RESUMEN
BACKGROUND: The gluten-free diet (GFD) has limitations, and there is intense research in the development of adjuvant therapies. AIM: To examine the effects of orally administered Aspergillus niger prolyl endopeptidase protease (AN-PEP) on inadvertent gluten exposure and symptom prevention in adult celiac disease (CeD) patients following their usual GFD. METHODS: This was an exploratory, double-blind, randomized, placebo-controlled trial that enrolled CeD patients on a long-term GFD. After a 4-wk run-in period, patients were randomized to 4 wk of two AN-PEP capsules (GliadinX; AVI Research, LLC, United States) at each of three meals per day or placebo. Outcome endpoints were: (1) Average weekly stool gluten immunogenic peptides (GIP) between the run-in and end of treatments and between AN-PEP and placebo; (2) celiac symptom index (CSI); (3) CeD-specific serology; and (4) quality of life. Stool samples were collected for GIP testing by ELISA every Tuesday and Friday during run-ins and treatments. RESULTS: Forty patients were randomized for the intention-to-treat analysis, and three were excluded from the per-protocol assessment. Overall, 628/640 (98.1%) stool samples were collected. GIP was undetectable (< 0.08 µg/g) in 65.6% of samples, and no differences between treatment arms were detected. Only 0.5% of samples had GIP concentrations sufficiently high (> 0.32 µg/g) to potentially cause mucosal damage. Median GIP concentration in the AN-PEP arm was 44.7% lower than in the run-in period. One-third of patients exhibiting GIP > 0.08 µg/g during run-in had lower or undetectable GIP after AN-PEP treatment. Compared with the run- in period, the proportion of symptomatic patients (CSI > 38) in the AN-PEP arm was significantly lower (P < 0.03). AN-PEP did not result in changes in specific serologies. CONCLUSION: This exploratory study conducted in a real-life setting revealed high adherence to the GFD. The AN-PEP treatment did not significantly reduce the overall GIP stool concentration. However, given the observation of a significantly lower prevalence of patients with severe symptoms in the AN-PEP arm, further clinical research is warranted.
Asunto(s)
Aspergillus niger , Aspergillus , Enfermedad Celíaca , Adulto , Humanos , Enfermedad Celíaca/diagnóstico , Dieta Sin Gluten , Glútenes , Prolil Oligopeptidasas , Calidad de VidaRESUMEN
Resumen Introducción: la diabetes mellitus tipo 2 (DM2) tiene gran importancia para la salud pública mundial, porque es una de las enfermedades no transmisibles más frecuentes, por la severidad y diversidad de sus complicaciones crónicas. Objetivo: el objetivo fue determinar el riesgo de desarrollar DM2 en personal de enfermería del Hospital T. J. Schestakow, San Rafael. Materiales y método: se realizó un estudio descriptivo de tipo transversal, se tomó una muestra no probabilística, que incluyó 109 enfermeros. Se evaluó el estado nutricional a través del índice de masa corporal (IMC) y la circunferencia de cintura (CC). Los datos personales y los obtenidos del cuestionario FINDRISC fueron adquiridos a través de un cuestionario realizado a los enfermeros. Resultados: el riesgo de desarrollar DM2 según las categorías de FINDRISC fue bajo en un 35,6% (n=41), ligeramente aumentado en un 39,4% (n=43), moderado en un 10,1% (n=11), alto y muy alto riesgo en un 12,9% (n=14). Esto está fuertemente influenciado por los antecedentes familiares de primer grado, la actividad física, la medicación antihipertensiva recibida, la glucemia elevada, el IMC, la circunferencia de cintura y la edad. El consumo de frutas y verduras no fue un factor determinante del riesgo de diabetes en la muestra estudiada (p>0,05). En cuanto a la CC y el IMC, ambos se correlacionaron de manera moderada-alta con el puntaje de FINDRISC, por lo cual estos indicadores fueron mejores predictores del riesgo para desarrollar diabetes. Conclusión: el riesgo de padecer DM2 es latente y constante, por lo que el uso de instrumentos fáciles y rápidos para su detección, como lo es el cuestionario FINDRISC, pueden ayudar en la prevención y toma de conciencia del autocuidado.
Abstract Introduction: type 2 diabetes mellitus (T2DM) has a great importance for global public health, because it is one of the most frequent non-communicable diseases, due to the severity and diversity of its chronic complications. Objective: the objective of this study was to determine the risk of developing T2DM in nursing staff of the T. J. Schestakow Hospital, San Rafael. Material and methods: a descriptive cross-sectional study was carried out, a non-probabilistic sample was taken, which included 109 nurses. Nutritional status was assessed through body mass index (BMI) and waist circumference (WC). Personal data and data obtained from the FINDRISC test were acquired through a questionnaire administered to nurses. Results: the risk of developing T2DM according to the Findrisc categories was low in 35.6% (n=41), slightly increased in 39.4% (n=43), moderate in 10.1% (n=11), high and very high risk in 12.9% (n=14). This is strongly influenced by first-degree family history, physical activity, antihypertensive medication, elevated blood glucose, BMI, waist circumference, and age. The consumption of fruits and vegetables was not a determinant of diabetes risk in the studied sample (p>0.05). Regarding WC and BMI, both were moderately to high correlated with the Findrisc score so these indicators were better predictors of the risk of developing diabetes. Conclusion: the risk of suffering from T2DM is latent and constant, so the use of quick and easy tools for its detection, such as the FINDRISC questionnaire, can help in the prevention and awareness of self-care.