Comprehensive approach to people with type 2 diabetes. Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for the comprehensive approach of people with type 2 diabetes according to evidence-based medicine. PARTICIPANTS: Members of the Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition. METHODS: The recommendations were formulated according to the degrees of evidence of the Standards of Medical Care in Diabetes-2022. After reviewing the available evidence and formulating recommendations by the authors of each section, several rounds of comments were developed incorporating the contributions and voting on controversial points. Finally, the final document was sent to the rest of the members of the area for review and incorporation of contributions, to finally carry out the same process with the members of the Spanish Society of Endocrinology and Nutrition Board of Directors. CONCLUSIONS: The document establishes practical recommendations based on the latest available evidence for the management of people with type 2 diabetes.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 30 November 2019 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Executive summary: Position document: Evaluation and management of hypoglycemia in the patient with diabetes mellitus 2020. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. / Resumen ejecutivo: Documento de posicionamiento: evaluación y manejo de la hipoglucemia en el paciente con diabetes mellitus 2020. Grupo de Trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición.

OBJECTIVE: To provide practical recommendations for the evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition (SEEN). METHODS: The recommendations were made based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to establish both the strength of the recommendations and the level of evidence. A systematic search was made in MEDLINE (PubMed) for the available evidence on each subject, and articles written in English and Spanish with an inclusion date up to 28 February 2020 were reviewed. This executive summary takes account of the evidence incorporated since 2013. CONCLUSIONS: The document establishes practical evidence-based recommendations regarding the evaluation and management of hypoglycemia in patients with diabetes mellitus.

Documento de abordaje integral de la diabetes tipo 2 / Document on a comprehensive approach to type 2 diabetes mellitus

Objetivo: El tratamiento de la diabetes tipo 2 (DM2) es complejo y su propósito es reducir la morbimortalidad, por lo que su manejo tiene que incluir: un control glucémico individualizado precoz (mediante una adecuada educación diabetológica, modificaciones del estilo de vida y tratamiento farmacológico), el control de los factores de riesgo cardiovascular (CV), la detección y tratamiento precoz de las complicaciones y la evaluación de las comorbilidades asociadas. El objetivo fue elaborar un documento para unificar los aspectos necesarios para el abordaje integral de las personas con DM2. Participantes: Miembros del Grupo de trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición. Métodos: Se realizó una revisión de la evidencia disponible relativa a cada aspecto del manejo de la diabetes: objetivos de control glucémico, dieta y ejercicio, tratamiento farmacológico, tratamiento y control de factores de riesgo, detección de complicaciones y manejo del paciente frágil con DM2. Las recomendaciones se formularon según los grados de evidencia recogidos en los Standards of Medical Care in Diabetes 2018. Tras la formulación de las recomendaciones el documento fue consensuado por los miembros del Grupo de trabajo de Diabetes Mellitus de la Sociedad Española de Endocrinología y Nutrición. Conclusiones: El objetivo de este documento es proporcionar, desde el punto de vista del endocrinólogo clínico, unas recomendaciones prácticas basadas en la evidencia acerca de todos los aspectos necesarios para el abordaje integral de la DM2

Objective: Treatment of type 2 diabetes mellitus (T2DM) is complex and is intended to decrease morbidity and mortality. Management should therefore include adequate diabetes education, lifestyle changes, drug treatment to achieve early blood glucose control and reduction of cardiovascular (CV) risk factors, early detection and treatment of complications, and assessment of associated comorbidities. The objective was to prepare a document including all aspects required for a comprehensive approach to T2DM. Participants: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology. Methods: The available evidence regarding each aspect of diabetes management (blood glucose control goals, diet and exercise, drug treatment, risk factor management and control, detection of complications, and management of frail patients) was reviewed. Recommendations were formulated based on the grades of evidence stated in the 2018 Standards of Medical Care in Diabetes. Recommendations were discussed and agreed by the working group members. Conclusions: This document is intended to provide evidence-based practical recommendations for comprehensive management of T2DM by clinical endocrinologists

Impact of hypoglycemic episodes on health-related quality of life of type-2 diabetes mellitus patients: development and validation of a specific QoLHYPO© questionnaire.

BACKGROUND: Hypoglycemia is a limiting factor to achieving optimal glycemic control in patients with type-2 diabetes mellitus (T2DM), increasing risk of death and complications, reducing health-related quality of life (HRQoL) and work productivity and increasing healthcare costs. The study's primary objective was to develop and validate a specific questionnaire to assess the impact of hypoglycemia on the HRQoL of T2DM patients (QoLHYPO© questionnaire). METHODS: A two-phase multicenter prospective, longitudinal, observational, epidemiologic study of consecutively enrolled patients, not involving any drug, was conducted: In phase 1 (questionnaire development), patients who had given their written informed consent, who were at least 30 years of age, had been diagnosed with T2DM at least 5 years prior, had an HbA1c test in the previous 3 months, and a hypoglycemic episode in the previous 6 months were included. To validate the questionnaire and assess reliability and responsiveness, phase 2 included two cohorts of patients. Patients in the reliability cohort would likely have stable clinical course during the 3 weeks following inclusion in the study and patients in the responsiveness cohort would likely experience changes in their clinical course in the 3 months after enrollment. RESULTS: Phase 1 included 168 patients: 10 attended semi-structured interviews, 18 for face validity, and 140 for the pilot test (Rasch analysis). Phase 2 included 227 patients: 142 in the reliability cohort and 85 in the responsiveness cohort. Of the 37 items initially included in Phase 1, 11 (floor/ceiling effect analysis) and 13 (Rasch analysis) were discarded. The final version of the questionnaire consisted of 13 items. Phase 2 results showed the questionnaire was unidimensional and able to accurately assess HRQoL. Intra-observer reproducibility (ICC = 0.920) and internal consistency (Cronbach's alpha: visit 1 = 0.912; visit 2 = 0.901) were high, showing high reliability. Internal responsiveness was moderate (standardized effect size 0.5-0.8) and external responsiveness was lower (AUC > 0.5; not statistically significant). Minimal clinically important difference (MCID) was estimated to be 3.2 points. CONCLUSIONS: The QoLHYPO© questionnaire is a tool that can be used in routine clinical practice to assess the impact of hypoglycemia on the HRQoL of T2DM patients.

Clinical Effects of Liraglutide in a Real-World Setting in Spain: eDiabetes-Monitor SEEN Diabetes Mellitus Working Group Study.

INTRODUCTION: A limitation with randomized controlled trials is that, while they provide unbiased evidence of the efficacy of interventions, they do so under unreal conditions and in a very limited and highly selected patient population. Our aim was to provide data about the effectiveness of liraglutide treatment in a real-world and clinical practice setting. METHODS: In a retrospective and observational study, data from 753 patients with type 2 diabetes were recorded through an online tool (eDiabetes-Monitor). RESULTS: Mean baseline glycated hemoglobin (HbA1c) was 8.4 ± 1.4% and mean body mass index (BMI) was 38.6 ± 5.4 kg/m(2). After 3-6 months of treatment with liraglutide, we observed a change in HbA1c of -1.1 ± 1.2%, -4.6 ± 5.3 kg in weight and -1.7 ± 2.0 kg/m(2) in BMI (p < 0.001 for all). Compared to baseline, there was a significant reduction in systolic blood pressure (-5.9 mmHg, p < 0.001), diastolic blood pressure (-3.2 mmHg, p < 0.001), LDL cholesterol (-0.189 mmol/l, p < 0.001) and triglycerides (-0.09 mmol/l, p = 0.021). In patients switched from DPP-4 inhibitors, liraglutide induced a decrease of -1.0% in HbA1c (p < 0.001) and a reduction in weight (-4.5 kg, p < 0.001). In patients treated with liraglutide as an add-on therapy to insulin a decrease of -1.08% in HbA1c (p < 0.001) and a weight reduction of -4.15 kg (p < 0.001) were observed. CONCLUSION: Our study confirms the effectiveness of liraglutide in a real-life and clinical practice setting. FUNDING: Spanish Society of Endocrinology and Nutrition.

Position statement: hypoglycemia management in patients with diabetes mellitus. Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition.

OBJECTIVE: To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus. PARTICIPANTS: Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. METHODS: Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (PubMed). Papers in English and Spanish with publication date before 15 February 2013 were included. For recommendations about drugs only those approved by the European Medicines Agency were included. After formulation of recommendations, they were discussed by the Working Group. CONCLUSIONS: The document provides evidence-based practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus.

A computer tool for cardiovascular risk estimation according to Framingham and SCORE equations.

Background Currently, we have different scales to estimate the cardiovascular risk of one individual. The most commonly used in clinical practice are the Framingham method and the SCORE project. Both are based on mathematical models that take into account the presence and intensity of various risk factors for cardiovascular morbidity and mortality. Aims and objectives The aim of our study was to develop a measurement system that allows unifying criteria of both models. Thus, we will be able to estimate the cardiovascular risk globally in a cohort of patients instead of individually. Methods The study included a representative subgroup of 50 patients treated at in the Endocrinology Service of Virgen de las Nieves University Hospital, Granada, below 30 years or above 75 years. The equations used in the present study were in strict compliance with the original publications. The reliability and validity of results were tested, comparing them with results obtained using calculation programs developed, available on-line. The degree of similarity was determined by means of the Dice index and the distance between our values and those of the other programs were compared by using the expression: Da-b = √Σ(a - b)(2) Results The results of the present study demonstrated our application to be reliable and valid for cardiovascular risk assessment. Our observations also demonstrated differences in the criteria applied to create cardiovascular risk calculation tools. This may have repercussions on clinical decisions for some patients, suggesting a need to compare and standardize these criteria, ensuring that programs developed for this calculation correctly manage the different risk categories considered. Conclusion The present study validates a computer tool developed for the simultaneous calculation of cardiovascular disease probability by applying Framingham-Anderson and Framingham-Wilson methods, the Spanish adaptations of Regicor and Dorica, and the SCORE project.

Reduction of false-negative papillary thyroid carcinomas by the routine analysis of BRAF(T1799A) mutation on fine-needle aspiration biopsy specimens: a prospective study of 814 thyroid FNAB patients.

OBJECTIVES: To evaluate prospectively the usefulness of the routine determination of BRAF(T1799A) mutation on thyroid fine-needle aspiration biopsy (FNAB) to detect cytopathology false negative papillary thyroid carcinomas (PTC) and, therefore, as a tool to improve the sensitivity of the preoperative cytopathological diagnosis of PTC in thyroid nodules. BACKGROUND: FNAB is the most reliable diagnostic test to discriminate between malignant and benign thyroid nodules, but nondiagnostic results remain a clinical management dilemma. BRAF(T1799A) mutation is the most prevalent genetic alteration in thyroid cancers and is specific for PTC, characteristics that make it the most potentially helpful genetic tool to improve the diagnostic accuracy of FNAB. METHODS: An exhaustive recruitment of all patients subjected to thyroid FNAB in our institution during 4 years was performed. BRAF(T1799A) mutation was determined on thyroid FNAB specimens by PCR and restriction fragment length polymorphism, plus direct sequencing in positive samples. RESULTS: BRAF(T1799A) mutation on FNAB detected 47.2% (17/36) of PTC cases. It confirmed preoperatively 45.5% (5/11) of the PTC cases in the indeterminate category and decreased the rate of cytopathology false-negatives in 33.3% (6/18), improving the combined (BRAF(T1799A) mutation + cytopathological analysis) sensitivity of the detection of PTC on FNAB in 16.7%. CONCLUSIONS: BRAF(T1799A) mutation improves the diagnosis of PTC on FNAB, mainly because of the detection of cytopathology false-negatives, and it can be helpful in the routine analysis of thyroid nodules, especially in clinical settings with moderate sensitivity to detect PTC on FNAB.

Presencia de la mutación BRAF T1799A en el tumor primario como indicador de riesgo, recidiva o persistencia de carcinoma papilar de tiroides / BRAF T1799. A mutation in the primary tumor as a marker of risk, recurrence, or persistence of papillary thyroid carcinoma

Antecedentes y objetivo. La mutación BRAFT1799A se ha relacionado con características tumorales de más agresividad, recidiva tumoral y persistencia de carcinoma papilar de tiroides (CPT), aunque no todos los estudios apoyan esta asociación. En éste, se analiza la asociación entre la presencia de la mutación BRAFT1799A en el tumor primario de pacientes con CPT y las características clinicopatológicas de riesgo, recidiva y persistencia tumoral. Pacientes, material y método. Hemos seguido a 97 pacientes intervenidos de CPT durante una mediana de 64,1 meses. La mutación BRAFT1799A se determinó en ácido desoxirribonucleico procedente de muestras de la tiroidectomía inicial mediante amplificación por PCR del exón 15 del gen braf y análisis de los fragmentos de restricción con la enzima TspRI. Los casos positivos fueron confirmados por secuenciación. La asociación estadística entre la mutación BRAFT1799A y las diferentes variables se estudió mediante los correspondientes tests de contraste de hipótesis más regresión logística. Resultados. El 46,4% de los pacientes eran positivos para la mutación BRAFT1799A. Tras análisis bivariante y multivariante, la mutación BRAFT1799A sólo se asociaba con edad superior a 60 años (odds ratio [OR] = 5,5; intervalo de confianza [IC] del 95%, 1,4-21,9; p=0,019) y tamaño de 1cm o superior (OR=3,6; IC del 95%, 1,2-10,3; p=0,016). No se asociaba con subtipos histológicos, metástasis, recidiva, necesidad de nuevos tratamientos ablativos con I131 o de otras intervenciones quirúrgicas debidas a la aparición de metástasis o persistencia de enfermedad al final del seguimiento. Conclusiones. La mutación BRAFT1799A está asociada a edad superior a 60 años y tamaño tumoral de 1cm o mayor, pero no con otras características clinicopatológicas, recidiva tumoral o persistencia de enfermedad (AU)

Background and objective. The BRAFT1799A mutation is reported to be associated to aggressive, persistent, and recurrent tumor in papillary thyroid carcinoma (PTC) patients. Association of the BRAFT1799A mutation in the primary tumor with the clinicopathological characteristics of PTC patients was analyzed. Patients, material and methods. Ninety-seven PTC patients were followed up for a median of 64.1 months. The BRAFT1799A mutation was analyzed in DNA from initial thyroidectomy biopsies by PCR amplification and restriction fragment length polymorphism using TspRI enzyme. Positive cases were confirmed by DNA sequencing. Statistical association between BRAFT1799A mutation and clinicopathological characteristics was analyzed by the relevant hypothesis tests and logistic regression. Results. 46.4% of patients were positive for the BRAFT1799A mutation. Bivariate and multivariate analysis showed the BRAFT1799A mutation to be only associated to age over 60 years (odds ratio [OR] = 5.5; 95% confidence interval [CI],1.4-21.9; p=0.019) and to tumor size of 1cm or greater (OR=3.6, 95% CI, 1.2-10.3; p=0.016). The BRAFT1799A mutation was not associated to histological subtype, metastasis, recurrence, more aggressive treatments (ablative I131 therapy or surgery), or PTC persistence at the end of follow-up. Conclusions. The BRAFT1799A mutation is associated to age over 60 and a tumor size of 1cm or greater, but not to other clinicopathological characteristics, tumor recurrence or PTC persistence (AU)

[BRAF(T1799A) mutation in the primary tumor as a marker of risk, recurrence, or persistence of papillary thyroid carcinoma]. / Presencia de la mutación BRAF(T1799A) en el tumor primario como indicador de riesgo, recidiva o persistencia de carcinoma papilar de tiroides.

BACKGROUND AND OBJECTIVE: The BRAF(T1799A) mutation is reported to be associated to aggressive, persistent, and recurrent tumor in papillary thyroid carcinoma (PTC) patients. Association of the BRAF(T1799A) mutation in the primary tumor with the clinicopathological characteristics of PTC patients was analyzed. PATIENTS, MATERIAL AND METHODS: Ninety-seven PTC patients were followed up for a median of 64.1 months. The BRAF(T1799A) mutation was analyzed in DNA from initial thyroidectomy biopsies by PCR amplification and restriction fragment length polymorphism using TspRI enzyme. Positive cases were confirmed by DNA sequencing. Statistical association between BRAF(T1799A) mutation and clinicopathological characteristics was analyzed by the relevant hypothesis tests and logistic regression. RESULTS: 46.4% of patients were positive for the BRAF(T1799A) mutation. Bivariate and multivariate analysis showed the BRAF(T1799A) mutation to be only associated to age over 60years (odds ratio [OR] = 5.5; 95% confidence interval [CI],1.4-21.9; p=0.019) and to tumor size of 1cm or greater (OR=3.6, 95% CI, 1.2-10.3; p=0.016). The BRAF(T1799A) mutation was not associated to histological subtype, metastasis, recurrence, more aggressive treatments (ablative I(131) therapy or surgery), or PTC persistence at the end of follow-up. CONCLUSIONS: The BRAFT1799A mutation is associated to age over 60 and a tumor size of 1cm or greater, but not to other clinicopathological characteristics, tumor recurrence or PTC persistence.

Influencia de la edad y del índice de masa corporal en la presión arterial clínica y la presión arterial de 24 horas en pacientes tratados y no tratados de hipertensión arterial / Influence of age and body mass index on clinical blood pressure and 24-hour ambulatory blood pressure monitoring in treated and untreated patients with hypertension

Fundamento y objetivo: Conocer el impacto de la obesidad en la presión arterial clínica (PAC) y la monitorización ambulatoria de la presión arterial (MAPA). Pacientes y métodos: Hemos estudiado a 594 pacientes entre 18 y 80 (media ± desviación estándar, 46,07 ± 15,53) años, con evolución media del diagnóstico de hipertensión arterial (HTA) de 4,51 ± 7,32 años. Fumadores el 38,2%, mujeres el 51,17%. Fueron estudiados en nuestra Unidad de Hipertensión Arterial por: a) sospecha de HTA de bata blanca; b) HTA no controlada con 3 fármacos, y c) HTA con discrepancia entre el grado de control domiciliario y el de la consulta. Descartamos HTA secundaria y complicación vascular. Resultados: Las medias de edad de los pacientes con peso normal, sobrepeso y obesidad fueron respectivamente 36 ±13,22; 44,34 ± 14,93, y 51,95 ± 13,9 años. La PAC fue mayor conforme aumentaba el índice de masa corporal (IMC) (presión arterial sistólica [PAS], 137,63 ± 15,81 mmHg y presión arterial diastólica [PAD], 92,88 ± 16,06 mmHg; PAS, 147,75 ± 21,62 mmHg y PAD, 93,21 ± 11,11 mmHg; PAS, 156,13 ± 24,55 mmHg y PAD, 96,44 ± 11,61 mmHg). El número de pacientes con sobrepeso y obesidad que recibieron tratamiento era mayor y mostraban mayores PAS en MAPA de 24 h, así como en los períodos diurno y nocturno, y tenían concentraciones más elevadas de triglicéridos y ácido úrico y más bajos de colesterol unido a lipoproteínas de alta densidad (cHDL). Había diferencias en el IMC entre los pacientes dipper (28,27) y non-dipper (29,35; p < 0,005). Los coeficientes de correlación en la regresión entre el IMC y la PAS clínica y de 24 h fueron r = 0,28 y r = 0,2 (p < 0,0001). Las variables más influyentes en la regresión lineal fueron: edad, años de evolución de la HTA, PAS clínica, PAS diurna, cHDL y colesterol unido a lipoproteínas de baja densidad (cLDL). La reducción del filtrado glomerular y la presencia de microalbuminuria fueron mayores en los pacientes con sobrepeso y obesidad (p = 0,02 y p = 0,002). Conclusiones: Nuestro estudio muestra el efecto perjudicial del sobrepeso y la obesidad en la PAC y la MAPA en los pacientes con dudosa hipertensión, en los pacientes con mal control y en los que no responden adecuadamente a un tratamiento. Los pacientes con sobrepeso u obesidad presentaban más afecciones de órganos diana (AU)

Background and objetive: Assess the role of the obesity on the clinic blood pressure (CBP) and on ambulatory monitoring blood pressure (AMBP). Patients and methods: We studied 594 patients from 18 to 80 years old (46.07 ± 15.53), with an average time from diagnosis of 4.51 ± 7.32 years. 38.2% were smokers and 51.17% women. They were admitted in the Hypertension Unit because: a) suspicion of white coat hypertension; b) uncontrolled hypertension with three drugs treatment, and c) discrepancy between clinic and home control. We discarded secondary hypertension and vascular complications. Results: The mean age of patients with normal weight, overweight and obesity was respectively (36 ± 13.22 years, 44.34 ± 14.93 and 51.95 ± 13.9 years). CBP was higher when BMI increased (SBP 137.63 ± 15.81 and DBP 92.8 ± 16.06 mmHg; SBP 147.75 ± 21.62 and DBP 93.21 ± 11.11 mmHg; and SBP 156.13 ± 24.55 and DBP 96.44 ± 11.61 mmHg). The number of overweight and obesity patients under treatments was higher than in normal weight patients, and both showed higher figurs of SBP in the 24 hours AMBP, and in nocturnal and diurnal period too, and they had triglycerides and uric acid values more elevated and a lower value of HDLc. The difference in BMI between dipper (28.27) and non dipper (29.35) was significative (p < 0.005). The regressive correlation coefficient among BMI and clinic SBP and 24 hours AMBP was r = 0.28 and 0.2 (p < 0.0001). The more prominent variables in linear regression were: age, years of evolution, clinic SBP, diurnal SBP, HDLc and LDLc. The glomerular filtration reduction and the presence of microalbuminuria were superior on overweight and obesity patients (p = 0.02 and p = 0.002). Conclusions: Our study shows the deleterious effect on CBP and AMBP in overweight and obesity, in poor controlled patients and in those not responding properly to a treatment. The overweight and the obesity patients also suffered the most in target organs (AU)

Comparación de los modelos SCORE y Framingham-DORICA para estimar el riesgo cardiovascular en una cohorte de pacientes hipertensos del sur de España / Comparison of the Score and Framingham-DORICA models to estimate the cardiovascular risk in a cohort of hypertensive patients from Southern Spain

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