Efficacy and safety of Obex® in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: Obex® may be helpful in reducing body weight and fat. The current study was carried out to evaluate the efficacy and safety of Obex® in the treatment of overweight and obese subjects. METHODS: A double-blind, randomised, controlled phase III clinical trial was conducted involving 160 overweight and obese subjects (BMI ≥ 25.0 and < 40 kg/m2) aged 20 to 60 years, who received Obex® (n = 80) and placebo (n = 80) plus non-pharmacological treatment (physical activity and nutritional counseling). One sachet of Obex® or placebo were administered before the two main meals each day for 6 months. In addition to anthropometric measurements and blood pressure, fasting plasma and 2 h glucose levels during the oral glucose tolerance test, lipid profile, insulin, liver enzymes, creatinine, and uric acid (UA) were determined, insulin resistance (HOMA-IR) beta-cell function (HOMA-ß) were assessed and insulin sensitivity (IS) was calculated with three indirect indexes. RESULTS: After 3 months of Obex®, 48.3% of the participants (28/58) achieved complete success in reducing both weight and waist circumference by greater than or equal to 5% from baseline, as opposed to 26.0% (13/50) of individuals receiving placebo (p = 0.022). Compared to baseline, at 6 months no differences were found between the groups concerning anthropometric and biochemical measurements, except for high-density lipoprotein cholesterol (HDL-c) levels, which were higher in subjects receiving Obex® compared to those receiving placebo (p = 0.030). After 6 months of treatment, both groups showed reduced cholesterol and triglyceride levels (p < 0.012) compared to baseline value. However, only those intake Obex® showed reduced insulin concentrations and HOMA-IR, improved IS (p < 0.05), and decreased creatinine and UA levels (p < 0.005). CONCLUSIONS: The consumption of Obex® together with lifestyle changes increased HDL-c, contributed to a rapid reduction of weight and waist circumference, as well as improved insulin homeostasis, which did not occur in the placebo group, and appears to be safe as an adjunct at conventional obesity treatment. TRIAL REGISTRATION: Clinical trial protocol was registered in the Cuban public registry of clinical trials under code RPCEC00000267 on 17/04/2018 and also registered in the international registry of clinical trials, ClinicalTrials.gov, under code: NCT03541005 on 30/05/2018.

An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes.

We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels, and stimulated C-peptide were observed between the Itolizumab and placebo groups at 52 weeks. A significant decrease in stimulated C-peptide was observed during the follow-up period (p = 0.012). One subject treated with 1.6 mg of Itolizumab showed a marked increase in the levels of stimulated C-peptide three years after completion of the trial. Taken together, this is the first study to demonstrate that combination treatment with Itolizumab and insulin is safe in humans and does not affect the residual function of beta cells up to 52 weeks. The findings from our study show preliminary evidence that high doses of Itolizumab could potentially arrest the loss of beta cell function in the long term. Further studies with a longer follow-up and larger numbers of patients are envisaged to assess the effect with high dose Itolizumab.

Utilidad del fenotipo hipertensión-obesidad abdominal para identificar personas con riesgo cardiovascular global moderado y alto / Use of the hypertension- abdominal obesity phenotype to identify people with moderate and high overall cardiovascular risk

Introducción: La obesidad está relacionada con un riesgo elevado de enfermedades no transmisibles. Una tendencia creciente en la prevalencia de la obesidad desde principios de la década de 1980 ha planteado una importante carga de salud de la población en todo el mundo. Objetivos: Determinar la utilidad del fenotipo hipertensión-obesidad abdominal para identificar personas con riesgo cardiovascular global moderado o alto en adultos con exceso de peso corporal y si esta es superior a la de otros binomios fenotípicos descritos y al síndrome metabólico. Métodos: Estudio observacional, descriptivo y transversal que incluyó 257 personas de 35 a 70 años. Variables estudiadas: edad, sexo, peso, talla, índice de masa corporal, circunferencia de la cintura, presión arterial, colesterol, triglicéridos, colesterol-HDL y glucemia en ayunas. Se determinó la presencia del síndrome metabólico según los criterios de la declaración provisional conjunta [Joint Interim Statement (JIS), siglas en inglés], además se estudiaron los fenotipos hipertensión-obesidad abdominal, hipertrigliceridemia-obesidad abdominal e hiperglucemia-obesidad abdominal. El riesgo cardiovascular global fue evaluado mediante las tablas de Gaziano. Resultados: El 81,7 por ciento (210/257) de los sujetos presentó el fenotipo hipertensión-obesidad abdominal y la frecuencia de riesgo cardiovascular moderado-alto fue de 28,0 por ciento (72/257). El fenotipo hipertensión-obesidad abdominal detectó la mayor proporción de sujetos con riesgo cardiovascular moderado-alto (64 de los 72); el riesgo cardiovascular moderado-alto estaba presente en la mayoría con este fenotipo (88,8 por ciento), diferente de aquellos sin el fenotipo (11,1 por ciento). La sensibilidad (88,9 por ciento) y el valor predictivo negativo (83,0 por ciento) muestran que el fenotipo hipertensión-obesidad abdominal es un binomio útil para detectar individuos con riesgo cardiovascular moderado-alto. Conclusiones: La utilidad del fenotipo hipertensión-obesidad abdominal es superior a la de otros binomios fenotípicos y al síndrome metabólico para identificar personas con riesgo cardiovascular moderado-alto. La elevada sensibilidad y el alto valor predictivo negativo del fenotipo hipertensión-obesidad abdominal, así como la simplicidad de su determinación, lo convierten en una buena opción para pesquisar sujetos con este riesgo(AU)

Introduction: Obesity is linked to a high risk of non-communicable diseases. A growing trend in the prevalence of obesity since the early 1980s has posed a significant population´s health burden worldwide. Objectives: Determine the usefulness of the hypertension- abdominal obesity´s phenotype to identify cases with moderate or high overall cardiovascular risk in adults with excess body weight and whether it is superior to that of other phenotypic binomials described and to the metabolic syndrome. Methods: Observational, descriptive and cross-sectional study that included 257 people from 35 to 70 years old. Variables studied: age, sex, weight, size, body mass index, waist circumference, blood pressure, cholesterol, triglycerides, HDL cholesterol and fasting blood glucose. The presence of metabolic syndrome was determined according to the criteria of the Joint Interim Statement (JIS), and hypertension- abdominal obesity phenotypes, abdominal hypertriglyceridemia-obesity and hyperglycemia- abdominal obesity were also studied. The overall cardiovascular risk was assessed using Gaziano's tables. Results: 81.7 percent (210/257) of subjects had the hypertension-abdominal obesity´s phenotype and the frequency of moderate-high cardiovascular risk was 28.0 percent (72/257).The hypertension- abdominal obesity´s phenotype detected the highest proportion of subjects at moderate-high cardiovascular risk (64 of the 72); moderate-high cardiovascular risk was present in most of the subjects with this phenotype (88.8 percent), different from those without the phenotype (11.1 percent).Sensitivity (88.9 percent) and the negative predictive value (83.0 percent) show that the hypertension- abdominal obesity´s phenotype is a useful binomial for detecting individuals with moderate-high cardiovascular risk. Conclusions: The usefulness of the hypertension- abdominal obesity phenotype is superior to that of other phenotypic binomials and to the metabolic syndrome in order to identify people with moderate-high cardiovascular risk. The high sensitivity and high negative predictive value of the hypertension- abdominal obesity phenotype, as well as the simplicity of its determination, make it a good option for researching subjects with this risk(AU)

Utilidad de la prueba de tolerancia de comida mixta con Nutrial I para la evaluación de la función de las células beta en diabetes tipo 1 / Usefulness of the tolerance test of mixed food with Nutrial I for the assessment of beta cells function in diabetes type 1

RESUMEN Introducción: La prueba de tolerancia de comida mixta es considerada la prueba de oro para la medición de la producción de insulina endógena en pacientes con diabetes tipo 1. Objetivo: Determinar la utilidad de la prueba de tolerancia de comida mixta con Nutrial I para evaluar la función de las células ß en diabéticos tipo 1 de diagnóstico reciente y la relación de esa función con algunas características clínicas y bioquímicas. Métodos: Se estudiaron variables bioquímicas como la glucemia, hemoglobina glucosilada (HbA1c), péptido C y fracciones lipídicas. La prueba de tolerancia de comida mixta con Nutrial I se aplicó a 18 sujetos con diabetes tipo 1 de diagnóstico reciente y a 8 voluntarios con edades comprendidas entre 19 y 35 años. El consumo del suplemento Nutrial I se calculó según el peso del paciente. Se obtuvieron muestras para glucemia y péptido C a los -10, 0, 30, 60, 90 y 120 minutos. Resultados: Se observaron concentraciones elevadas de glucemia y disminuidas de péptido C durante la prueba de tolerancia de comida mixta en los diabéticos tipo 1 de diagnóstico reciente, en comparación con los voluntarios, así como, diferencias en las áreas bajo la curva de péptido C (AUC-pc) (p= 0,001). En los diabéticos tipo 1 de diagnóstico reciente se evidenció una correlación negativa entre el AUC-pc con los niveles de glucemia en ayunas (r= -0,747; p ( 0,0001) y la HbA1c (r= -0,535; p= 0,022). Por el contrario, se encontró una correlación positiva entre el AUC-pc y el péptido C en ayunas (r= 0,722; p= 0,001). El AUC-pc después de la prueba de tolerancia de comida mixta es mayor en los sujetos con glucemia en ayunas si GA < 7 mmol/L con respecto a los sujetos con glucemia en ayunas ( 7 mmol/L (p= 0,012). Conclusiones: El empleo del Nutrial I en la prueba de tolerancia de comida mixta fue útil en la evaluación de la función de las células β en diabéticos tipo 1 de diagnóstico reciente. Los valores bajos de glucemia en ayunas durante esta prueba son marcadores indirectos de una función residual de células ( más conservada en los diabéticos tipo 1 de diagnóstico reciente(AU)

ABSTRACT Introduction: The tolerance test of mixed food is considered the gold standard for the measurement of endogenous insulin production in patients with diabetes type 1. Objective: To determine the usefulness of the tolerance test of mixed food with Nutrial I to assess the ß-cells function in patients with diabetes type 1 of recent diagnosis and the relation of this function with some clinical and biochemical characteristics. Methods: There were studied biochemical variables as the blood glucose, glycosylated haemoglobin (HbA1c), C-peptide and lipid fractions. The tolerance test of mixed food with Nutrial I was applied to 18 individuals with diabetes type 1 of recent diagnosis and in 8 volunteers aged between 19 and 35 years old. The consumption of Nutrial I supplement was calculated according to the weight of the patient. Samples were obtained for blood glucose and C-peptide at -10, 0, 30, 60, 90 and 120 minutes. Results: There were observed high concentrations of glycemia and decreased amounts of C-peptide during the tolerance test of mixed food in recently diagnosed type 1 diabetics in comparison with the volunteers, as well as differences in areas under the curve of C-peptide (AUC-pc) (p= 0.001). In the recently diagnosed type 1 diabetics was evident a negative correlation between the AUC-pc with fasting plasma glucose levels (r= -0,747; p(0.0001) and HbA1c (r= -0,535; p= 0.022). On the contrary, it was found a positive correlation between the AUC-pc and fasting C-peptide (r = 0.722; p = 0.001). The AUC-pc after the tolerance test of mixed food was greater in subjects with fasting blood glucose < 7 mmol/L with respect to the subjects with fasting blood glucose ( 7 mmol/L (p= 0.012). Conclusions: The use of Nutrial I in the tolerance test of mixed food was useful in the assessment of the role of the β-cells in patients with recently diagnosed diabetes type 1. Low values of fasting blood glucose during this test are indirect markers of a residual function of (cells more preserved in type 1 diabetics of recent diagnosis(AU)

Relación del riesgo cardiovascular global con el ácido úrico y algunos componentes del síndrome metabólico / Relation of overall cardiovascular risk with uric acid and some components of the metabolic syndrome

Antecedentes: en los últimos años se ha debatido en cuanto al papel de ácido úrico como marcador independiente del riesgo cardiovascular y como posible componente del síndrome metabólico en personas con sobrepeso y obesidad. Objetivo: demostrar la asociación entre las concentraciones de ácido úrico con el riesgo cardiovascular global, y su nexo con algunos componentes del síndrome metabólico en personas con sobrepeso y obesidad. Métodos: se realizó un estudio observacional descriptivo transversal basado en 350 sujetos con edades comprendidas entre 19 y 70 años que fueron reclutados consecutivamente de una consulta para personas con sobrepeso y obesidad. Se estudiaron variables sociodemográficas, antecedentes patológicos personales, mediciones antropométricas y tensión arterial, así como las concentraciones de glucosa, insulina, lípidos, creatinina y ácido úrico. El riesgo cardiovascular global fue evaluado mediante las tablas de Gaziano, que no emplea análisis de laboratorio. Resultados: la frecuencia de riesgo cardiovascular global moderado/alto fue de 20,6 por ciento (72/350). Los individuos con riesgo cardiovascular global moderado/alto presentaron edades superiores, incremento en el índice de conicidad y de la tensión arterial sistólica, así como concentraciones elevadas de glucosa, colesterol, triglicéridos, creatinina y ácido úrico, que los individuos con riesgo cardiovascular global bajo. La frecuencia de personas con concentraciones de ácido úrico superior o igual al percentil 50 (296,5 mujeres y 365,0 hombres) fue superior en los individuos con riesgo cardiovascular global moderado/alto (62,5 por ciento [45/72]) que en aquellos con riesgo cardiovascular global bajo (47,12 por ciento [131/278], p= 0,014). De los sujetos con hiperuricemia, el 31,5 por ciento (23/73) presentó riesgo cardiovascular global moderado/alto, en cambio, en los individuos sin hiperuricemia, la frecuencia de riesgo cardiovascular global moderado/alto fue baja (17,7 por ciento [49/277], p= 0,014). Conclusiones: el incremento de las concentraciones de ácido úrico se relacionó con un mayor riesgo cardiovascular global. Los sujetos con riesgo cardiovascular global moderado/alto mostraron niveles elevados de la mayoría de los componentes del síndrome metabólico, así como de colesterol y ácido úrico. Este último podría utilizarse como un factor de riesgo potencial de enfermedad cardiovascular a nivel de la atención primaria de salud(AU)

Background: in recent years there has been a debate about the role of uric acid as an independent marker of cardiovascular risk and as a possible component of the metabolic syndrome in overweight and obese people. Objective: to demonstrate the association between uric acid concentrations and overall cardiovascular risk, and its connection with some components of the metabolic syndrome in overweight and obese people. Methods: a transversal descriptive, observational study was carried out based on 350 subjects aged from 19 to 70 years who were consecutively recruited from a consultation for overweight and obese people. Sociodemographic variables, personal pathological history, anthropometric measurements and blood pressure were studied, as well as glucose, insulin, lipids, creatinine and uric acid concentrations. The overall cardiovascular risk was assessed using Gaziano tables, which do not use laboratory analysis. Results: the frequency of moderate/high overall cardiovascular risk was 20.6 percent (72/350). Individuals with moderate/high overall cardiovascular risk were older, had increased conicity and systolic blood pressure, as well as higher glucose, cholesterol, triglycerides, creatinine and uric acid levels than individuals with low overall cardiovascular risk. The frequency of people with uric acid concentrations greater than or equal to the 50th percentile (296.5 women and 365.0 men) was higher in individuals with moderate/high overall cardiovascular risk (62.5 percent [45/72]) than in those with low global cardiovascular risk (47.12 percent [131/278], p= 0.014). Of the subjects with hyperuricemia, 31.5 percent (23/73) presented moderate/high overall cardiovascular risk, whereas, in individuals without hyperuricemia, the frequency of moderate/high overall cardiovascular risk was low (17.7 percent [ 49/277], p= 0.014). Conclusions: the increase in uric acid concentrations was associated with an increased overall cardiovascular risk. Subjects with moderate/high overall cardiovascular risk showed elevated levels of most components of the metabolic syndrome, as well as cholesterol and uric acid. The latter could be used as a potential risk factor for cardiovascular disease at the primary health care level(AU)

Relación del riesgo cardiovascular global con el ácido úrico y algunos componentes del síndrome metabólico / Relation of overall cardiovascular risk with uric acid and some components of the metabolic syndrome

Antecedentes: en los últimos años se ha debatido en cuanto al papel de ácido úrico como marcador independiente del riesgo cardiovascular y como posible componente del síndrome metabólico en personas con sobrepeso y obesidad. Objetivo: demostrar la asociación entre las concentraciones de ácido úrico con el riesgo cardiovascular global, y su nexo con algunos componentes del síndrome metabólico en personas con sobrepeso y obesidad. Métodos: se realizó un estudio observacional descriptivo transversal basado en 350 sujetos con edades comprendidas entre 19 y 70 años que fueron reclutados consecutivamente de una consulta para personas con sobrepeso y obesidad. Se estudiaron variables sociodemográficas, antecedentes patológicos personales, mediciones antropométricas y tensión arterial, así como las concentraciones de glucosa, insulina, lípidos, creatinina y ácido úrico. El riesgo cardiovascular global fue evaluado mediante las tablas de Gaziano, que no emplea análisis de laboratorio. Resultados: la frecuencia de riesgo cardiovascular global moderado/alto fue de 20,6 por ciento (72/350). Los individuos con riesgo cardiovascular global moderado/alto presentaron edades superiores, incremento en el índice de conicidad y de la tensión arterial sistólica, así como concentraciones elevadas de glucosa, colesterol, triglicéridos, creatinina y ácido úrico, que los individuos con riesgo cardiovascular global bajo. La frecuencia de personas con concentraciones de ácido úrico superior o igual al percentil 50 (296,5 mujeres y 365,0 hombres) fue superior en los individuos con riesgo cardiovascular global moderado/alto (62,5 por ciento [45/72]) que en aquellos con riesgo cardiovascular global bajo (47,12 por ciento [131/278], p= 0,014). De los sujetos con hiperuricemia, el 31,5 por ciento (23/73) presentó riesgo cardiovascular global moderado/alto, en cambio, en los individuos sin hiperuricemia, la frecuencia de riesgo cardiovascular global moderado/alto fue baja (17,7 por ciento [49/277], p= 0,014). Conclusiones: el incremento de las concentraciones de ácido úrico se relacionó con un mayor riesgo cardiovascular global. Los sujetos con riesgo cardiovascular global moderado/alto mostraron niveles elevados de la mayoría de los componentes del síndrome metabólico, así como de colesterol y ácido úrico. Este último podría utilizarse como un factor de riesgo potencial de enfermedad cardiovascular a nivel de la atención primaria de salud(AU)

Background: in recent years there has been a debate about the role of uric acid as an independent marker of cardiovascular risk and as a possible component of the metabolic syndrome in overweight and obese people. Objective: to demonstrate the association between uric acid concentrations and overall cardiovascular risk, and its connection with some components of the metabolic syndrome in overweight and obese people. Methods: a transversal descriptive, observational study was carried out based on 350 subjects aged from 19 to 70 years who were consecutively recruited from a consultation for overweight and obese people. Sociodemographic variables, personal pathological history, anthropometric measurements and blood pressure were studied, as well as glucose, insulin, lipids, creatinine and uric acid concentrations. The overall cardiovascular risk was assessed using Gaziano tables, which do not use laboratory analysis. Results: the frequency of moderate/high overall cardiovascular risk was 20.6 percent (72/350). Individuals with moderate/high overall cardiovascular risk were older, had increased conicity and systolic blood pressure, as well as higher glucose, cholesterol, triglycerides, creatinine and uric acid levels than individuals with low overall cardiovascular risk. The frequency of people with uric acid concentrations greater than or equal to the 50th percentile (296.5 women and 365.0 men) was higher in individuals with moderate/high overall cardiovascular risk (62.5 percent [45/72]) than in those with low global cardiovascular risk (47.12 percent [131/278], p= 0.014). Of the subjects with hyperuricemia, 31.5 percent (23/73) presented moderate/high overall cardiovascular risk, whereas, in individuals without hyperuricemia, the frequency of moderate/high overall cardiovascular risk was low (17.7 percent [ 49/277], p= 0.014). Conclusions: the increase in uric acid concentrations was associated with an increased overall cardiovascular risk. Subjects with moderate/high overall cardiovascular risk showed elevated levels of most components of the metabolic syndrome, as well as cholesterol and uric acid. The latter could be used as a potential risk factor for cardiovascular disease at the primary health care level(AU)

Asociación entre niveles de testosterona, sensibilidad a la insulina, adiposidad y parámetros lipídicos en hombres / Association between testosterone levels, insulin sensitivity, adiposity and lipid parameters in men

Introducción: Evidencias sugieren que la testosterona interviene en la regulación del metabolismo de la glucosa y los lípidos.Objetivo: determinar la relación entre los niveles de testosterona y la sensibilidad a la insulina, la adiposidad y los parámetros del metabolismo lipídico en hombres.Métodos: estudio transversal y descriptivo en 225 hombres, entre 35 y 60 años, con y sin trastornos de la tolerancia a la glucosa. Se midieron: talla, peso, circunferencias de la cintura y de la cadera. Se realizaron determinaciones de insulina, glicemia, testosterona, colesterol, HDL-colesterol, LDL-colesterol y triglicéridos. Se determinaron índices de sensibilidad y resistencia a la insulina.Resultados: se encontró una correlación negativa entre los niveles de testosterona y la resistencia a la insulina, y los parámetros de adiposidad explorados (índice de masa corporal, circunferencias abdominal y de la cadera, índice cintura/cadera). El nivel de testosterona fue menor en los sujetos con hipertrigliceridemia. En los sujetos con trastornos de la tolerancia, se encontró un aumento significativo de la frecuencia de obesidad abdominal en presencia de valores bajos de testosterona.Conclusiones: existe una asociación directa entre los niveles de testosterona y la sensibilidad a la insulina en la población estudiada. La disminución de los niveles de testosterona en presencia de los desórdenes asociados al síndrome metabólico, sugiere la indicación de una evaluación metabólica temprana a los pacientes con hipogonadismo(AU)

Introduction: Evidence suggests that testosterone participates in the regulation of glucose and lipid metabolism.Objective: determine the relationship between testosterone levels and insulin sensitivity, adiposity and metabolism parameters in men.Methods: a descriptive cross-sectional study was conducted of 225 men aged 35-60 with and without glucose tolerance disorders. The variables measured were height, weight, and waist and hip circumference. Determinations were made for insulin, glycemia, testosterone, cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Insulin sensitivity and resistance were also determined.Results: a negative correlation was found between testosterone levels/insulin resistance and the adiposity parameters considered (body mass index, waist and hip circumference and waist to hip ratio). Testosterone levels were lower in subjects with hypertriglyceridemia. Patients with tolerance disorders showed a significant increase in the frequency of abdominal obesity in the presence of low testosterone values.Conclusions: a direct relationship was found between testosterone levels and insulin sensitivity in the population studied. Reduced testosterone levels in the presence of disorders associated to metabolic syndrome suggest the need for an early metabolic assessment of patients with hypogonadism(AU)

Mecanismos inmunológicos e infertilidad femenina / Immune mechanisms and female infertility

Introducción: La infertilidad es un problema de salud mundial en aumento. Sus factores causales relacionados con el sexo femenino son mayoritarios. Recientemente se ha planteado una fuerte asociación entre los trastornos de la fertilidad y las alteraciones funcionales del sistema inmune, que contribuyen al origen y mantenimiento de la infertilidad.Objetivo: identificar en la literatura científica actualizada la contribución de los mecanismos inmunológicos en el desarrollo de la infertilidad femenina.Desarrollo: los mismos componentes inmunitarios que garantizan el éxito de la reproducción, pueden generar un entorno inflamatorio perpetuado, ante un estímulo antigénico, que produce lesión tisular. La inflamación desregulada repercute en reacciones autoinmunes contra las estructuras del aparato reproductor, y afectan su funcionalidad. La presencia de autoanticuerpos y citocinas proinflamatorias, como marcadores biológicos de estos fenómenos, ha sido reportada en entidades como la endometriosis y el síndrome de ovario poliquístico.Conclusiones: aunque se ha señalado que el sistema inmune desempeña un importante rol en el desarrollo de la reproducción femenina normal y patológica, el conocimiento obtenido en esta área sigue siendo exiguo. La subestimación de los factores inmunitarios en el escenario clínico muchas veces omite posibles alternativas diagnósticas y terapéuticas, que pudieran contribuir a incrementar la calidad del enfoque asistencial a las mujeres infértiles. La complejidad de los sistemas inmune y endocrino, y el corto alcance de las herramientas diagnósticas disponibles, son factores que contribuyen a esta insuficiência(AU)

Introduction: Infertility is a growing worldwide health problem whose causal factors are mostly associated to the female sex. A close relationship has recently been suggested between fertility disorders and functional alterations of the immune system contributing to and maintaining infertility.Objective: review updated scientific literature about the subject to identify the role of immune mechanisms in the development of female infertility.Development: the very immune components ensuring the success of reproduction may create a perpetuated inflammatory environment in the presence of an antigenic stimulus, resulting in the development of a tissular lesion. Dysregulated inflammation triggers autoimmune reactions against reproductive structures, affecting their operation. The presence of autoantibodies and proinflammatory cytokines as biological markers of these phenomena has been reported for conditions such as endometriosis and polycystic ovary syndrome.Conclusions: the immune system is known to play an important role in both normal and pathological female reproduction. However, information about the subject continues to be scant. Underestimation of the immune factors present in the clinical environment often blocks the way for diagnostic and therapeutic alternatives which could otherwise improve the quality of the care of infertile women. The complexity of the immune and endocrine systems, as well as the limited reach of the available diagnostic tools, are factors contributing to such insufficiency(AU)

Mecanismos inmunológicos e infertilidad femenina / Immune mechanisms and female infertility

Introducción: la infertilidad es un problema de salud mundial en aumento. Sus factores causales relacionados con el sexo femenino son mayoritarios. Recientemente se ha planteado una fuerte asociación entre los trastornos de la fertilidad y las alteraciones funcionales del sistema inmune, que contribuyen al origen y mantenimiento de la infertilidad.Objetivo: identificar en la literatura científica actualizada la contribución de los mecanismos inmunológicos en el desarrollo de la infertilidad femenina.Desarrollo: los mismos componentes inmunitarios que garantizan el éxito de la reproducción, pueden generar un entorno inflamatorio perpetuado, ante un estímulo antigénico, que produce lesión tisular. La inflamación desregulada repercute en reacciones autoinmunes contra las estructuras del aparato reproductor, y afectan su funcionalidad. La presencia de autoanticuerpos y citocinas proinflamatorias, como marcadores biológicos de estos fenómenos, ha sido reportada en entidades como la endometriosis y el síndrome de ovario poliquístico.Conclusiones: aunque se ha señalado que el sistema inmune desempeña un importante rol en el desarrollo de la reproducción femenina normal y patológica, el conocimiento obtenido en esta área sigue siendo exiguo. La subestimación de los factores inmunitarios en el escenario clínico muchas veces omite posibles alternativas diagnósticas y terapéuticas, que pudieran contribuir a incrementar la calidad del enfoque asistencial a las mujeres infértiles. La complejidad de los sistemas inmune y endocrino, y el corto alcance de las herramientas diagnósticas disponibles, son factores que contribuyen a esta insuficiencia(AU)

Introduction: infertility is a growing worldwide health problem whose causal factors are mostly associated to the female sex. A close relationship has recently been suggested between fertility disorders and functional alterations of the immune system contributing to and maintaining infertility.Objective: review updated scientific literature about the subject to identify the role of immune mechanisms in the development of female infertility.Development: the very immune components ensuring the success of reproduction may create a perpetuated inflammatory environment in the presence of an antigenic stimulus, resulting in the development of a tissular lesion. Dysregulated inflammation triggers autoimmune reactions against reproductive structures, affecting their operation. The presence of autoantibodies and proinflammatory cytokines as biological markers of these phenomena has been reported for conditions such as endometriosis and polycystic ovary syndrome.Conclusions: the immune system is known to play an important role in both normal and pathological female reproduction. However, information about the subject continues to be scant. Underestimation of the immune factors present in the clinical environment often blocks the way for diagnostic and therapeutic alternatives which could otherwise improve the quality of the care of infertile women. The complexity of the immune and endocrine systems, as well as the limited reach of the available diagnostic tools, are factors contributing to such insufficiency.

Asociación entre niveles de testosterona, sensibilidad a la insulina, adiposidad y parámetros lipídicos en hombres / Association between testosterone levels, insulin sensitivity, adiposity and lipid parameters in men

Introducción: evidencias sugieren que la testosterona interviene en la regulación del metabolismo de la glucosa y los lípidos.Objetivo: determinar la relación entre los niveles de testosterona y la sensibilidad a la insulina, la adiposidad y los parámetros del metabolismo lipídico en hombres.Métodos: estudio transversal y descriptivo en 225 hombres, entre 35 y 60 años, con y sin trastornos de la tolerancia a la glucosa. Se midieron: talla, peso, circunferencias de la cintura y de la cadera. Se realizaron determinaciones de insulina, glicemia, testosterona, colesterol, HDL-colesterol, LDL-colesterol y triglicéridos. Se determinaron índices de sensibilidad y resistencia a la insulina.Resultados: se encontró una correlación negativa entre los niveles de testosterona y la resistencia a la insulina, y los parámetros de adiposidad explorados (índice de masa corporal, circunferencias abdominal y de la cadera, índice cintura/cadera). El nivel de testosterona fue menor en los sujetos con hipertrigliceridemia. En los sujetos con trastornos de la tolerancia, se encontró un aumento significativo de la frecuencia de obesidad abdominal en presencia de valores bajos de testosterona.Conclusiones: existe una asociación directa entre los niveles de testosterona y la sensibilidad a la insulina en la población estudiada. La disminución de los niveles de testosterona en presencia de los desórdenes asociados al síndrome metabólico, sugiere la indicación de una evaluación metabólica temprana a los pacientes con hipogonadismo(AU)

Introduction: evidence suggests that testosterone participates in the regulation of glucose and lipid metabolism.Objective: determine the relationship between testosterone levels and insulin sensitivity, adiposity and metabolism parameters in men.Methods: a descriptive cross-sectional study was conducted of 225 men aged 35-60 with and without glucose tolerance disorders. The variables measured were height, weight, and waist and hip circumference. Determinations were made for insulin, glycemia, testosterone, cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Insulin sensitivity and resistance were also determined.Results: a negative correlation was found between testosterone levels/insulin resistance and the adiposity parameters considered (body mass index, waist and hip circumference and waist to hip ratio). Testosterone levels were lower in subjects with hypertriglyceridemia. Patients with tolerance disorders showed a significant increase in the frequency of abdominal obesity in the presence of low testosterone values.Conclusions: a direct relationship was found between testosterone levels and insulin sensitivity in the population studied. Reduced testosterone levels in the presence of disorders associated to metabolic syndrome suggest the need for an early metabolic assessment of patients with hypogonadism(AU)

Trypanosoma cruzi-infected pregnant women without vector exposure have higher parasitemia levels: implications for congenital transmission risk.

BACKGROUND: Congenital transmission is a major source of new Trypanosoma cruzi infections, and as vector and blood bank control continue to improve, the proportion due to congenital infection will grow. A major unanswered question is why reported transmission rates from T. cruzi-infected mothers vary so widely among study populations. Women with high parasite loads during pregnancy are more likely to transmit to their infants, but the factors that govern maternal parasite load are largely unknown. Better understanding of these factors could enable prioritization of screening programs to target women most at risk of transmission to their infants. METHODOLOGY/PRINCIPAL FINDINGS: We screened pregnant women presenting for delivery in a large urban hospital in Bolivia and followed infants of infected women for congenital Chagas disease. Of 596 women screened, 128 (21.5%) had confirmed T. cruzi infection; transmission occurred from 15 (11.7%) infected women to their infants. Parasite loads were significantly higher among women who transmitted compared to those who did not. Congenital transmission occurred from 31.3% (9/29), 15.4% (4/26) and 0% (0/62) of women with high, moderate and low parasite load, respectively (χx2 for trend 18.2; p<0.0001). Twin births were associated with higher transmission risk and higher maternal parasite loads. Infected women without reported vector exposure had significantly higher parasite loads than those who had lived in an infested house (median 26.4 vs 0 parasites/mL; p<0.001) with an inverse relationship between years of living in an infested house and parasite load. CONCLUSIONS/SIGNIFICANCE: We hypothesize that sustained vector-borne parasite exposure and repeated superinfection by T. cruzi may act as an immune booster, allowing women to maintain effective control of the parasite despite the down-regulation of late pregnancy.

Relación de la resistencia a la insulina con el riesgo cardiovascular, según diferentes tablas y factores de riesgo cardiovascular en sujetos sobrepesos y obesos / Association of the insulin resistance with the cardiovascular risk in overweight and obese persons, according to several cardiovascular risk tables and risk factors

Objetivo: determinar cuál de las tablas de riesgo cardiovascular y factores de riesgo, está más relacionada con la resistencia a la insulina en los adultos sobrepesos y obesos. Métodos: se estudiaron 350 pacientes sobrepesos u obesos de edades comprendidas entre los 19 y 70 años. Se les aplicó un cuestionario, que incluyó: edad, sexo, color de piel, hábitos tóxicos, práctica de actividad física y medicamentos utilizados. Las particularidades del examen físico realizado fueron: peso, talla, índice de masa corporal, tensión arterial, circunferencias de cintura y cadera e índice cintura-cadera. Los exámenes bioquímicos realizados fueron: glucosa, insulina, colesterol, triglicéridos y HDL-c en ayunas. La resistencia a la insulina fue evaluada mediante el índice de cálculo modelo homeostático de Mathews. Se utilizaron las tablas de Framingham, de la Organización Mundial de la Salud y las de Gaziano para medir el riesgo cardiovascular. Resultados: al comparar la frecuencia de riesgo cardiovascular según las tablas utilizadas, se observó que el riesgo moderado y alto, según Gaziano, fue superior al encontrado por Framingham y la Organización Mundial de la Salud (20,6 por ciento [72/350] vs. 2,9 por ciento [10/350] y 3,7 por ciento [13/350]). La frecuencia de resistencia a la insulina se distribuyó de manera similar para todas las tablas de riesgo cardiovascular. Cuando se analizó la relación entre la resistencia a la insulina y cada factor de riesgo cardiovascular, predominaron los triglicéridos elevados (68,7 por ciento), seguido por el colesterol ³ 5,2 mmol/L (60,2 por ciento), el índice de masa corporal ³ 30 (59,0 por ciento) y la hipertensión (59,5 por ciento). La sensibilidad de identificar resistencia a la insulina para cada tabla de riesgo cardiovascular, se comportó de manera uniforme en todas, sin embargo, las tablas según Gaziano, presentaron mayor especificidad (43,0 por ciento). Con relación a la sensibilidad y especificidad de la resistencia a la insulina para cada factor de riesgo cardiovascular, el índice de masa corporal ³ 30 mostró una alta especificidad (74,5 por ciento). Conclusiones: se aconseja utilizar las tablas de Gaziano debido a que detectaron un mayor número de individuos con riesgo cardiovascular, además de mostrar mayor especificidad en identificar sujetos con resistencia a la insulina. La obesidad y la hipertrigliceridemia fueron los factores de riesgo cardiovascular que más se asociaron con la resistencia a la insulina, y deben ser tomados en cuenta para el inicio de intervenciones terapéuticas, con el fin de evitar la aparición de enfermedad cardiovascular(AU)

Objective: to determine the cardiovascular risk and risk factor table that is most associated with the insulin resistance in overweight and obese patients. Methods: three hundred fifty overweight and obese patients, aged 19 to 70 years, were studied. They were questioned about age, sex, race, toxic habits, physical exercising and pharmaceutical consumption. The details of the physical exam included weight, size, body mass index, blood pressure, waist and hip circumference, waist-hip index. The biochemical exams were glucose, insulin, cholesterol, triglycerides and HDL-C on fasting. Mathews' homeostatic model estimation index served to evaluate the insulin resistance. The WHO table, the Framingham table and Gaziano table sere used to measure the cardiovascular risk. Results: the comparison of the cardiovascular risk frequency according to the tables showed that the moderate and the high risks in Gaziano table were higher than those of the Framingham and of the World Health Organization (20.6 percent [72/350] vs. 2.9 percent [10/350] and 3.7 percent [13/350]). The insulin resistance frequency was similar in all the cardiovascular risk tables. In the analysis of the relations between the insulin resistance and each cardiovascular risk factor, increased triglyceride indexes prevailed (68.7 percent) followed by cholesterol index of ³ 5.2 mmol/L (60.2 percent), body mass index of ³ 30 (59.0 percent) and hypertension (59,5 percent). The sensitivity of detection of insulin resistance observed in each cardiovascular risk table was similar; however, Gaziano tables showed higher specificity (43 percent). As to the sensitivity and specificity of the insulin resistance for each cardiovascular risk factor, the body mass index of ³ 30 yielded the highest specificity (74.5 percent). Conclusions: it is advisable to use Gaziano tables because they detected a higher number of individuals with cardiovascular risks, in addition to their higher specificity to detect subjects with insulin resistance. Obesity and hypertriglyceridemia were the cardiovascular risk factors most associated to the insulin resistance, so they should be taken into account to start therapeutic intervention in order to prevent the onset of some cardiovascular diseases(AU)

Relación de la resistencia a la insulina con el riesgo cardiovascular, según diferentes tablas y factores de riesgo cardiovascular en sujetos sobrepesos y obesos / Association of the insulin resistance with the cardiovascular risk in overweight and obese persons, according to several cardiovascular risk tables and risk factors

Objetivo: determinar cuál de las tablas de riesgo cardiovascular y factores de riesgo, está más relacionada con la resistencia a la insulina en los adultos sobrepesos y obesos. Métodos: se estudiaron 350 pacientes sobrepesos u obesos de edades comprendidas entre los 19 y 70 años. Se les aplicó un cuestionario, que incluyó: edad, sexo, color de piel, hábitos tóxicos, práctica de actividad física y medicamentos utilizados. Las particularidades del examen físico realizado fueron: peso, talla, índice de masa corporal, tensión arterial, circunferencias de cintura y cadera e índice cintura-cadera. Los exámenes bioquímicos realizados fueron: glucosa, insulina, colesterol, triglicéridos y HDL-c en ayunas. La resistencia a la insulina fue evaluada mediante el índice de cálculo modelo homeostático de Mathews. Se utilizaron las tablas de Framingham, de la Organización Mundial de la Salud y las de Gaziano para medir el riesgo cardiovascular. Resultados: al comparar la frecuencia de riesgo cardiovascular según las tablas utilizadas, se observó que el riesgo moderado y alto, según Gaziano, fue superior al encontrado por Framingham y la Organización Mundial de la Salud (20,6 por ciento [72/350] vs. 2,9 por ciento [10/350] y 3,7 por ciento [13/350]). La frecuencia de resistencia a la insulina se distribuyó de manera similar para todas las tablas de riesgo cardiovascular. Cuando se analizó la relación entre la resistencia a la insulina y cada factor de riesgo cardiovascular, predominaron los triglicéridos elevados (68,7 por ciento), seguido por el colesterol ³ 5,2 mmol/L (60,2 por ciento), el índice de masa corporal ³ 30 (59,0 por ciento) y la hipertensión (59,5 por ciento). La sensibilidad de identificar resistencia a la insulina para cada tabla de riesgo cardiovascular, se comportó de manera uniforme en todas, sin embargo, las tablas según Gaziano, presentaron mayor especificidad (43,0 por ciento). Con relación a la sensibilidad y especificidad de la resistencia a la....(AU)

Objective: to determine the cardiovascular risk and risk factor table that is most associated with the insulin resistance in overweight and obese patients. Methods: three hundred fifty overweight and obese patients, aged 19 to 70 years, were studied. They were questioned about age, sex, race, toxic habits, physical exercising and pharmaceutical consumption. The details of the physical exam included weight, size, body mass index, blood pressure, waist and hip circumference, waist-hip index. The biochemical exams were glucose, insulin, cholesterol, triglycerides and HDL-C on fasting. Mathews' homeostatic model estimation index served to evaluate the insulin resistance. The WHO table, the Framingham table and Gaziano table sere used to measure the cardiovascular risk. Results: the comparison of the cardiovascular risk frequency according to the tables showed that the moderate and the high risks in Gaziano table were higher than those of the Framingham and of the World Health Organization (20.6 percent [72/350] vs. 2.9 percent [10/350] and 3.7 percent [13/350]). The insulin resistance frequency was similar in all the cardiovascular risk tables. In the analysis of the relations between the insulin resistance and each cardiovascular risk factor, increased triglyceride indexes prevailed (68.7 percent) followed by cholesterol index of ³ 5.2 mmol/L (60.2 percent), body mass index of ³ 30 (59.0 percent) and hypertension (59,5 percent). The sensitivity of detection of insulin resistance observed in each cardiovascular risk table was similar; however, Gaziano tables showed higher specificity (43 percent). As to the sensitivity and specificity of the...(AU)

Imbalanced low-grade inflammation and endothelial activation in patients with type 2 diabetes mellitus and erectile dysfunction.

INTRODUCTION: Erectile dysfunction (ED) is highly prevalent among type 2 diabetes mellitus patients (T2DM). Although a link among systemic inflammation, endothelial dysfunction, and ED is described in clinical situations mainly related with coronary heart disease (CHD) risk, evidences of this link in T2DM patients are rather limited. AIMS: To evaluate the association between endothelial dysfunction and balance of pro-/anti-inflammatory mediators with ED presence and severity in T2DM. METHODS: We conducted a cross-sectional study of 190 T2DM patients without symptomatic CHD, 150 out of them with ED and 40 without ED. Serum levels of E-selectin, intercellular adhesion molecule-1, tumor necrosis factor-α (TNF-α), and interleukin (IL)-10 were measured using specific enzyme-linked immunosorbent assays (ELISAs). ED presence and severity were tested by the five-item version of the International Index of Erectile Function questionnaire. MAIN OUTCOME MEASURES: Differences in circulating levels of endothelial dysfunction (ICAM-1, E-selectin) and inflammatory/anti-inflammatory (TNF-α, IL-10, TNF-α : IL-10 ratio) markers between T2DM patients with and without ED, and assessment of biomarkers ED predictive value while adjusting for other known ED risk factors. RESULTS: Patients with ED were older and had longer duration of diabetes than patients without ED. E-selectin serum levels were significantly increased, while IL-10 were lower in patients with ED; because TNF-α levels tend to be higher, TNF-α : IL-10 ratio was more elevated in ED patients. No significant differences of ICAM-1 levels were observed between study groups. Endothelial activation markers and TNF-α, as well as diabetes duration, were negatively correlated with erectile function. On multivariate analysis including age, duration of diabetes, insulin treatment, hypertension, insulin resistance, fair-to-poor glycemic control, and metabolic syndrome, increments in E-selectin levels and TNF-α : IL-10 ratio predicted independently ED presence, while IL-10 increases were associated with lower risk of ED in T2DM patients. CONCLUSIONS: ED in T2DM patients without symptomatic CHD is associated with systemic endothelial dysfunction and a predominant, imbalanced low-grade inflammatory response.

Respuesta a la prueba de tuberculina (PPD) en escolares / Response to tuberculin test (PPD) in school children

Se aplicó PPD-5UT, para medir la sensibilidad a la Tuberculina, a 672 niños no vacunados con BCG en las escuelas públicas de la ciudad de San Cristóbal, R. D. Un 92% no presentó reacción, el 2.4% presentó reacción dudosa a la Tuberculina entre cinco y nueve milímetros y el 5% tuvo respuesta positiva con más de 10 mm. Se discuten las causas que pudieron intervenir en estos resultados y ofrecemos las conclusiones y recomendaciones pertinentes