Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial.

INTRODUCTION: New information and communication technologies (ICTs) may promote lifestyle changes, but no adequate evidence is available on their combined effect of ICTs with multifactorial interventions aimed at improving diet and increasing physical activity in patients with type 2 diabetes mellitus (DM2). The primary objective of this study is to assess the effect of a multifactorial intervention to increase physical activity and adherence to Mediterranean diet in DM2. METHODS AND ANALYSIS: Study scope and population: The study will be conducted at 'La Alamedilla' primary care research unit in Salamanca (Spain). 200 patients with DM2 of both sexes, aged 25-70 years and who meet the inclusion criteria and sign the informed consent will be recruited. Each participant will attend the clinic at baseline and 3 and 12 months after intervention. INTERVENTION: Both groups will be given short advice on diet and physical activity. The intervention group will also take five heart-healthy walks and attend a group session on diet education and will be trained on use of an application for smartphone (EVIDENT II) for 3 months. VARIABLES AND MEASUREMENT INSTRUMENTS: The main study endpoints will be changes in physical activity, as assessed by a pedometer and the International Physical Activity Questionnaire, and adherence to the Mediterranean diet, as evaluated by an adherence questionnaire and the Diet Quality Index. Anthropometric parameters and laboratory values, lifestyles and quality of life will also be assessed. ETHICS AND DISSEMINATION: It was approved by the Clinical Research Ethics Committee of Salamanca on 28/11/2016. TRIAL REGISTRATION: NCT02991079; Pre-results.

Sodium and potassium intake present a J-shaped relationship with arterial stiffness and carotid intima-media thickness.

OBJECTIVES: The purpose of this study was to analyse the relationship between sodium and potassium intake and vascular structure and function and to ascertain whether said relationship follows the pattern of a J-shaped curve. METHODS: A cross-sectional study was carried out in a primary care setting. Three hundred fifty-one subjects from the Vasorisk study were included and ranged in age from 30 to 80 years (mean 54.8, SD 11.7); 219 (62.4%) were females. Sodium and potassium intake were evaluated by means of a food frequency questionnaire. Arterial stiffness was assessed according to pulse wave velocity (PWV), ambulatory arterial stiffness index (AASI, AASI_BPVR), and central and peripheral augmentation index (AIx). Carotid intima-media thickness (C-IMT) was evaluated by ultrasonography. RESULTS: Age was lower in the quartiles with the highest sodium intake (p < 0.05), and no difference was observed between the sexes. Mean C-IMT, CAIx, AASI and AASI_BPVR were higher in the quartiles with higher sodium intake (p < 0.05 for both AASI and AASI_BPVR). Sodium intake was negatively correlated with C-IMT (r = -0.121, p < 0.05), PWV (r = -0.114, p < 0.05), AASI and AASI_BPVR (r = -0.155, p < 0.01). Potassium intake was positively correlated with Cornell VDP (r = 0.119, p < 0.05), CAIx (r = 0.178, p < 0.01) and PAIx (r = 0.202, p < 0.01). After adjustment, the morphology of the relationship between arterial stiffness parameters and C-IMT with quartiles of sodium intake resembles a J-shaped curve. The relationship between central and peripheral AIx and C-IMT and potassium intake resembles a J-shaped curve. CONCLUSION: The relationship of sodium and potassium intake with vascular structure and function, as evaluated with C-IMT, PWV, AASI and peripheral and central AIx, resembles a J-shaped curve, which is similar to what has been proposed in the case of cardiovascular morbimortality.

Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol.

BACKGROUND: Diabetic patients show an increased prevalence of non-dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk.The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus or metabolic syndrome. DESIGN: This is an observational prospective study with 5 years duration, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up. SETTING: The study will be carried out in the urban primary care setting. STUDY POPULATION: Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included. MEASUREMENTS: Patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. Height, weight, heart rate and abdominal circumference. Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity C-reactive protein. Clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. Common carotid artery ultrasound for the determination of mean carotid intima-media thickness. Electrocardiogram for assessing left ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together with antiplatelet drugs. DISCUSSION: The results of this study will help to know and quantify the prognostic value of central arterial pressure and pulse wave velocity in relation to the evolution of the subclinical target organ damage markers and the possible incidence of cardiovascular events in patients with type 2 diabetes mellitus.

[Efficacy of an educational intervention group on changes in lifestyles in hypertensive patients in primary care: a randomized clinical trial]. / Eficacia de una intervención educativa grupal sobre cambios en los estilos de vida en hipertensos en atención primaria: un ensayo clínico aleatorio.

BACKGROUND: Healthy lifestyles are associated with less risk of cardiovascular disease. The aim of this study is to evaluate the effectiveness of a group educational strategy in lifestyle changes, as well as the control of risk factors and cardiovascular risk in hypertensive patients. METHODS: Randomized clinical trial carried out in Primary Care. 101 hypertensive patients were selected by random sampling, aged 35-74; 51 patients were randomized to the intervention group (IG) (aged: 64,5+/-9,7, 56% women) and other 50 to the control group(CG)(aged: 65,4+/-8,4, 68% women). We performed a basal evaluation and an educational intervention on lifestyles, six sessions during one year, and final-point evaluation. Effect of intervention was evaluated through of cardiovascular risk (Framingham), blood pressure, lipid profile, waist circumference, body mass index (BMI), nutrient consumption, physical exercise (7-PAR day) and quality of life(SF-36). RESULTS: Basal blood pressure was 136,8/82,7 mmHg IG and 139,3/79,3 CG, cardiovascular risk was 11,1% y 12,3% respectively. Systolic blood pressure decreased 5,6+/-19,6 (p=0,07) IG and 7,1+/-16,3 mmHg (p=0,004) GC, and diastolic decreased 3,9+/-10,8 (p=0,02) and 2,7+/-11,5 mmHg (p=0,10) respectively. BMI decreased 0,3+/-1,6 points IG (p=0,17) and increased 0,1+/-1,5 CG (p=0,81). Coronary risk decreased 0,8+/-6,5 points IG and increased 0,2+/- 6,8 CG; effect of intervention was a reduction in 1 point (CI95%-3,9/1,9)(p=0,48). Calories ingestion decreased 42,8+/-1141,2 Kcal/day p=0,14) IG and 278,9+/-1115,9(p=0,62) CG. Physical exercise increased in both groups: 3,6+/-19 IG (p=0,20) and 3,9+/-14,9 mets/hour/week CG (p=0,07). CONCLUSIONS: There was a higher decline of cardiovascular risk in the intervention group than control group, we did not find statistically significant differences between both groups in parameters evaluated.

Eficacia d euna intervención educativa grupal sobre cambios en los estilos de vida de Hipertensos en Atención Primaria: Un ensayo Clínico Aleatorio / Effycacy of an Educational Intervention Group on Changes in Lifestyles in Hypertensive Patients in Primary Care: A Randomized Clinical Trial

Fundamentos: Los estilos de vida saludables se relacionan con un menor riesgo de enfermedades cardiovasculares. El objetivo del estudio es evaluar la eficacia de una estrategia educativa grupal en la modificación de estilos de vida, control de factores de riesgo y riesgo cardiovascular (RCV) en personas hipertensas.Método: Ensayo clínico aleatorio en Atención Primaria. Se seleccionaron por muestreo aleatorio 101 personas hipertensas de 35 a 74 años, randomizando 51 al grupo de intervención (GI)(64,5±9,7 años, 56% mujeres) y 50 al control (GC) (65,4±8,4 años, 68% mujeres). Se realizó una evaluación basal, una intervención educativa grupal sobre cambios de estilos de vida (seis sesiones durante un año) y una evaluación final. El efecto de la intervención se evaluó con RCV (Framingham), presión arterial(PA), perfil lipídico, perímetro de cintura, índice de masa corporal(IMC), consumo de nutrientes con encuesta validada, ejercicio físico con 7-PAR Day y calidad de vida con SF-36.Resultados: PA basal 136,8/82,7 mmHg en GI y 139,3/79,3 mmHg y en GC, RCV:11,1% (GI) y 12,3% (GC). La PA sistólica descendió 5,6±19,6 mmHg (p=0,07) en GI, y 7,1±16, mmHg (p=0,004) en GC, la diastólica 3,9±10,8 (p=0,02), y 2,7±11, mmHg (p=0,10) respectivamente. El IMC descendió 0,3±1,6 puntos en GI(p=0,17), y aumentó 0,1±1,5 en GC(p=0,81). El RCV descendió 0,8±6,5 puntos en GI y aumentó 0,2±6,8 en GC, el efecto de la intervención fue un descenso de 1 punto (IC95%:3,9-1,9) (p=0,48). La ingesta disminuyó en GI: 42,8±1141,2 Kcal/día(p=0,14), y en GC: 278,9±1115,9 (p=0,62). El ejercicio (mets/hora/semana) aumentó en ambos, 3,6±19 en GI(p=0,20) y 3,9±14,9 en GC(p=0,07).Conclusión: Encontramos mayor descenso del riesgo cardiovascular en el grupo de intervención, sin existir diferencias estadísticamente significativas en los parámetros evaluados entre ambos grupos (AU)

Background: Healthy lifestyles are associated with less risk of cardiovascular disease. The aim of this study is to evaluate the effectiveness of a group educational strategy in lifestyle changes, as well as the control of risk factors and cardiovascular risk in hypertensive patients.Methods: Randomized clinical trial carried out in Primary Care. 101 hypertensive patients were selected by random sampling, aged 35-74; 51 patients were randomized to the intervention group (IG) (aged: 64,5±9,7, 56% women) and other 50 to the control group(CG)(aged: 65,4±8,4, 68% women). We performed a basal evaluation and an educational intervention on lifestyles, six sessions during one year, and final-point evaluation. Effect of intervention was evaluated through of cardiovascular risk (Framingham), blood pressure, lipid profile, waist circumference, body mass index (BMI), nutrient consumption, physical exercise (7-PAR day) and quality of life(SF-36).Results: Basal blood pressure was 136,8/82,7 mmHg IG and 139,3/79,3 CG, cardiovascular risk was 11,1% y 12,3% respectively. Systolic blood pressure decreased 5,6±19,6 (p=0,07) IG and 7,1±16,3 mmHg (p=0,004) GC, and diastolic decreased 3,9±10,8 (p=0,02) and 2,7±11,5 mmHg (p=0,10) respectively. BMI decreased 0,3±1,6 points IG (p=0,17) and increased 0,1±1,5 CG (p=0,81). Coronary risk decreased 0,8±6,5 points IG and increased 0,2± 6,8 CG; effect of intervention was a reduction in 1 point (CI95%-3,9÷1,9)(p=0,48). Calories ingestion decreased 42,8±1141,2 Kcal/day p=0,14) IG and 278,9±1115,9(p=0,62) CG. Physical exercise increased in both groups: 3,6±19 IG (p=0,20) and 3,9±14,9 mets/hour/week CG (p=0,07).Conclusions: There was a higher decline of cardiovascular risk in the intervention group than control group, we did not find statistically significant differences between both groups in parameters evaluated (AU)