjects with CVD, the use of PCSK9i was higher in men than in women (an odds ratio of 1.613, P = 0.048). CONCLUSIONS: Approximately one-third of CVD patients received PCSK9i at the end of follow-up. The use of PCSK9i was more focused on baseline LDLc concentrations rather than on CVD risk. Women received less PCSK9i in secondary prevention compared to men.

Role of Leptin in Obesity, Cardiovascular Disease, and Type 2 Diabetes.

Diabetes mellitus (DM) is a highly prevalent disease worldwide, estimated to affect 1 in every 11 adults; among them, 90-95% of cases are type 2 diabetes mellitus. This is partly attributed to the surge in the prevalence of obesity, which has reached epidemic proportions since 2008. In these patients, cardiovascular (CV) risk stands as the primary cause of morbidity and mortality, placing a substantial burden on healthcare systems due to the potential for macrovascular and microvascular complications. In this context, leptin, an adipocyte-derived hormone, plays a fundamental role. This hormone is essential for regulating the cellular metabolism and energy balance, controlling inflammatory responses, and maintaining CV system homeostasis. Thus, leptin resistance not only contributes to weight gain but may also lead to increased cardiac inflammation, greater fibrosis, hypertension, and impairment of the cardiac metabolism. Understanding the relationship between leptin resistance and CV risk in obese individuals with type 2 DM (T2DM) could improve the management and prevention of this complication. Therefore, in this narrative review, we will discuss the evidence linking leptin with the presence, severity, and/or prognosis of obesity and T2DM regarding CV disease, aiming to shed light on the potential implications for better management and preventive strategies.

Resilient Older Subjects with Heterozygous Familial Hypercholesterolemia, Baseline Differences and Associated Factors.

Despite elevated low-density lipoprotein (LDL) cholesterol levels, some older subjects with heterozygous familial hypercholesterolemia (HeFH) do not develop atherosclerotic cardiovascular disease (ACVD) during their lifetime. The factors related to this resilient state have not been fully established. The aim of this study was to evaluate differential characteristics between older HeFH subjects with and without ACVD and factors associated with the presence of ACVD. Subjects were part of the Spanish Atherosclerosis Society Dyslipidemia Registry, and those ≥ 70 years old and with HeFH were included. Baseline characteristics of these subjects with and without ACVD were compared. A multivariate analysis was performed to assess factors associated with the presence of ACVD. A total of 2148 subjects with HeFH were included. Resilient subjects were mostly female, younger and presented fewer comorbidities with respect to the ACVD group. Subjects without ACVD had higher baseline high-density lipoprotein (HDL) cholesterol (55.8 ± 17.1 vs. 47.9 ± 15.4 mg/dL; p < 0.001) and lower lipoprotein(a) [Lp(a)] (53.4 ± 67.9 vs. 66.6 ± 85.6 mg/dL; p < 0.001) levels with respect to those in the ACVD group. Lp(a) and the presence of ≥3 risk factors were associated with the presence of ACVD.

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.

One abnormal value or vomiting after oral glucose tolerance test in pregnancy: incidence and impact on maternal-fetal outcomes.

OBJECTIVE: To analyze pregnancy outcomes of women with one abnormal value (OAV) during oral glucose tolerance test (OGTT) or OGTT-intolerance, compared with gestational diabetes mellitus (GDM) and normal glucose tolerance (NGT) pregnant women, according to whether they received any health intervention or not. METHODS: An observational retrospective study was designed including pregnant women who gave birth at Hospital del Mar, Barcelona (Spain) during December/2014-July/2018. Baseline characteristics, pregnancy outcomes and health interventions were obtained from a database collected previously for other study. Inclusion criteria were singleton pregnancies with OAV or OGTT-intolerants who gave birth at the Hospital. GDM screening followed a two-step approach: 50 g O'Sullivan test and 100 g 3-hour OGTT if the former was abnormal. RESULTS: From a total of 2,662 pregnancies, 326 (12.2%) had GDM, 87 OAV (3.3%), 65 OGTT intolerance (2.4%) and 2,184 were NGT women. First trimester HbA1c in both OAV and OGTT-intolerant women was significantly higher than in NGT group, and significantly lower than in GDM pregnants. No differences in obstetric outcomes were found between OGTT-intolerants and NGT/GDM groups. Treated OGTT-intolerants had greater gestational age at delivery than non-treated ones (weeks, 39.6 ± 1.2 vs 38.0 ± 4.0, respectively). In OAV women, significant differences were observed in newborns' birthweight (g, 3227.3 ± 500.8 vs 3351.1 ± 436.7, vs GDM) and gestational age at birth (weeks, 38.7 ± 1.8 vs 39.3 ± 1.9, vs NGT), but not in macrosomia/pre-eclampsia. No differences were found according to treatment in OAV. CONCLUSIONS: OAV and OGTT-intolerants account for a third of pregnant women referred to Diabetes Unit. Their rates of preterm birth, pre-eclampsia and macrosomia were not different from NGT or GDM women.

LDL Cholesterol Reduction Variability with Different Types and Doses of Statins in Monotherapy or Combined with Ezetimibe. Results from the Spanish Arteriosclerosis Society Dyslipidaemia Registry.

PURPOSE: Low-density lipoprotein (LDL) cholesterol reduction by statin therapy is dose-dependent, varies among different statins, and has wide inter-individual variability. The present study aimed to compare mean LDL cholesterol reduction and its variability achieved with different doses of the three statins most frequently used in monotherapy or combined with ezetimibe in a real clinical setting. METHODS: Of 5620 cases with primary hypercholesterolemia on the Spanish Arteriosclerosis Society Registry, 1004 with non-familial hypercholesterolemia and complete information on drug therapy and lipid profile were included. RESULTS: The lowest mean percentage LDL cholesterol reduction was observed with simvastatin 10 mg (32.5 ± 18.5%), while the highest mean percentage LDL reduction was obtained with rosuvastatin 40 mg (58.7 ± 18.8%). As to combined treatment, the lowest and highest mean percentage LDL cholesterol reductions were obtained with simvastatin 10 mg combined with ezetimibe (50.6 ± 24.6%) and rosuvastatin 40 mg combined with ezetimibe (71.6 ± 11.1%), respectively. Factors associated with a suboptimal response were male sex, lower age, body mass index, and baseline LDL cholesterol levels. Combined treatment was associated with less variability in LDL cholesterol reduction (OR 0.603, p < 0.001). CONCLUSION: In a real clinical setting, rosuvastatin was superior to the other statins in lowering LDL cholesterol, both as monotherapy or combined with ezetimibe. Factors associated with a suboptimal response in LDL cholesterol decline were male sex, age, body mass index, and baseline LDL cholesterol levels. Combined treatment was associated with less variability in LDL cholesterol improvement.

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.

Impact of statin therapy on LDL and non-HDL cholesterol levels in subjects with heterozygous familial hypercholesterolaemia.

BACKGROUND AND AIMS: Cardiovascular risk in heterozygous familial hypercholesterolaemia (HeFH) is driven by LDL cholesterol levels. Since lipid response to statin therapy presents individual variation, this study aimed to compare mean LDL and non-HDL cholesterol reductions and their variability achieved with different types and doses of the most frequently prescribed statins. METHODS AND RESULTS: Among primary hypercholesterolaemia cases on the Spanish Arteriosclerosis Society registry, 2894 with probable/definite HeFH and complete information on drug therapy and lipid profile were included. LDL cholesterol reduction ranged from 30.2 ± 17.0% with simvastatin 10 mg to 48.2 ± 14.7% with rosuvastatin 40 mg. After the addition of ezetimibe, an additional 26, 24, 21 and 24% reduction in LDL cholesterol levels was obtained for rosuvastatin, 5, 10, 20 and 40 mg, respectively. Subjects with definite HeFH and a confirmed genetic mutation had a more discrete LDL cholesterol reduction compared to definite HeFH subjects with no genetic mutation. A suboptimal response (<15% or <30% reduction in LDL cholesterol levels, respectively with low-/moderate-intensity and high-intensity statin therapy) was observed in 13.5% and, respectively, 20.3% of the subjects. CONCLUSION: According to the LDL cholesterol reduction in HeFH patients, the ranking for more to less potent statins was rosuvastatin, atorvastatin and simvastatin; however, at maximum dosage, atorvastatin and rosuvastatin were nearly equivalent. HeFH subjects with positive genetic diagnosis had a lower lipid-lowering response. Approximately 1 in 5 patients on high-intensity statin therapy presented a suboptimal response.

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.

Impact of overt diabetes diagnosed in pregnancy in a multi-ethnic cohort in Spain.

Overt diabetes (ODM) is defined as women without diabetes meeting the criteria for diabetes at the first antenatal visit. The risk of obstetric complications increases linearly with maternal glycemia and poorer maternal-fetal outcomes than in gestational diabetes (GDM) may be expected. Studies focusing on ODM pregnancy outcomes are lacking. We aimed to analyze maternal characteristics and pregnancy outcomes in ODM women compared with those with GDM. A retrospective cohort study of women giving birth between January 2010 and April 2013 was conducted. Participants with pre-gestational diabetes were excluded. All women underwent screening for GDM at the 24th-28th weeks of gestation or at the first prenatal visit in those with risk factors. HbA1c and a fasting glucose were measured in GDM women to rule out ODM. Of the 5,633 women included, 572 (10%) were diagnosed with GDM and 50 (0.88%) with ODM. Almost 95% of ODM women were from ethnic minorities. After adjustment for confounding factors, ODM women showed increased rates of premature birth (23.1% vs. 6.7%, p < .001), emergent cesarean section (41.0% vs. 19.5%, p = .049), preeclampsia (22% vs. 3.7%, p < .001) and large-for-gestational-age babies (40.0% vs. 14.8%, p = .008) compared with GDM. In conclusion, ODM is associated with poorer obstetric outcomes than GDM and affects mainly women from ethnic minorities.

Metabolic syndrome among individuals with heroin use disorders on methadone therapy: Prevalence, characteristics, and related factors.

BACKGROUND: Observational studies have reported a high prevalence of obesity and diabetes in subjects on methadone therapy; there are, however, limited data about metabolic syndrome. The aim of the study was to evaluate the prevalence of metabolic syndrome and related factors in individuals with heroin use disorder on methadone therapy. METHODS: A cross-sectional study in individuals with heroin use disorder on methadone therapy at a drug abuse outpatient center. Medical examinations and laboratory analyses after a 12-hour overnight fast were recorded. Metabolic syndrome was diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (ATP III) criteria. RESULTS: One hundred and twenty-two subjects were included, with a mean age of 46.1 ± 9 years, a median body mass index (BMI) of 25.3 kg/m2 (interquartile range [IQR]: 21.2-28), and 77.9% were men. Median exposure to methadone therapy was 13 years (IQR: 5-20). Overweight and obesity were present in 29.5% and 17.2% of the participants, respectively. Metabolic syndrome components were low high-density lipoprotein (HDL) cholesterol (51.6%), hypertriglyceridemia (36.8%), high blood pressure (36.8%), abdominal obesity (27.0%), and raised blood glucose levels (18.0%). Abdominal obesity was more prevalent in women (52% vs. 20%, P = >0.01) and high blood pressure more prevalent in men (41.1% vs. 22.2%, P = .07). Prevalence of metabolic syndrome was 29.5% (95% confidence interval [CI]: 16.6-31.8). In the multivariate logistic regression analysis, BMI (per 1 kg/m2 increase odds ratio [OR]: 1.49, 95% CI: 1.27-1.76) and exposure time to methadone therapy (per 5 years of treatment increase OR: 1.38, 95% CI: 1.28-1.48) were associated with metabolic syndrome. CONCLUSIONS: Overweight and metabolic syndrome are prevalent findings in individuals with heroin use disorder on methadone therapy. Of specific concern is the association of methadone exposure with metabolic syndrome. Preventive measures and clinical routine screening should be recommended to prevent metabolic syndrome in subjects on methadone therapy.

Impact of anthropometric features on the applicability and accuracy of FibroScan® (M and XL) in overweight/obese patients.

BACKGROUND AND AIM: Transient elastography is the reference method for liver stiffness measurement (LSM) in the general population, having lower applicability in obese patients. We evaluated the applicability and diagnostic accuracy of the M and XL probes in overweight/obese patients to establish the most appropriate approach. METHODS: From May 2013 to March 2015, we evaluated patients with a body mass index (BMI) ≥ 28 kg/m2 . We constructed an algorithm with variables independently related to unreliable LSM with the M probe. RESULTS: A total of 1084 patients were evaluated. M and XL probe applicability was 88.8% and 98%, respectively. Waist circumference (WC) (OR; 95% CI; P) (0.97; 0.94-0.99; P < 0.001) and skin-capsule distance (SCD) (0.83; 0.79-0.87; P < 0.001) were independently related to unreliable LSM (M probe). The SCD was > 25 mm in 5.5% of individuals with a BMI ≤ 35 kg/m2 and a WC ≤ 117 cm, with LSM (M probe) applicability rising to 94.3%. In contrast, 36.9% of patients with a BMI > 35 kg/m2 and/or a WC > 117 cm presented an SCD > 25 mm, with M probe applicability being 73.1%. The diagnostic accuracy (area under the receiver operator characteristic) using the M probe to identify significant steatosis (0.76), fibrosis (0.89), and cirrhosis (0.96) was very high in patients with a BMI ≤ 35 kg/m2 and a WC ≤ 117 cm. CONCLUSIONS: The applicability and accuracy of the FibroScan® M probe to identify fibrosis and steatosis was excellent in overweight and obesity grade I (BMI ≤ 35 kg/m2 ) with a WC ≤ 117 cm. The XL probe increased the applicability of transient elastography in obesity grade II-III (BMI > 35 kg/m2 ).

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.

[Diabetes mellitus and cardiovascular risk: Working group recommendations of Diabetes and Cardiovascular Disease of the Spanish Society of Diabetes (SED, 2015)]. / Diabetes mellitus y riesgo cardiovascular: recomendaciones del Grupo de Trabajo Diabetes y Enfermedad Cardiovascular de la Sociedad Española de Diabetes (SED, 2015).

The present paper updates the Clinical Practice Recommendations for the management of cardiovascular risk factors (CVRF) in diabetes mellitus. This is a medical consensus agreed by an independent panel of experts from the Spanish Society of Diabetes (SED). Several consensuses have been proposed by scientific and medical Societies to achieve clinical goals. However, the risk score for general population may lack sensitivity for individual assessment or for particular groups at risk, such as diabetics. Traditional risk factors together with non-traditional factors are reviewed throughout this paper. Intervention strategies for managing CVRF in the diabetic patient are reviewed in detail: balanced food intake, weight reduction, physical exercise, smoking cessation, reduction in HbA1c, therapy for high blood pressure, obesity, lipid disorders, and platelet anti-aggregation. It is hoped that these guidelines can help clinicians in the decisions of their clinical activity. This regular update by the SED Cardiovascular Disease Group of the most relevant concepts, and of greater practical and realistic clinical interest, is presented in order to reduce CVR of diabetics.

Association between plasma triglycerides and high-density lipoprotein cholesterol and microvascular kidney disease and retinopathy in type 2 diabetes mellitus: a global case-control study in 13 countries.

BACKGROUND: Microvascular renal and retinal diseases are common major complications of type 2 diabetes mellitus. The relation between plasma lipids and microvascular disease is not well established. METHODS AND RESULTS: The case subjects were 2535 patients with type 2 diabetes mellitus with an average duration of 14 years, 1891 of whom had kidney disease and 1218 with retinopathy. The case subjects were matched for diabetes mellitus duration, age, sex, and low-density lipoprotein cholesterol to 3683 control subjects with type 2 diabetes mellitus who did not have kidney disease or retinopathy. The study was conducted in 24 sites in 13 countries. The primary analysis included kidney disease and retinopathy cases. Matched analysis was performed by use of site-specific conditional logistic regression in multivariable models that adjusted for hemoglobin A1c, hypertension, and statin treatment. Mean low-density lipoprotein cholesterol concentration was 2.3 mmol/L. The microvascular disease odds ratio increased by a factor of 1.16 (95% confidence interval, 1.11-1.22) for every 0.5 mmol/L (≈1 quintile) increase in triglycerides or decreased by a factor of 0.92 (0.88-0.96) for every 0.2 mmol/L (≈1 quintile) increase in high-density lipoprotein cholesterol. For kidney disease, the odds ratio increased by 1.23 (1.16-1.31) with triglycerides and decreased by 0.86 (0.82-0.91) with high-density lipoprotein cholesterol. Retinopathy was associated with triglycerides and high-density lipoprotein cholesterol in matched analysis but not significantly after additional adjustment. CONCLUSIONS: Diabetic kidney disease is associated worldwide with higher levels of plasma triglycerides and lower levels of high-density lipoprotein cholesterol among patients with good control of low-density lipoprotein cholesterol. Retinopathy was less robustly associated with these lipids. These results strengthen the rationale for studying dyslipidemia treatment to prevent diabetic microvascular disease.

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.