Blood glucose monitoring devices for type 1 diabetes: a journey from the food and drug administration approval to market availability.

Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring. This progress empowers patients to assume greater control over their health, alleviating the burdens associated with their condition, and contributing to the overall alleviation of the healthcare system. The introduction of novel medical devices, whether derived from existing prototypes or originating as innovative creations, necessitates adherence to a rigorous approval process regulated by the Food and Drug Administration (FDA). Diverse device classifications, stratified by their associated risks, dictate distinct approval pathways, each characterized by varying timelines. This review underscores recent advancements in blood glucose monitoring devices primarily based on electrochemical sensors and elucidates their regulatory journey towards FDA approval. The advent of innovative, non-invasive blood glucose monitoring devices holds promise for maintaining stringent glycemic control, thereby preventing T1D-associated comorbidities, and extending the life expectancy of affected individuals.

Gene-environment interaction in the pathophysiology of type 1 diabetes.

Type 1 diabetes (T1D) is a complex metabolic autoimmune disorder that affects millions of individuals worldwide and often leads to significant comorbidities. However, the precise trigger of autoimmunity and disease onset remain incompletely elucidated. This integrative perspective article synthesizes the cumulative role of gene-environment interaction in the pathophysiology of T1D. Genetics plays a significant role in T1D susceptibility, particularly at the major histocompatibility complex (MHC) locus and cathepsin H (CTSH) locus. In addition to genetics, environmental factors such as viral infections, pesticide exposure, and changes in the gut microbiome have been associated with the development of T1D. Alterations in the gut microbiome impact mucosal integrity and immune tolerance, increasing gut permeability through molecular mimicry and modulation of the gut immune system, thereby increasing the risk of T1D potentially through the induction of autoimmunity. HLA class II haplotypes with known effects on T1D incidence may directly correlate to changes in the gut microbiome, but precisely how the genes influence changes in the gut microbiome, and how these changes provoke T1D, requires further investigations. These gene-environment interactions are hypothesized to increase susceptibility to T1D through epigenetic changes such as DNA methylation and histone modification, which in turn modify gene expression. There is a need to determine the efficacy of new interventions that target these epigenetic modifications such as "epidrugs", which will provide novel avenues for the effective management of T1D leading to improved quality of life of affected individuals and their families/caregivers.

A systematic review of the association of Type I diabetes with sensorineural hearing loss.

OBJECTIVES: Type 1 diabetes (T1D) has been associated with several comorbidities such as ocular, renal, and cardiovascular complications. However, the effect of T1D on the auditory system and sensorineural hearing loss (SNHL) is still not clear. The aim of this study was to conduct a systematic review to evaluate whether T1D is associated with hearing impairment. METHODS: The databases PubMed, Science Direct, Scopus, and EMBASE were searched in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. Three reviewers independently screened, selected, and extracted data. The Joanna Briggs Institute (JBI) Critical Appraisal Tools for Analytical cross-sectional and case-control studies were used to perform quality assessment and risk of bias analysis on eligible studies. RESULTS: After screening a total of 463 studies, 11 eligible original articles were included in the review to analyze the effects of T1D on the auditory system. The included studies comprised cross-sectional and case-control investigations. A total of 5,792 patients were evaluated across the 11 articles included. The majority of the studies showed that T1D was associated with hearing impairment compared to controls, including differences in PTAs and OAEs, increased mean hearing thresholds, altered acoustic reflex thresholds, and problems with the medial olivocochlear (MOC) reflex inhibitory effect. Significant risk factors included older age, increased disease duration, and higher HbA1C levels. CONCLUSIONS: This systematic review suggests that there is a correlation between T1D and impairment on the auditory system. A multidisciplinary collaboration between endocrinologists, otolaryngologists, and audiologists will lead to early detection of hearing impairment in people with T1D resulting in early intervention and better clinical outcomes in pursuit of improving the quality of life of affected individuals. REGISTRATION: This systematic review is registered in PROSPERO (CRD42023438576).

Impact of GAD65 and IA2 autoantibodies on islet allograft survival.

Introduction: Islet transplantation (ITx) shows promise in treating T1D, but the role of islet autoantibodies on graft survival has not been clearly elucidated. We aimed to analyze the effect of GAD65 and IA2 autoantibody status on graft survival and attainment of insulin independence in subjects with T1D who underwent ITx. Method: We conducted a retrospective cohort study on 47 ITx recipients from 2000 to 2018. Islet infusion was performed via intrahepatic portal (n=44) or onto the omentum via laparoscopic approach (n=3). Immunosuppression involved anti-IL2 receptor antibody, anti-TNF, and dual combinations of sirolimus, tacrolimus, or mycophenolate mofetil (Edmonton-like) in 38 subjects (80.9%). T-cell depletion induction with Edmonton-like maintenance was used in 9 subjects (19%). GAD65 and IA2 autoantibodies were assessed pre-transplant and post-transplant (monthly) until graft failure, and categorized as persistently negative, persistently positive, or seroconverters. Graft survival was analyzed using U-Mann-Whitney test, and Quade's nonparametric ANCOVA adjusted for confounders. Kaplan-Meier and Log-Rank tests were employed to analyze attainment of insulin independence. P value <0.05 indicated statistical significance. Results: ITx recipients with persistent autoantibody negativity (n = 21) showed longer graft function (98 [61 - 182] months) than those with persistent autoantibody positivity (n = 18; 38 [13 - 163] months), even after adjusting for immunosuppressive induction protocol (P = 0.027). Seroconverters (n=8) had a median graft survival time of 73 (7.7 - 167) months, which did not significantly differ from the other 2 groups. Subjects with persistently single antibody positivity to GAD65 (n = 8) had shorter graft survival compared to negative islet autoantibody (GAD65/IA2) subjects (n = 21; P = 0.016). Time of graft survival did not differ in subjects with single antibody positivity to IA2. The proportion of insulin independence attainment was similar irrespective of autoantibody status. Conclusion: The persistence of islet autoantibodies, as markers of islet autoimmunity, may represent an underappreciated contributing factor to the failure of transplanted ß cells. Whether induction with T-cell depletion may lead to improved graft survival, independent of islet autoantibody status, could not be evaluated in our cohort. Larger prospective studies are needed to further address the role of islet autoantibody status on islet graft survival.

Eyes on the Prize: Decoding the Ophthalmic Product Regulations and Intricacies of the U.S. Food and Drug Administration Approval.

The dynamic and continuously evolving field of ophthalmology necessitates rigorous regulatory oversight in the United States. This review outlines the multifaceted Food and Drug Administration's (FDA) approval process for ophthalmic products, detailing the classifications, pathways, and regulatory compliance for devices, drugs, biologics, and combination products. Particular emphasis is placed on distinct frameworks for Class I, II, and III devices, as well as regulations for drugs, biologics, and combination products. The organizational structure of the FDA is detailed, with highlights on specific Ophthalmology oversight divisions, historical regulatory evolution, and initiatives such as Patient-Focused Drug Development. An in-depth examination of the regulatory journey, ranging from initial research to post-marketing surveillance, includes practical guidance through stages such as Pre-Investigational New Drug/Pre-Submission consultations, clinical trials, new drug application/biologics license application/premarket approval submissions, and FDA advisory committee interactions. The article underscores the importance of early interactions with the health authorities, interdisciplinary team collaboration, adherence to current standards, and the anticipation of policy changes to ensure patient safety. It concludes with an analysis of 4 key FDA-approved ophthalmic products, including Eylea®, Luxturna®, Alphagan P®, and the Raindrop® Near Vision Inlay, detailing their contributions to ophthalmic care and offering valuable insights into their respective clinical trials, regulatory pathways, and potential implications. These case studies are included to illustrate both successful and failed ophthalmic product launches, thereby highlighting the importance of alignment with regulatory compliance.

HLA-B Matching Prolongs Allograft Survival in Islet Cell Transplantation.

Islet cell transplantation (ITx) is an effective therapeutic approach for selected patients with type 1 diabetes with hypoglycemia unawareness and severe hypoglycemia events. In organ transplantation, human leukocyte antigen (HLA) mismatching between donor and recipient negatively impacts transplant outcomes. We aimed to determine whether HLA matching has an impact on islet allograft survival. Forty-eight patients were followed up after islet transplantation at our institution from 2000 to 2020 in a retrospective cohort. Patients underwent intrahepatic ITx or laparoscopic omental approach. Immunosuppression was dependent upon the protocol. We analyzed HLA data restricted to A, B, and DR loci on allograft survival using survival and subsequent multivariable analyses. Patients were aged 42.8 ± 8.4 years, and 64.3% were female. Diabetes duration was 28.6 ± 11.6 years. Patients matching all three HLA loci presented longer graft survival (P = 0.030). Patients with ≥1 HLA-B matching had longer graft survival compared with zero matching (P = 0.025). The number of HLA-B matching was positively associated with time of graft survival (Spearman's rho = 0.590; P = 0.034). Analyses adjusted for confounders showed that ≥1 matching for HLA-B decreased the risk of allograft failure (P = 0.009). Our data suggest that HLA-B matching between recipients and donors improved islet allograft survival. Matching all three HLA loci (A, B, and DR) was also associated with prolonged islet allograft survival. Prospective studies and a larger sample size are warranted to validate our findings.

Immunological and virological triggers of type 1 diabetes: insights and implications.

Type 1 diabetes (T1D) is caused by an autoimmune process which culminates in the destruction of insulin-producing beta cells in the pancreas. It is widely believed that a complex and multifactorial interplay between genetic and environmental factors, such as viruses, play a crucial role in the development of the disease. Research over the past few decades has shown that there is not one single viral culprit, nor one single genetic pathway, causing the disease. Rather, viral infections, most notably enteroviruses (EV), appear to accelerate the autoimmune process leading to T1D and are often seen as a precipitator of clinical diagnosis. In support of this hypothesis, the use of anti-viral drugs has recently shown efficacy in preserving beta cell function after onset of diabetes. In this review, we will discuss the various pathways that viral infections utilize to accelerate the development of T1D. There are three key mechanisms linking viral infections to beta-cell death: One is modulated by the direct infection of islets by viruses, resulting in their impaired function, another occurs in a more indirect fashion, by modulating the immune system, and the third is caused by heightened stress on the beta-cell by interferon-mediated increase of insulin resistance. The first two aspects are surprisingly difficult to study, in the case of the former, because there are still many questions about how viruses might persist for longer time periods. In the latter, indirect/immune case, viruses might impact immunity as a hit-and-run scenario, meaning that many or all direct viral footprints quickly vanish, while changes imprinted upon the immune system and the anti-islet autoimmune response persist. Given the fact that viruses are often associated with the precipitation of clinical autoimmunity, there are concerns regarding the impact of the recent global coronavirus-2019 (COVID-19) pandemic on the development of autoimmune disease. The long-term effects of COVID-19 infection on T1D will therefore be discussed, including the increased development of new cases of T1D. Understanding the interplay between viral infections and autoimmunity is crucial for advancing our knowledge in this field and developing targeted therapeutic interventions. In this review we will examine the intricate relationship between viral infections and autoimmunity and discuss potential considerations for prevention and treatment strategies.

Population wide testing pooling strategy for SARS-CoV-2 detection using saliva.

SARS-CoV-2 pandemic has forced frequent testing of populations. It is necessary to identify the most cost-effective strategies for the detection of COVID-19 outbreaks. Nasopharyngeal samples have been used for SARS-CoV-2 detection but require a healthcare professional to collect the sample and cause discomfort and pain to the individual. Saliva has been suggested as an appropriate fluid for the diagnosis of COVID-19. We have investigated the possibility of using pools of saliva samples to detect SARS-CoV-2 in symptomatic and asymptomatic patients. Two hundred and seventy-nine saliva samples were analyzed through RT-PCR of Envelope, Nucleocapsid and Open Reading Frame 1ab genes. Reproducibility assays showed an almost perfect agreement as well as high sensitivity (96.6%), specificity (96.8%), positive predicted value (96.6%), and negative predicted value (96.8%). The average Cycle Threshold of the genes detected was 29.7. No significant differences (p > 0.05) were detected when comparing the cycle threshold average of two consecutive reactions on the same positive saliva samples. Saliva samples have a higher median viral load (32.6) than in nasopharyngeal samples (28.9), although no significant differences were detected (p > 0.05). Saliva-pool samples allowed effective SARS-CoV-2 screening, with a higher sensibility (96.9%) on 10-sample pools than in 20-sample pools (87.5%). Regardless of pools size specificity was high (99.9%) and an almost perfect agreement was observed. Our strategy was successfully applied in population wide testing of more than 2000 individuals, showing that it is possible to use pooled saliva as diagnostic fluid for SARS-CoV-2 infection.

Prolonged Islet Allograft Function is Associated With Female Sex in Patients After Islet Transplantation.

BACKGROUND: Islet transplantation (ITx) has proved to be effective in preventing severe hypoglycemia and improving metabolic control in selected subjects with type 1 diabetes. Long-term graft function remains a challenge. Estrogens have been shown to protect ß cells from metabolic stresses and improve revascularization of transplanted human islets in the mouse. We aimed to evaluate the influence of sex in allograft survival of ITx recipients. METHODS: We analyzed a retrospective cohort of ITx recipients (n = 56) followed-up for up to 20 years. Allograft failure was defined as a stimulated C-peptide <0.3 ng/mL during a mixed-meal tolerance test. Subjects were divided into recipients of at least 1 female donor (group 1) and recipients of male donors only (group 2). RESULTS: Group 1 subjects (n = 25) were aged 41.5 ± 8.4 years and group 2 subjects (n = 22) 45.9 ± 7.3 years (P = 0.062). Female recipient frequency was 44.8% (n = 13) in group 1 and 55.2% (n = 16) in group 2 (P = 0.145). Group 2 developed graft failure earlier than group 1 (680 [286-1624] vs 1906 [756-3256] days, P = 0.038). We performed additional analyses on female recipients only from each group (group 1, n = 16; group 2, n = 20). Female recipients in group 1 exhibited prolonged allograft function compared with group 2, after adjustment for confounders (odds ratio, 28.6; 95% CI, 1.3-619.1; P < 0.05). CONCLUSION: Recipients of islets from at least 1 female donor exhibited prolonged graft survival compared with recipients of islets from exclusively male donors. In addition, female recipients exhibited prolonged survival compared with male recipients following ITx of at least 1 female donor.

Long-term Persistence of Allosensitization After Islet Allograft Failure.

BACKGROUND: Allosensitization has been reported after discontinuation of immunosuppression following graft failure in islet transplantation (ITx) recipients, though duration of its persistence is unknown. METHODS: We evaluated 35 patients with type 1 diabetes who received ITx, including 17 who developed graft failure (ITx alone, n = 13; ITx plus bone marrow-derived hematopoietic stem cells, n = 4) and 18 with persistent graft function. Panel-reactive antibody (PRA) was measured yearly for the duration of graft function within 1 y after graft failure at enrollment and yearly thereafter. RESULTS: In ITx alone graft failure patients, 61% (8/13) were PRA-positive at 6 y postgraft failure, and 46% (6/13) developed donor-specific anti-HLA antibodies (DSA to 2 ± 1 donors) during follow-up. The degree of sensitization was variable (cPRA ranging between 22% and 100% after graft failure). Allosensitization persisted for 7-15 y. Three subjects (3/13) were not allosensitized. In ITx plus bone marrow-derived hematopoietic stem cell recipients, cPRA-positivity (88%-98%) and DSA positivity persisted for 15 y in 75% (3/4) of subjects. CONCLUSIONS: Allosensitization was minimal while subjects remained on immunosuppression, but after discontinuation of immunosuppressive therapy, the majority of subjects (77%) became allosensitized with persistence of PRA positivity for up to 15 y. Persistence of allosensitization in this patient population is of clinical importance as it may result in longer transplant waiting list times for identification of a suitable donor in the case of requiring a subsequent transplant.

Cryptogenic Stroke and Valvular Strands.

BACKGROUND: Ischaemic stroke can be classified according to its aetiology. In cryptogenic stroke, Lambl's excrescences should be considered since they can only be detected through transesophageal echocardiography (TEE), which is not routinely performed. CASE DESCRIPTION: The authors report the case of a 63-year-old Caucasian man with two ischaemic cerebral events associated with the presence of Lambl's excrescences in the aortic valve detected with TEE. Switching antiaggregant therapy to anticoagulant therapy allowed the patient to remain asymptomatic throughout a 3-year follow-up. CONCLUSION: The lack of protocols for the management of cryptogenic stroke results in a delay in the identification of less frequent causes of stroke, leading to recurrent vascular events, morbidity and loss of functionality. The authors describe a patient who experienced multiple cerebral ischaemic events until the correct diagnosis was made. LEARNING POINTS: Lambl's excrescences are a considered a rare cause of embolic stroke, probably because they are underdiagnosed.The pathophysiology is not fully understood, making therapeutic decisions difficult.Early recognition and management of this structural valve disease can prevent life-threatening complications.

Lithium, an old friend and a forgotten enemy.

INTRODUCTION: Nephrogenic diabetes insipidus (DI) is a polyuric and polydipsic syndrome and can have multiple causing factors. CASE DESCRIPTION: A 69-year-old woman with bipolar disorder medicated with lithium 400mg for 12 years on a daily basis. The patient was admitted, after psychiatric decompensation, with hypernatremia unresponsive to hypotonic iv fluids. The diagnosis of DI was made with high plasmatic osmolality measurement, low urine osmolality, and high levels of antidiuretic hormone. Full clinical recovery was possible with lithium suspension, hydration, and chlorthalidone. DISCUSSION: Although frequently used in the past, Lithium (Li) is nowadays rarely used in clinical practice for prolonged treatments because of its potentially devastating side effects. Clinicians must be aware of those side effects in order to prevent organ damage, mainly in patients with severe bipolar disease and precarious response to alternative treatments.

Lithium, an old friend and a forgotten enemy

SUMMARY INTRODUCTION: Nephrogenic diabetes insipidus (DI) is a polyuric and polydipsic syndrome and can have multiple causing factors. CASE DESCRIPTION: A 69-year-old woman with bipolar disorder medicated with lithium 400mg for 12 years on a daily basis. The patient was admitted, after psychiatric decompensation, with hypernatremia unresponsive to hypotonic iv fluids. The diagnosis of DI was made with high plasmatic osmolality measurement, low urine osmolality, and high levels of antidiuretic hormone. Full clinical recovery was possible with lithium suspension, hydration, and chlorthalidone. DISCUSSION: Although frequently used in the past, Lithium (Li) is nowadays rarely used in clinical practice for prolonged treatments because of its potentially devastating side effects. Clinicians must be aware of those side effects in order to prevent organ damage, mainly in patients with severe bipolar disease and precarious response to alternative treatments.

RESUMO INTRODUÇÃO: O diabetes insípido nefrogênico faz parte das síndromes poliúricas polidipsicas e pode ter múltiplos fatores causais. CASO CLÍNICO: Mulher de 69 anos, com doença bipolar medicada com lítio 400 mg por dia durante 12 anos. A doente foi internada, após descompensação da doença bipolar, por hipernatremia não responsiva a fluidoterapia hipotônica endovenosa. O diagnóstico de DI foi realizado com base na elevação da osmolaridade plasmática, baixa osmolaridade urinária e níveis elevados de hormona antidiurética. Verificou-se recuperação clínica completa com suspensão do lítio, hidratação e clorotalidona. DISCUSSÃO: Apesar do seu uso frequente no passado, o lítio (Li) é hoje em dia raramente utilizado na prática clínica por períodos prolongados pelos seus efeitos potencialmente devastadores. Os médicos devem ter em conta os potenciais efeitos secundários de forma a prevenir lesão de órgão em doentes com doença bipolar de difícil controle com outra terapêutica.

Long-Term Self-Expandable Metal Stent (SEMS) for Esophageal Variceal Bleeding: A Picture of the Natural History.

INTRODUCTION: We aim to discuss the utility of self-expandable esophageal metal stent (SEMS) in variceal bleeding in challenging cases. METHODS: Case description, discussion on patient management and decision-making process in an uncommon situation, from a multidisciplinary point of view. RESULTS: We report a case of a cirrhotic patient with refractory variceal bleeding who underwent a SEMS placement, which remained in situ for 9 months. This decision was based on the initial poor status and short life expectancy, limiting the consideration of other options for lowering portal hypertension, along with an underlying prothrombotic predisposition. However, the patient's general and hepatic improvement and the development of dysphagia led to the SEMS removal, exposing a large esophageal-tracheal fistula. DISCUSSION: Early patient evaluation, risks of long-term SEMS, and life expectancy should be taken in consideration before SEMS placement.

Avaliação do estado nutricional e pressão arterial de adolescentes / Nutritional status assessment and blood pressure in adolescents

Introdução: O excesso de peso associa-se ao desenvolvimento de hipertensão arterial sistêmica independentemente da faixa etária. Portanto, objetivou-se verificar a associação entre estado nutricional e nível de pressão arterial em adolescentes. Método: Estudo transversal, realizado entre fevereiro e abril de 2013, com amostra constituída por 85 adolescentes, com idade entre 10 e 19 anos. A coleta de dados foi constituída pela aferição do peso, altura, índice de massa corporal, circunferência da cintura, pressão arterial e aplicação de um questionário estruturado, com questões sobre as condições socioeconômicas e o hábito alimentar. Resultados: A amostra foi composta por 52% (n=44) de adolescentes do gênero feminino e a média de idade foi de 14,05±1,48 anos. Na análise dos dados antropométricos, observou-se diferença estatisticamente significativa no grupo dos meninos nas variáveis de peso, altura e circunferência da cintura, quando comparados ao grupo das meninas. Na avaliação dos hábitos alimentares, verificou-se que o grupo dos meninos referiu consumir refrigerante diariamente e o grupo das meninas referiu nunca consumir (p=0,033). Não houve correlação significativamente estatística entre a classificação do índice de massa corporal e os níveis pressóricos (r=0,032; p=0,774). Verificou-se correlação entre índice de massa corporal e circunferência da cintura (r=0,581; p=<0,001). Conclusões: Foram encontradas diferenças estatisticamente significativas entre os grupos, houve diferença no grupo dos meninos nas variáveis de peso, altura, circunferência da cintura e consumo de refrigerantes, quando comparados ao grupo das meninas.(AU)

Introduction: Overweight is associated with the development of systemic arterial hypertension independently of the age group. Therefore, it was aimed to evaluate the association between nutritional status and blood pressure in adolescents. Methods: A cross-sectional study was conducted between February and April 2013, with a sample consisting of 85 adolescents aged between 10 and 19 years. Participants were assessed for weight and height to calculate body mass index, waist circumference and blood pressure. In addition, participants answered a structured questionnaire about socioeconomic conditions and feeding habits. Results: Fifty-two percent of the participants were females and the mean age was 14.05±1.48 years. Analysis of anthropometric data showed that weight, height and waist circumference were significantly higher in male participants than in females. In the evaluation of dietary habits, it was found that the male group reported consuming soft drinks daily, while the female group reported no consumption of this kind of beverage (p=0.033). No significant statistical correlation was observed between the classification of body mass index and blood pressure levels (r=0.032; p=0.774). There was a good correlation between body mass index and waist circumference (r=0.581; p=0.001). Conclusions: Statistically significant differences were observed between the groups, with higher levels in the variables weight, height, waist circumference and soft drink consumption in boys, when compared to the group of girls.(AU)

Alimentação na escola e estado nutricional de estudantes do ensino fundamental / Feeding in school and nutritional status of elementary school students / Alimentación en la escuela y el estado nutricional de Estudiantes de la enseñanza fundamental

Objetivo: Relacionar o estado nutricional e o sexo de estudantes do ensino fundamental ao consumo da alimentação escolar gratuita, comprada nas cantinas e trazida de casa. Métodos: Estudo observacional, transversal, realizado em 2013 com 120 estudantes do 5° ao 9° ano de duas escolas municipais de ensino fundamental de um município gaúcho. Aplicou-se questionário estruturado para investigação acerca da alimentação escolar gratuita, comprada na escola ou trazida de casa. Foram aferidos peso, altura e circunferência da cintura (CC). Analisou-se a distribuição dos percentis do índice de massa corporal (IMC) e classificou-se o estado nutricional utilizando-se o Teste Exato de Fisher para análise. Resultados: Estudantes do sexo feminino (n=36; 46,8%) referiram não consumir a alimentação escolar gratuita porque não gostam, e os estudantes do sexo masculino (n=22; 51,2%), porque não sentem fome (p=0,028). Com relação à alimentação comprada na escola, a preferência feminina (n=12; 27,9%) foi por guloseimas, e a masculina (n=21; 48,8%), por cachorro quente (p=<0,001). A maioria dos estudantes classificados como eutróficos (n=28; 33,3%) consumia a alimentação porque sentia fome, e os com sobrepeso/obesidade (n=24; 70,6%), porque a considerava saudável e nutritiva (p=0,028). Conclusão: Os estudantes eutróficos, com sobrepeso e obesidade de ambos os sexos consomem de 2 a 3 refeições gratuitas oferecidas na escola por semana e demonstram preferência por trazer de casa bolachas, salgadinhos e sanduíches com pão branco. O sexo feminino prefere refrigerantes, guloseimas, doces e bolos, enquanto o sexo masculino, cachorro quente.

Objective: To relate the nutritional status and sex of elementary students with the intake of free school meals, meals bought at canteens and meals brought from home. Methods: Cross-sectional observational study performed in 2013 with 120 students from 5th to 9th grade of two elementary and public school of a municipality in Rio Grande do Sul. A structured questionnaire was applied to investigate free school meals, meals purchased at school or brought from home. Weight, height and waist circumference (WC) were measured. The distribution of percentiles of Body Mass Index (BMI) was analyzed and the nutritional status was ranked, using the Fisher?s Exact Test for analysis. Results: Female students (n=36; 46.8%) reported not consuming the free school meals because they dislike it, and male students (n=22; 51.2%) because they do not feel hungry (p=0.028). Regarding the food purchased at school, females? preference (n=12; 27.9%) was for candies and males? (n=21; 48.8%) was for hot dog (p=<0.001). The majority of the students classified as eutrophic (n=28; 33.3%) consumed the food because they were hungry, and those classified as overweight/obese (n=24; 70.6%), because they considered it healthy and nutritious (p=0.028). Conclusion: Most eutrophic, overweight and obese students in both genders consume 2-3 free meals offered at school per week and they give preference to bringing from home some biscuits, snacks and sandwiches made with white bread. Females prefer soft drinks, goodies, candies, and cakes, while males prefer the hot dog.

Objetivo: Relacionar el estado nutricional y el sexo de Estudiantes de la enseñanza fundamental con el consumo de la alimentación gratuita de la escuela, la de las cafeterías de la escuela y las que se trae de casa. Métodos: Estudio observacional y transversal realizado en 2013 con 120 estudiantes del 5° al 9° año de dos escuelas municipales de enseñanza fundamental de un município del Sur de Brasil. Se aplicó un cuestionario estructurado para investigar sobre la alimentación gratuita de la escuela, aquella comprada en la cafetería o la que se trae de casa. Fueron verificados el peso, la altura y circunferencia de la cintura (CC). Se analizó la distribución de los percentiles del índice de masa corporal (IMC) y se clasificó el estado nutricional utilizándose la prueba Exacto de Fisher. Resultados: Estudiantes Del sexo femenino (n=36; 46,8%) refirieron que no consumían La alimentación gratuita de la escuela porque no les gustan y los estudiantes del sexo masculino (n=22; 51,2%) porque no tienen hambre (p=0,028). Respecto la alimentación adquirida en La escuela la preferencia femenina (n=12; 27,9%) fue por golosinas y la masculina (n=21; 48,8%) por perrito caliente (p=<0,001). La mayoría de los estudiantes clasificados como eutróficos (n=28; 33,3%) consumían la alimentación porque tenían hambre y aquellos con sobrepeso/obesidad (n=24; 70,6%) porque La consideraba saludable y nutritiva (p=0,028). Conclusión: Los estudiantes eutróficos de ambos sexos con sobrepeso y obesidad consumen entre 2 y 3 comidas gratuitas ofrecidas en la escuela cada semana y demuestran la preferencia de traer de casa galletas, ganchitos y emparedados de pan blanco. El sexo femenino prefiere refrescos, golosinas, dulces y pasteles mientras el sexo masculino prefiere el perrito caliente.

Variação na prevalência de risco nutricional em indivíduos hospitalizados conforme cinco protocolos de triagem nutricional / Variation in the prevalence of nutritional risk in hospitalized individuals according to five nutritional screening protocols

Objetivos: Verificar a prevalência de risco nutricional em indivíduos hospitalizados e a concordância no diagnóstico nutricional através de cinco protocolos de triagem nutricional.Métodos: Um estudo transversal incluiu pacientes de ambos os gêneros, maiores de 18 anos, admitidos no hospital no período de janeiro a março de 2013. Dentro das primeiras 48 horas de internação, foram aplicados os seguintes protocolos de triagem nutricional: Mini Nutrition Assessment (MNA); Mini Nutrition Assessment Short Form (MNA-SF); Subjective Global Assessment (ASG); Nutritional Risk Screening (NRS 2002); e Malnutrition Universal Screening Tool (MUST). Os protocolos são compostos de questões relacionadas à perda de peso, índice de massa corporal, capacidade funcional, inapetência alimentar e alterações gastrintestinais. Os indivíduos foram classificados em dois níveis: bem nutridos e desnutridos.Resultados: Foi avaliada uma amostra de 100 pacientes, que evidenciou 49 (49%) indivíduos com risco nutricional pelo protocolo MNA; 53 (53%) pelo MNA-SF; 23 (23%) pelo MUST; 7 (7%) pelo NRS; e 4 (4%) pelo ASG. O gênero feminino e idades superiores a 60 anos prevaleceram na amostra. Três dos protocolos, MNA-SF, MUST e NRS, detectaram maior risco nutricional em pacientes com mais de 60 anos (p≤0,05). Observou-se que MNA e MNA-SF foram os protocolos que obtiveram melhor concordância (coeficiente Kappa=0,760, p<0,001).Conclusões: Houve boa concordância entre os protocolos de MNA e MNA-SF, porém não destes com os demais protocolos, que também não apresentaram concordância entre si. O protocolo que classificou a maior porcentagem de pacientes com risco nutricional foi o MNA-SF, e o que menos detectou risco nutricional foi o ASG...

AIMS: To assess the prevalence of nutritional risk in hospitalized subjects and the agreement in nutritional diagnosis between five nutritional screening protocols.METHODS: A cross-sectional study included patients of both genders, aged 18, admitted to hospital from January to March 2013 Within the first 48 hours of admission, the following nutritional screening protocols were applied: Mini Nutrition Assessment (MNA); Mini Nutrition Assessment Short Form (MNA-S); Subjective Global Assessment (ASG); Nutritional Risk Screening (NRS 2002); and Malnutrition Universal Screening Tool (MUST). The protocols consist of questions related to weight loss, body mass index, functional capacity, food appetite and gastrointestinal disturbances. Subjects were classified into two levels: well-nourished and malnourished.RESULTS: A sample of 100 patients were evaluated, which showed 49 (49%) individuals at nutritional risk by the MNA protocol; 53 (53%) by MNA-SF; 23 (23%) by MUST; 7 (7%) by NRS; and 4 (4%) by ASG. The female and aged over 60 years prevailed in the sample. Three protocols, MNA-SF, MUST and NRS, showed a higher nutritional risk in patients over 60 years (p equal or less than 0.05). It was observed that MNA and MNA-SF protocols obtained better agreement (Kappa coefficient = 0.760, p less than 0.001).CONCLUSIONS: There was good agreement between the protocols MNA and MNA-SF, but not of those with other protocols, which also showed no correlation with each other. The protocol that ranked the highest percentage of patients at nutritional risk was the MNA-SF, and less nutritional risk was detected by ASG...

Preclinical imaging: an essential ally in modern biosciences.

Translational research is changing the practice of modern medicine and the way in which health problems are approached and solved. The use of small-animal models in basic and preclinical sciences is a major keystone for these kinds of research and development strategies, representing a bridge between discoveries at the molecular level and clinical implementation in diagnostics and/or therapeutics. The development of high-resolution in vivo imaging technologies provides a unique opportunity for studying disease in real time, in a quantitative way, at the molecular level, along with the ability to repeatedly and non-invasively monitor disease progression or response to treatment. The greatest advantages of preclinical imaging techniques include the reduction of biological variability and the opportunity to acquire, in continuity, an impressive amount of unique information (without interfering with the biological process under study) in distinct forms, repeated or modulated as needed, along with the substantial reduction in the number of animals required for a particular study, fully complying with 3R (Replacement, Reduction and Refinement) policies. The most suitable modalities for small-animal in vivo imaging applications are based on nuclear medicine techniques (essentially, positron emission tomography [PET] and single photon emission computed tomography [SPECT]), optical imaging (OI), computed tomography (CT), magnetic resonance imaging (MRI), magnetic resonance spectroscopy imaging (MRSI), and ultrasound. Each modality has intrinsic advantages and limitations. More recently, aiming to overcome the inherent limitations of each imaging modality, multimodality devices designed to provide complementary information upon the pathophysiological process under study have gained popularity. The combination of high-resolution modalities, like micro-CT or micro-MRI, with highly sensitive techniques providing functional information, such as micro-PET or micro-SPECT, will continue to broaden the horizons of research in such key areas as infection, oncology, cardiology, and neurology, contributing not only to the understanding of the underlying mechanisms of disease, but also providing efficient and unique tools for evaluating new chemical entities and candidate drugs. The added value of small-animal imaging techniques has driven their increasing use by pharmaceutical companies, contract research organizations, and research institutions.

Evaluation of metabolic syndrome and associations with inflammation and graft function in renal transplant recipients / Avaliação da síndrome metabólica e suas associações com inflamação e função do enxerto em pacientes receptores de transplante renal

INTRODUCTION: Cardiovascular disease (CVD) is a major determinant of mortality in renal transplant recipients (RTR). Metabolic syndrome (MS) and chronic inflammation are currently considered non traditional risk factors for cardiovascular disease. This study evaluates the frequency of these conditions their associations with graft function. OBJECTIVE: To evaluate the prevalence of metabolic syndrome (MS) and inflammation and their associations with graft function in renal transplant recipients. METHODS: A cross-sectional study was carried out with 200 RTR. MS was defined by the NCEP-ATP III criteria. Inflammation was assessed by CRP levels. Renal function was assessed by GFR estimation using the MDRD equation. RESULTS: MS occurred in 71 patients (35.5%). Patients with MS had higher CPR and decreased GFR levels. Inflammation was present in 99 patients (49.5%). Mean waist perimeter, body mass index, triglycerides and serum total cholesterol were significantly higher in inflamed patients. An association between MS and inflammation was demonstrated, 48 (67.6%) patients with MS were inflamed and among those without MS the rate of inflamed patients was 39.5% (51 patients) (p < 0.001). A significantly higher percentage of patients with MS in the group of patients in chronic renal disease stages III and IV was observed. CONCLUSION: In RTR there is a significant association among MS and inflammation. MS is negatively associated with graft function. The clinical implications of these findings must be evaluated in longitudinal studies.

INTRODUÇÃO: A doença cardiovascular (DCV) é um dos principais determinantes da mortalidade em receptores de transplante renal (RTR). A síndrome metabólica (SM) e a inflamação crônica atualmente são considerados fatores de risco não tradicionais para doença cardiovascular. OBJETIVO: Avaliar a frequência da SM e da inflamação e suas associações com a função do enxerto em receptores de transplante renal. MÉTODOS: Foi realizado um estudo transversal com 200 RTR. A SM foi definida pelos critérios do NCEP-ATP III. A inflamação foi avaliada por meio dos níveis de PCR. A função renal foi avaliada pela estimativa da TFG por meio da equação MDRD. RESULTADOS: A SM ocorreu em 71 pacientes (35,5%). Pacientes com SM apresentaram maior PCR e diminuição dos níveis de TFG. A inflamação esteve presente em 99 pacientes (49,5%). A circunferência abdominal, índice de massa corporal, triglicérides e colesterol total foram significativamente maiores em pacientes com inflamação. Foi demonstrada associação entre MS e inflamação, 48 (67,6%) pacientes com SM estavam inflamados e entre aqueles sem SM a taxa de inflamados foi de 39,5% (51 pacientes) (p < 0,001). Uma porcentagem significativamente maior de pacientes com SM foi observada no grupo de pacientes de doença renal crônica estágios III e IV. CONCLUSÃO: Em RTR há associação significativa entre MS e inflamação. A SM está negativamente associada com a função do enxerto. As implicações clínicas destes achados devem ser avaliadas em estudos longitudinais.