Impact of mediterranean diet promotion on environmental sustainability: a longitudinal analysis.

OBJECTIVE: This article aims to estimate the differences in environmental impact (greenhouse gas [GHG] emissions, land use, energy used, acidification and potential eutrophication) after one year of promoting a Mediterranean diet (MD). METHODS: Baseline and 1-year follow-up data from 5800 participants in the PREDIMED-Plus study were used. Each participant's food intake was estimated using validated semi-quantitative food frequency questionnaires, and the adherence to MD using the Dietary Score. The influence of diet on environmental impact was assessed through the EAT-Lancet Commission tables. The influence of diet on environmental impact was assessed through the EAT-Lancet Commission tables. The association between MD adherence and its environmental impact was calculated using adjusted multivariate linear regression models. RESULTS: After one year of intervention, the kcal/day consumed was significantly reduced (-125,1 kcal/day), adherence to a MD pattern was improved (+0,9) and the environmental impact due to the diet was significantly reduced (GHG: -361 g/CO2-eq; Acidification:-11,5 g SO2-eq; Eutrophication:-4,7 g PO4-eq; Energy use:-842,7 kJ; and Land use:-2,2 m2). Higher adherence to MD (high vs. low) was significantly associated with lower environmental impact both at baseline and one year follow-up. Meat products had the greatest environmental impact in all the factors analysed, both at baseline and at one-year follow-up, in spite of the reduction observed in their consumption. CONCLUSIONS: A program promoting a MD, after one year of intervention, significantly reduced the environmental impact in all the factors analysed. Meat products had the greatest environmental impact in all the dimensions analysed.

Intensive Weight-Loss Lifestyle Intervention Using Mediterranean Diet and COVID-19 Risk in Older Adults: Secondary Analysis of PREDIMED-Plus Trial.

OBJECTIVES: We tested the effects of a weight-loss intervention encouraging energy-reduced MedDiet and physical activity (PA) in comparison to ad libitum MedDiet on COVID-19 incidence in older adults. DESIGN: Secondary analysis of PREDIMED-Plus, a prospective, ongoing, multicentre randomized controlled trial. SETTING: Community-dwelling, free-living participants in PREDIMED-Plus trial. PARTICIPANTS: 6,874 Spanish older adults (55-75 years, 49% women) with overweight/obesity and metabolic syndrome. INTERVENTION: Participants were randomised to Intervention (IG) or Control (CG) Group. IG received intensive behavioural intervention for weight loss with an energy-reduced MedDiet intervention and PA promotion. CG was encouraged to consume ad libitum MedDiet without PA recommendations. MEASUREMENTS: COVID-19 was ascertained by an independent Event Committee until December 31, 2021. COX regression models compared the effect of PREDIMED-Plus interventions on COVID-19 risk. RESULTS: Overall, 653 COVID-19 incident cases were documented (IG:317; CG:336) over a median (IQR) follow-up of 5.8 (1.3) years (inclusive of 4.0 (1.2) years before community transmission of COVID-19) in both groups. A significantly lowered risk of COVID-19 incidence was not evident in IG, compared to CG (fully-adjusted HR (95% CI): 0.96 (0.81,1.12)). CONCLUSIONS: There was no evidence to show that an intensive weight-loss intervention encouraging energy-reduced MedDiet and PA significantly lowered COVID-19 risk in older adults with overweight/obesity and metabolic syndrome in comparison to ad libitum MedDiet. Recommendations to improve adherence to MedDiet provided with or without lifestyle modification suggestions for weight loss may have similar effects in protecting against COVID-19 risk in older adults with high cardiovascular risks.

Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes.

Antigen-specific immunotherapy is an immunomodulatory strategy for autoimmune diseases, such as type 1 diabetes, in which patients are treated with autoantigens to promote immune tolerance, stop autoimmune ß-cell destruction and prevent permanent dependence on exogenous insulin. In this study, human proinsulin peptide C19-A3 (known for its positive safety profile) was conjugated to ultrasmall gold nanoparticles (GNPs), an attractive drug delivery platform due to the potential anti-inflammatory properties of gold. We hypothesised that microneedle intradermal delivery of C19-A3 GNP may improve peptide pharmacokinetics and induce tolerogenic immunomodulation and proceeded to evaluate its safety and feasibility in a first-in-human trial. Allowing for the limitation of the small number of participants, intradermal administration of C19-A3 GNP appears safe and well tolerated in participants with type 1 diabetes. The associated prolonged skin retention of C19-A3 GNP after intradermal administration offers a number of possibilities to enhance its tolerogenic potential, which should be explored in future studies.

Conocimientos y prácticas sobre foto protección en bañistas de ocho playas de Lima / Knowledge and practices of photoprotection in bathers of eight beaches of Lima

Resumen INTRODUCCIÓN : La radiación ultravioleta solar puede resultar perjudicial para la salud y provocar desde quemaduras hasta enfermedades como el cáncer, por ello, el cuidado frente a la alta radiación solar es importante. OBJETIVOS : El objetivo general del presente estudio fue determinar si existe asociación entre los conocimientos y las prácticas sobre foto protecciónen los bañistas peruanos. MATERIALES Y MÉTODOS : Se realizó un estudio trasversal analítico con 380 bañistas peruanos en ocho playas de Lima. Los participantes respondieron un cuestionario donde se recopiló información de los conocimientos y las prácticas de foto protección. Los conocimientos se categorizaron en altos y bajos, y las prácticas en adecuadas e inadecuadas. Para el análisis se empleó la prueba de Chi cuadrado de Pearson y el modelo de regresión de Poisson ajustado por la edad, sexo, nivel educativo y estado civil. RESULTADOS : Se encontró que la práctica de protección adecuada más frecuente fue el uso de foto protector(63%) y la menos frecuente fue el uso adecuado de manga larga y pantalón largo (9,7%). También se evidenció una relación entre los conocimientos altos y tres prácticas fundamentales: uso de foto protector, sombrilla y lentes de sol. CONCLUSIONES : En la muestra de bañistas peruanos, los participantes reportaronde manera general prácticas de foto proteccióndeficientes; además, el poseer conocimientos acerca de la protección solar no aseguró una práctica adecuada de todas las medidas de foto protección.

Abstract INTRODUCTION : Ultraviolet rays can have damaging health effects and cause from sunburn all the way up to diseases such as cancer. Thus, precautionary measures against intense solar radiation are important. OBJECTIVES: The overall objective of this study was to determine whether there is an association between photoprotection knowledge and practices in Peruvianbeach-goers. MATERIALS AND METHODS : An analytical cross-sectional study comparing survey and observational data obtained from 380 Peruvians at eight beaches in Lima was conducted. The participants answered a questionnaire where knowledge was categorized into high and low, and reported practices were dichotomized as appropriate and inappropriate. For variable analysis, Chi square test of Pearson and Poisson regression model adjusted for age, sex, education level and marital status were used. RESULTS : It was found that the most common reported appropriate practice of photoprotection was the use of sunscreen (63%) and the least frequent was the appropriate use of a long sleeve t-shirt and long pants (9.7%). It was also evident that there is a significant relationship between high knowledge and three core practices, including use of sunscreen, beach umbrellas and sunglasses. CONCLUSIONS : In this sample of Peruvian beach-goers, participants generally reported poor photoprotection practices; furthermore, knowledge about sun protection did not assure the practice of all photoprotection measures.

A Community Program of Integrated Care for Frail Older Adults: +AGIL Barcelona.

OBJECTIVES: To assess the 3-month impact on physical function of a program for community-dwelling frail older adults, based on the integration of primary care, geriatric medicine, and community resources, implemented in "real life". DESIGN: Interventional cohort study. SETTING: Primary care in Barcelona, Spain. PARTICIPANTS: Individuals aged ≥80 years (n=134), presenting at least one sign of frailty (i.e., slow gait speed, weakness, memory complaints, involuntary weight loss, poor social support). INTERVENTION: After frailty screening by the primary care team, candidates were referred to a geriatric team (geriatrician + physical therapist), who performed a comprehensive geriatric assessment and designed a tailored multidisciplinary intervention in the community, including a) multi-modal physical activity (PA) sessions, b) promotion of adherence to a Mediterranean diet c) health education and d) medication review. MEASUREMENTS: Participants were assessed based on a comprehensive geriatric assessment including physical performance (Short Physical Performance Battery -SPPB- and gait speed), at baseline and at a three month follow-up. RESULTS: A total of 112 (83.6%) participants (mean age=80.8 years, 67.9% women) were included in this research. Despite being independent in daily life, participants' physical performance was impaired (SPPB=7.5, SD=2.1, gait speed=0.71, SD=0.20 m/sec). After three months, 90.2% of participants completed ≥7.5 physical activity sessions. The mean improvements were +1.47 (SD 1.64) points (p<0.001) for SPPB, +0.08 (SD 0.13) m/sec (p<0.001) for gait speed, -5.5 (SD 12.10) sec (p<0.001) for chair stand test, and 53% (p<0.001) improved their balance. Results remained substantially unchanged after stratifying the analyses according to the severity of frailty. CONCLUSIONS: Our results suggested that a "real-world" multidisciplinary intervention, integrating primary care, geriatric care, and community services may improve physical function, a marker of frailty, within 3 months. Further studies are needed to address the long-term impact and scalability of this implementation program.

Micro ad-hoc Health Social Networks (uHSN). Design and evaluation of a social-based solution for patient support.

OBJECTIVE: To contribute the design, development, and assessment of a new concept: Micro ad hoc Health Social Networks (uHSN), to create a social-based solution for supporting patients with chronic disease. DESIGN: After in-depth fieldwork and intensive co-design over a 4-year project following Community-Based Participatory Research (CBPR), this paper contributes a new paradigm of uHSN, defining two interaction areas (the "backstage", the sphere invisible to the final user, where processes that build services take place; and the "onstage", the visible part that includes the patients and relatives), and describes a new transversal concept, i.e., "network spaces segments," to provide timely interaction among all involved profiles and guaranteeing qualitative relationships. This proposal is applicable to any service design project and to all types of work areas; in the present work, it served as a social-based solution for supporting patients with chronic disease in two real-life health scenarios: a Parkinson disease patient association and a Stroke rehabilitation service in a hospital. These two scenarios included the following main features: thematic (related to the specific disease), private, and secure (only for the patient, relatives, healthcare professional, therapist, carer), with defined specific objectives (around patient support), small size (from tens to hundreds of users), ability to integrate innovative services (e.g., connection to hospital information service or to health sensors), supported by local therapeutic associations, and clustered with preconfigured relationships among users based in network groups. MEASUREMENTS: Using a mixed qualitative and quantitative approach for 6 months, the performance of the uHSN was assessed in the two environments: a hospital rehabilitation unit working with Stroke patients, and a Parkinson disease association providing physiotherapy, occupational therapy, psychological support, speech therapy, and social services. We describe the proposed methods for evaluating the uHSN quantitatively and qualitatively, and how the scientific community can replicate and/or integrate this contribution in its research. RESULTS: The uHSN overcomes the main limitations of traditional HSNs in the main areas recommended in the literature: privacy, security, transparency, system ecology, Quality of Service (QoS), and technology enhancement. The qualitative and quantitative research demonstrated its viability and replicability in four key points: user acceptance, productivity improvement, QoS enhancement, and fostering of social relations. It also meets the expectation of connecting health and social worlds, supporting distance rehabilitation, improving professionals' efficiency, expanding users' social capital, improving information quality and immediacy, and enhancing perceived peer/social/emotional support. The scientific contributions of the present paper are the first step not only in customizing health solutions that empower patients, their families, and healthcare professionals, but also in transferring this new paradigm to other scientific, professional, and social environments to create new opportunities.

Reproductive traits and evolutionary divergence between Mediterranean crops and their wild relatives.

Changes in reproductive traits associated with domestication critically determine the evolutionary divergence between crops and their wild relatives, as well as the potential of crop plants to become feral. In this review, we examine the genetic mechanisms of plant domestication and the different types of selection involved, and describe the particularities of domestication of Mediterranean field crops with regard to their reproductive traits, showing illustrative examples. We also explore gene flow patterns between Mediterranean field crops and their wild relatives, along with their ecological, evolutionary and economic implications. Domestication entails multiple selective processes, including direct selection, environmental adaptation and developmental constraints. In contrast to clonal propagation in perennials, sexual reproduction and seed propagation in annuals and biennials have led to a distinct pathway of evolution of reproductive traits. Thus, the initial domestication and further breeding of Mediterranean field crops has brought about changes in reproductive traits, such as higher mean values and variance of seed and fruit sizes, reduced fruit and seed toxicity, non-shattering seeds and loss of seed dormancy. Evolution under domestication is not a linear process, and bi-directional gene flow between wild and crop taxa is a frequent phenomenon. Thus, hybridisation and introgression have played a very important role in determining the genetics of current cultivars. In turn, gene flow from crops to wild relatives can lead to introgression of crop genes into wild populations and potentially alter the characteristics of natural communities. In conclusion, plant evolution under domestication has not only changed the reproductive biology of cultivated taxa, its effects are multifaceted and have implications beyond agriculture.

Adherence to Mediterranean diet is associated with methylation changes in inflammation-related genes in peripheral blood cells

Epigenetic processes, including DNA methylation, might be modulated by environmental factors such as the diet, which in turn have been associated with the onset of several diseases such as obesity or cardiovascular events. Meanwhile, Mediterranean diet (MedDiet) has demonstrated favourable effects on cardiovascular risk, blood pressure, inflammation and other complications related to excessive adiposity. Some of these effects could be mediated by epigenetic modifications. Therefore, the objective of this study was to investigate whether the adherence to MedDiet is associated with changes in the methylation status from peripheral blood cells. A subset of 36 individuals was selected within the Prevención con Dieta Mediterránea (PREDIMED)-Navarra study, a randomised, controlled, parallel trial with three groups of intervention in high cardiovascular risk volunteers, two with a MedDiet and one low-fat control group. Changes in methylation between baseline and 5 years were studied. DNA methylation arrays were analysed by several robust statistical tests and functional classifications. Eight genes related to inflammation and immunocompetence (EEF2, COL18A1, IL4I1, LEPR, PLAGL1, IFRD1, MAPKAPK2, PPARGC1B) were finally selected as changes in their methylation levels correlated with adherence to MedDiet and because they presented sensitivity related to a high variability in methylation changes. Additionally, EEF2 methylation levels positively correlated with concentrations of TNF-alfa and CRP. This report is apparently the first showing that adherence to MedDiet is associated with the methylation of the reported genes related to inflammation with a potential regulatory impact

Adherence to Mediterranean diet is associated with methylation changes in inflammation-related genes in peripheral blood cells.

Epigenetic processes, including DNA methylation, might be modulated by environmental factors such as the diet, which in turn have been associated with the onset of several diseases such as obesity or cardiovascular events. Meanwhile, Mediterranean diet (MedDiet) has demonstrated favourable effects on cardiovascular risk, blood pressure, inflammation and other complications related to excessive adiposity. Some of these effects could be mediated by epigenetic modifications. Therefore, the objective of this study was to investigate whether the adherence to MedDiet is associated with changes in the methylation status from peripheral blood cells. A subset of 36 individuals was selected within the Prevención con Dieta Mediterránea (PREDIMED)-Navarra study, a randomised, controlled, parallel trial with three groups of intervention in high cardiovascular risk volunteers, two with a MedDiet and one low-fat control group. Changes in methylation between baseline and 5 years were studied. DNA methylation arrays were analysed by several robust statistical tests and functional classifications. Eight genes related to inflammation and immunocompetence (EEF2, COL18A1, IL4I1, LEPR, PLAGL1, IFRD1, MAPKAPK2, PPARGC1B) were finally selected as changes in their methylation levels correlated with adherence to MedDiet and because they presented sensitivity related to a high variability in methylation changes. Additionally, EEF2 methylation levels positively correlated with concentrations of TNF-α and CRP. This report is apparently the first showing that adherence to MedDiet is associated with the methylation of the reported genes related to inflammation with a potential regulatory impact.

Trombo flotante de aorta torácica y trombosis venosa esplácnica: a propósito de 2 casos / Floating thoracic aortic thrombus and splanchnic vein thrombosis: A presentation of 2 cases

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Effects of alcohol and polyphenols from beer on atherosclerotic biomarkers in high cardiovascular risk men: a randomized feeding trial.

BACKGROUND AND AIMS: Moderate alcohol consumption exerts a cardioprotective effect, but no studies have evaluated the alcohol-independent cardiovascular effects of the non-alcoholic components of beer. We aimed to evaluate the effects of ethanol and the phenolic compounds of beer on classical and novel cardiovascular risk factors. METHODS AND RESULTS: Thirty-three high risk male volunteers were included in a randomized, crossover feeding trial. After a washout period, all subjects received beer (30 g alcohol/d, 660 mL), the equivalent amount of polyphenols as non-alcoholic beer (990 mL), and gin (30 g alcohol/d, 100 mL) for 4 weeks. All outcomes were evaluated before and after each intervention period. Moderate alcohol consumption increased serum HDL-cholesterol (∼5%), ApoA-I (∼6%), ApoA-II (∼7%) and adiponectin (∼7%), and decreased serum fibrinogen (∼8%), and interleukin (IL)-5 (∼14%) concentrations, whereas the non-alcoholic fraction of beer (mainly polyphenols) increased the receptor antagonist of IL-1 (∼24%), and decreased lymphocyte expression of lymphocyte function-associated antigen-1 (∼11%), lymphocyte and monocyte expression of Sialil-Lewis X (∼16%) and monocyte expression of CCR2 (∼31%), and tumor necrosis factor (TNF)-ß (∼14%) and IL-15 (∼22%) plasma concentrations. No changes were observed in glucose metabolism parameters or in body weight and adiposity parameters. CONCLUSION: The phenolic content of beer reduces leukocyte adhesion molecules and inflammatory biomarkers, whereas alcohol mainly improves the lipid profile and reduces some plasma inflammatory biomarkers related to atherosclerosis.

Diversification and the evolution of dispersal ability in the tribe Brassiceae (Brassicaceae).

BACKGROUND AND AIMS: Dispersal and establishment ability can influence evolutionary processes such as geographic isolation, adaptive divergence and extinction probability. Through these population-level dynamics, dispersal ability may also influence macro-evolutionary processes such as species distributions and diversification. This study examined patterns of evolution of dispersal-related fruit traits, and how the evolution of these traits is correlated with shifts in geographic range size, habitat and diversification rates in the tribe Brassiceae (Brassicaceae). METHODS: The phylogenetic analysis included 72 taxa sampled from across the Brassiceae and included both nuclear and chloroplast markers. Dispersal-related fruit characters were scored and climate information for each taxon was retrieved from a database. Correlations between fruit traits, seed characters, habitat, range and climate were determined, together with trait-dependent diversification rates. KEY RESULTS: It was found that the evolution of traits associated with limited dispersal evolved only in association with compensatory traits that increase dispersal ability. The evolution of increased dispersal ability occurred in multiple ways through the correlated evolution of different combinations of fruit traits. The evolution of traits that increase dispersal ability was in turn associated with larger seed size, increased geographic range size and higher diversification rates. CONCLUSIONS: This study provides evidence that the evolution of increased dispersal ability and larger seed size, which may increase establishment ability, can also influence macro-evolutionary processes, possibly by increasing the propensity for long-distance dispersal. In particular, it may increase speciation and consequent diversification rates by increasing the likelihood of geographic and thereby reproductive isolation.

Planificación preoperatoria con ecodoppler en la revascularización de miembros inferiores / Pre-operative planning with doppler color ultrasound in lower limb arterial revascularization

INTRODUCCIÓN: El objetivo de este estudio es evaluar la validez de la cartografía arterial con ecodoppler respecto a la arteriografía para la detección de lesiones significativas y la planificación preoperatoria en los pacientes con enfermedad arterial periférica (EAP). MATERIALES Y MÉTODOS: Estudio transversal de validación de prueba diagnóstica, incluyendo pacientes consecutivos intervenidos de EAP en nuestro centro. Se registraron variables basales, clínicas y factores de riesgo. Se analizaron los ejes ilio-femoropoplíteos, valorando los parámetros ecográficos de la lesión (estenosis < 50%; 50-69%; ≥ 70% y oclusión) así como la planificación quirúrgica propuesta (endovascular, cirugía abierta o cirugía combinada) comparándolos con los hallazgos arteriográficos, sin valorar los vasos distales. RESULTADOS: Desde enero del 2012 hasta diciembre del 2013 se incluyeron 145 extremidades inferiores de 143 pacientes. El grado de concordancia kappa en la detección de estenosis significativas y oclusiones fue mayor que 0,85 en el sector ilíaco, de uno en el sector femoral y 0,98 en el sector poplíteo. El grado de concordancia kappa entre el procedimiento indicado en función de la cartografía y el que finalmente se realizó fue 0,75. CONCLUSIONES: Nuestra experiencia muestra que la cartografía arterial con ecodoppler es una técnica válida para la planificación preoperatoria en los pacientes con EAP, presentando mayor grado de concordancia en el segmento femoropoplíteo

INTRODUCTION: The objective of this study is to evaluate the validity of the doppler arterial mapping compared to angiography for the detection of significant lesions, and preoperative planning in patients with peripheral artery disease (PAD).MATERIALS AND METHODS: Cross-validation study of diagnostic test, including consecutive patients with PAD who were treated in our institution. Baseline clinical variables and risk factors were recorded. The ilio-femoro-popliteal axis were analyzed, assessing the ultrasound parameters of the lesion (stenosis <50%, 50-69%,≥70%, or occlusion) and the proposed surgical planning(endovascular, open surgery, or combined surgery) compared with angiographic findings without evaluating the distal vessels. RESULTS: A total of 145 lower limbs of 143 patients were included from January 2012 to December 013. Kappa agreement in the detection of significant stenosis and occlusions was increased to 0.85 in the iliac sector, 1.0 in the femoral sector, and 0.98 in the popliteal sector. The closeness of agreement between the kappa procedure based on mapping and that finally performed was 0.75. CONCLUSIONS: Our experience shows that the arterial mapping with doppler color ultrasound is valid for preoperative planning in patients with PAD, showing a greater degree of consistenc yin the femoro-popliteal segment

Eficacia, tolerancia y seguridad a largo plazo del polietilenglicol 3350 con electrolitos en el tratamiento del estreñimiento funcional en niños / Efficacy, tolerance and safety of polyethylene glycol 3350 plus electrolytes for the treatment of functional constipation in children

OBJETIVO: Evaluar la seguridad renal del tratamiento con polietilenglicol 3350 con electrolitos durante 1, 3 y 6 meses, la tolerancia digestiva y la dosis de eficacia. PACIENTES Y MÉTODOS: Fueron evaluados 3 grupos de 30 pacientes sanos, 2-10 años (media 6,2) con estreñimiento funcional (criterios de Roma III), con 1, 3 y 6 meses de tratamiento. La eficacia fue evaluada por el número de deposiciones/semana y la consistencia de las heces (escala de Bristol). La natriuria y la osmolaridad urinaria se midieron al inicio, 1, 3 y 6 meses. Los principios inmediatos en heces (análisis de reflexión de infrarrojos [FENIR]) y un test de hidrógeno espirado fueron efectuados en el grupo de un mes de tratamiento. RESULTADOS: La dosis efectiva fue de 0,37 g/kg/día (rango 0,18-0,8). El número de deposiciones/semana en la inclusión (2,4 ± 0,64) muestra diferencia significativa (p < 0,001) vs. (6,21 ± 1,5) tras el tratamiento. También se demostró una diferencia significativa en la puntuación en la escala de Bristol (1,9 ± 0,75 vs. 4,9 ± 1,1 [p < 0,001]). La ingesta media de sodio fue de 112 mg (5 mg/kg/día [rango de 4-12 mg/kg/día]). Los valores de sodio y osmolaridad en orina fueron normales en todos los grupos sin diferencia estadística con respecto a controles (90 niños sanos sin tratamiento). Los valores de FENIR fueron normales en todos los pacientes. La prueba de aliento con hidrógeno fue normal, con una media de 7 ppm. CONCLUSIÓN: No se observaron parámetros bioquímicos renales adversos ni alteraciones digestivas. La tolerancia y la eficacia demostraron ser óptimas. El polietilenglicol 3350 con electrolitos puede ser recomendado con seguridad para el tratamiento del estreñimiento funcional en los niños a corto y largo plazo

OBJECTIVE: To assess the renal safety of treatment with polyethylene glycol 3350 with electrolytes at 1, 3 and 6 months, its gastrointestinal tolerance and dose effectiveness. PATIENTS AND METHODS: Three groups of 30 healthy patient aged 2-10 years (mean 6.2 years) who suffered functional constipation (Rome III criteria) with 1, 3 and 6 months of treatment were evaluated. Efficacy was evaluated by the change in the number of stools per week and stool consistency (Bristol scale). Urine screens, sodium and osmolality, were performed at the beginning and after 1, 3 and 6 months of treatment. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed on the one-month treatment group. RESULTS: The mean dose was 0.37 g/kg/day (range 0.18 to 0.8) titrated according to age, weigh tand response. The number of stools per week during treatment (2.4±0.64) showed a significant difference (P<0.001) vs (6.21±1.5) after treatment. There was also a significant difference in the Bristol scale score (1.9±0.75 vs 4.9±1.1 [P<0.001]). The mean sodium intake was 112 mg (5 mg/kg/day [range 4-12 mg/kg/day]). The values of sodium and urine osmolality were normal in all groups with no statistical difference compared to normal control values (90 healthy children without treatment). NIRA values were normal in all patients. The hydrogen breath test was normal with a median of 7 ppm. CONCLUSION: There were no adverse renal biochemical parameters or gastrointestinal disorders. Tolerance and efficacy was shown to be optimal. Polyethylene glycol 3350 with electrolytes can be safely recommended for the treatment of functional constipation in children in the short and long term

Comparative effect of two Mediterranean diets versus a low-fat diet on glycaemic control in individuals with type 2 diabetes.

BACKGROUND/OBJECTIVES: Although benefits have been attributed to the Mediterranean diet, its effect on glycaemic control has not been totally elucidated. The aim of this work was to compare the effect of two Mediterranean diets versus a low-fat diet on several parameters and indices related to glycaemic control in type 2 diabetic subjects. SUBJECTS/METHODS: A multicentric parallel trial was conducted on 191 participants (77 men and 114 women) of the PREDIMED study in order to compare three dietary interventions: two Mediterranean diets supplemented with virgin olive oil (n=67; body mass index (BMI)=29.4±2.9) or mixed nuts (n=74; BMI=30.1±3.1) and a low-fat diet (n=50; BMI=29.8±2.8). There were no drop-outs. Changes in body weight and waist circumference were determined. Insulin resistance was measured by HOMA-IR index, adiponectin/leptin and adiponectin/HOMA-R ratios after 1 year of follow-up. RESULTS: Increased values of adiponectin/leptin ratio (P=0.043, P=0.001 and P<0.001 for low-fat, olive oil and nut diets, respectively) and adiponectin/HOMA-IR ratio (P=0.061, P=0.027 and P=0.069 for low-fat, olive oil and nut diets, respectively) and decreased values of waist circumference (P=0.003, P=0.001 and P=0.001 for low-fat, olive oil and nut diets, respectively) were observed in the three groups. In both Mediterranean diet groups, but not in the low-fat diet group, this was associated with a significant reduction in body weight (P=0.347, P=0.003 and P=0.021 for low-fat, olive oil and nut diets, respectively). CONCLUSIONS: Mediterranean diets supplemented with virgin olive oil or nuts reduced total body weight and improved glucose metabolism to the same extent as the usually recommended low-fat diet.

[Efficacy, tolerance and safety of polyethylene glycol 3350 plus electrolytes for the treatment of functional constipation in children]. / Eficacia, tolerancia y seguridad a largo plazo del polietilenglicol 3350 con electrolitos en el tratamiento del estreñimiento funcional en niños.

OBJECTIVE: To assess the renal safety of treatment with polyethylene glycol 3350 with electrolytes at 1, 3 and 6 months, its gastrointestinal tolerance and dose effectiveness. PATIENTS AND METHODS: Three groups of 30 healthy patient aged 2-10 years (mean 6.2 years) who suffered functional constipation (Rome III criteria) with 1, 3 and 6 months of treatment were evaluated. Efficacy was evaluated by the change in the number of stools per week and stool consistency (Bristol scale). Urine screens, sodium and osmolality, were performed at the beginning and after 1, 3 and 6 months of treatment. Stool sample NIRA (near-infrared reflectance analysis) and hydrogen breath test analysis samples were performed on the one-month treatment group. RESULTS: The mean dose was 0.37g/kg/day (range 0.18 to 0.8) titrated according to age, weight and response. The number of stools per week during treatment (2.4±0.64) showed a significant difference (P<.001) vs (6.21±1.5) after treatment. There was also a significant difference in the Bristol scale score (1.9±0.75 vs 4.9±1.1 [P<.001]). The mean sodium intake was 112mg (5mg/kg/day [range 4-12mg/kg/day]). The values of sodium and urine osmolality were normal in all groups with no statistical difference compared to normal control values (90 healthy children without treatment). NIRA values were normal in all patients. The hydrogen breath test was normal with a median of 7ppm. CONCLUSION: There were no adverse renal biochemical parameters or gastrointestinal disorders. Tolerance and efficacy was shown to be optimal. Polyethylene glycol 3350 with electrolytes can be safely recommended for the treatment of functional constipation in children in the short and long term.

Toolkit para la creación de unidades de úlcera de pie diabético / A toolkit to create diabetic foot ulcer units

Bajo el nombre de «Toolkit para unidades de úlcera de pie diabético» se han diseñado un conjunto de herramientas para facilitar la puesta en marcha, el funcionamiento y la evaluación de este tipo de unidades clínicas. El Toolkit ha sido realizado por 6 cirujanos vasculares y 2 metodólogos, y para su elaboración se han consultado las principales guías de práctica clínica en el manejo del pie diabético. El Toolkit incluye material destinado a atención primaria y otras especialidades fuera del ámbito de la cirugía vascular (conceptos básicos, algoritmos de manejo, recomendaciones de prevención primaria y criterios de derivación a cirugía vascular), y material para el propio servicio de cirugía vascular (recomendaciones sobre los recursos necesarios para montar una unidad de úlcera de pie diabético, algoritmos clínicos de manejo, cuadernos de recogida de datos, base de datos en Microsoft Access y herramientas de evaluación clínica y económica de la unidad) (AU)

Under the name of «The Diabetic Foot Ulcer Units Toolkit» we have designed a set of tools as an aid for the implementation, performance and evaluation of these Clinical Units. The Toolkit has been prepared by 6 vascular surgeons and 2 experts in methodology. Major clinical practice guidelines in the management of diabetic foot were consulted. The Toolkit includes tools for primary care and other specialties outside the field of vascular surgery (basic concepts, criteria for referral to DFUU, initial basic tests and recommendations for clinical management and primary prevention), and tools for vascular surgery service (list of optimal resources for the DFUU implementation, clinical management algorithms, data collection forms, Microsoft Access database, and tools for the clinical and economical evaluation) (AU)

Regulatory T cell phenotype and function 4 years after GAD-alum treatment in children with type 1 diabetes.

Glutamic acid decarboxylase (GAD)(65) formulated with aluminium hydroxide (GAD-alum) was effective in preserving insulin secretion in a Phase II clinical trial in children and adolescents with recent-onset type 1 diabetes. In addition, GAD-alum treated patients increased CD4(+) CD25(hi) forkhead box protein 3(+) (FoxP3(+)) cell numbers in response to in-vitro GAD(65) stimulation. We have carried out a 4-year follow-up study of 59 of the original 70 patients to investigate long-term effects on the frequency and function of regulatory T cells after GAD-alum treatment. Peripheral blood mononuclear cells were stimulated in vitro with GAD65 for 7 days and expression of regulatory T cell markers was measured by flow cytometry. Regulatory T cells (CD4(+) CD25(hi) CD127(lo)) and effector T cells (CD4(+) CD25(-) CD127(+)) were further sorted, expanded and used in suppression assays to assess regulatory T cell function after GAD-alum treatment. GAD-alum-treated patients displayed higher frequencies of in-vitro GAD(65) -induced CD4(+) CD25(+) CD127(+) as well as CD4(+) CD25(hi) CD127(lo) and CD4(+) FoxP3(+) cells compared to placebo. Moreover, GAD(65) stimulation induced a population of CD4(hi) cells consisting mainly of CD25(+) CD127(+) , which was specific of GAD-alum-treated patients (16 of 25 versus one of 25 in placebo). Assessment of suppressive function in expanded regulatory T cells revealed no difference between GAD-alum- and placebo-treated individuals. Regulatory T cell frequency did not correlate with C-peptide secretion throughout the study. In conclusion, GAD-alum treatment induced both GAD(65) -reactive CD25(+) CD127(+) and CD25(hi) CD127(lo) cells, but no difference in regulatory T cell function 4 years after GAD-alum treatment.

Characteristics of in-vitro phenotypes of glutamic acid decarboxylase 65 autoantibodies in high-titre individuals.

Previous studies have indicated phenotypical differences in glutamic acid decarboxylase 65 autoantibodies (GADA) found in type 1 diabetes (T1D) patients, individuals at risk of developing T1D and stiff-person syndrome (SPS) patients. In a Phase II trial using aluminium-formulated GAD(65) (GAD-alum) as an immunomodulator in T1D, several patients responded with high GADA titres after treatment, raising concerns as to whether GAD-alum could induce GADA with SPS-associated phenotypes. This study aimed to analyse GADA levels, immunoglobulin (Ig)G1-4 subclass frequencies, b78- and b96·11-defined epitope distribution and GAD(65) enzyme activity in sera from four cohorts with very high GADA titres: T1D patients (n = 7), GAD-alum-treated T1D patients (n = 9), T1D high-risk individuals (n = 6) and SPS patients (n = 12). SPS patients showed significantly higher GADA levels and inhibited the in-vitro GAD(65) enzyme activity more strongly compared to the other groups. A higher binding frequency to the b78-defined epitope was found in the SPS group compared to T1D and GAD-alum individuals, whereas no differences were detected for the b96·11-defined epitope. GADA IgG1-4 subclass levels did not differ between the groups, but SPS patients had higher IgG2 and lower IgG4 distribution more frequently. In conclusion, the in-vitro GADA phenotypes from SPS patients differed from the T1D- and high-risk groups, and GAD-alum treatment did not induce SPS-associated phenotypes. However, occasional overlap between the groups exists, and caution is indicated when drawing conclusions to health or disease status.