Relationship between intima-media thickness of the common carotid artery and arterial stiffness in subjects with and without type 2 diabetes: a case-series report

Background: We examined the relationship between the intima-media thickness of the common carotid artery (CCA-IMT) and arterial stiffness, assessed by pulse wave velocity (PWV), the ambulatory arterial stiffness index (AASI) and the augmentation index (AIx) in subjects with and without type 2 diabetes. Methods: A case-series study was made in 366 patients (105 diabetics and 261-non-diabetics). Ambulatory blood pressure monitoring was performed on a day of standard activity with the SpaceLabs 90207 system. AASI was calculated as "1-slope" from the within-person regression of diastolic-on-systolic ambulatory blood pressure readings. PWV and AIx were measured with the SphygmoCor system, and a Sonosite Micromax ultrasound unit was used for automatic measurements of CCA-IMT. Results: PWV, AASI and CCA-IMT were found to be greater in diabetic patients, while no differences in AIx were observed between the two groups. CCA-IMT was independently correlated to the three measures of arterial stiffness in both groups. We found an increase in CCA-IMT of 0.40, 0.24 and 0.36 mm in diabetics, and of 0.48, 0.17 and 0.55 mm in non-diabetics for each unit increase in AASI, AIx and PWV. The variability of CCA-IMT was explained mainly by AASI, AIx and gender in diabetic patients, and by age, gender, AASI and PWV in non-diabetic patients. Conclusions: CCA-IMT showed a positive correlation to PWV, AASI and AIx in subjects with and without type 2 diabetes. However, when adjusting for age, gender and heart rate, the association to PWV was lost in diabetic patients, in the same way as the association to Alx in non-diabetic patients. The present study demonstrates that the three measures taken to assess arterial stiffness in clinical practice are not interchangeable, nor do they behave equally in all subjects

Cocoa intake and arterial stiffness in subjects with cardiovascular risk factors

<p>Abstract</p> <p>Background</p> <p>To analyze the relationship of cocoa intake to central and peripheral blood pressure, arterial stiffness, and carotid intima-media thickness in subjects with some cardiovascular risk factor.</p> <p>Findings</p> <p>Design: A cross-sectional study of 351 subjects (mean age 54.76 years, 62.4% males). Measurements: Intake of cocoa and other foods using a food frequency questionnaire, central and peripheral (ambulatory and office) blood pressure, central and peripheral augmentation index, pulse wave velocity, ambulatory arterial stiffness index, carotid intima-media thickness, and ankle-brachial index.</p> <p>Results: Higher pulse wave velocity and greater cardiovascular risk were found in non-cocoa consumers as compared to high consumers (<it>p </it>< 0.05). In a multivariate analysis, these differences disappeared after adjusting for age, gender, the presence of diabetes, systolic blood pressure and antihypertensive and lipid-lowering drug use. All other arterial stiffness measures (central and peripheral augmentation index, ambulatory arterial stiffness index, ankle-brachial index, and carotid intima-media thickness) showed no differences between the different consumption groups.</p> <p>Conclusions</p> <p>In subjects with some cardiovascular risk factors, cocoa consumption does not imply improvement in the arterial stiffness values.</p> <p>Trial Registration</p> <p>Clinical Trials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01325064">NCT01325064</a>.</p

Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study)

Background The increasing use of smartphones by older adults also increases their potential for improving different aspects of health in this population. Some studies have shown promising results in the improvement of cognitive performance through lifestyle modification. All this may have a broad impact on the quality of life and carrying out daily living activities. The objective of this study is to evaluate the effectiveness of combining the use of smartphone and smartband technology for 3 months with brief counseling on life habits, as opposed to providing counseling only, in increasing physical activity and improving adherence to the Mediterranean diet. Secondary objectives are to assess the effect of the intervention on body composition, quality of life, independence in daily living activities and cognitive performance. Methods This study is a two-arm cluster-randomized trial that will be carried out in urban health centers in Spain. We will recruit 160 people aged between 65 and 80 without cardiovascular disease or cognitive impairment (score in the Mini-mental State Examination ≥24). On a visit to their center, intervention group participants will be instructed to use a smartphone application for a period of 3 months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient’s daily nutritional composition. The primary outcome will be the change in the number of steps measured by accelerometer. Secondary variables will be adherence to the Mediterranean diet, sitting time, body composition, quality of life, independence in daily living activities and cognitive performance. All variables will be measured at baseline and on the assessment visit after 3 months. A telephone follow-up will be carried out at 6 months to collect self-reported data regarding physical activity and adherence to the Mediterranean diet. Discussion Preventive healthy aging programs should include health education with training in nutrition and lifestyles, while stressing the importance of and enhancing physical activity; the inclusion of new technologies can facilitate these goals. The EVIDENT-AGE study will incorporate a simple, accessible intervention with potential implementation in the care of older adults.This study was supported in part by grants funded by the Instituto de Salud Carlos III, Institute of Biomedical Research of Salamanca (IBSAL)-IBY17/00003, and the Spanish Research Network for Preventive Activities and Health Promotion in Primary Care (REDIAPP)-RD16/0007

EVIDENT 3 study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application study protocol

FUNDAMENTOS: La tecnología móvil, cuando se incluye dentro de las intervenciones de componentes múltiples, podría contribuir a una pérdida de peso más efectiva. El objetivo de este proyecto es evaluar el impacto de añadir el uso de la aplicación EVIDENT 3, diseñada para promover la salud a los hábitos de vida, a las estrategias de modificación tradicionales empleadas para la pérdida de peso. También se evaluarán otras conductas específicas (caminar, ingesta de calorías, tiempo sentado) y resultados (calidad de vida, marcadores inflamatorios, mediciones del envejecimiento arterial). MÉTODOS: Ensayo clínico aleatorio y multicéntrico con 2 grupos paralelos. El estudio se llevará a cabo en el ámbito de la atención primaria e incluirá 700 sujetos de 20 a 65 años, con un índice de masa corporal (27,5-40kg/m2), que están clínicamente clasificados como sedentarios. El resultado primario será la pérdida de peso. Los resultados secundarios incluirán cambios en la forma de caminar (pasos/d), el tiempo de permanencia sentado (min/sem), la ingesta calórica (kcal/d), la calidad de vida, el envejecimiento arterial (índice de aumento) y los niveles de marcadores proinflamatorios. Los resultados se medirán en la línea de base, después de 3 meses y después de 1 año. Los participantes serán asignados aleatoriamente al grupo de intervención (IG) o al grupo de control (CG). Ambos grupos recibirán el asesoramiento tradicional de estilo de vida de atención primaria antes de la asignación al azar. A los sujetos del IG se les prestará un teléfono inteligente y una banda inteligente por un período de 3 meses, correspondiente a la duración de la intervención. La aplicación del EVIDENTE 3 integra la información recogida por la banda inteligente sobre la actividad física y la información autodeclarada por los participantes sobre la ingesta diaria de alimentos. Utilizando esta información, la aplicación genera recomendaciones y objetivos personalizados para la pérdida de peso. DISCUSIÓN: Hay una gran diversidad en las aplicaciones utilizadas obteniendo diferentes resultados en la mejora del estilo de vida y la pérdida de peso. Las poblaciones estudiadas no son homogéneas y generan resultados diferentes. Los resultados de este estudio ayudarán a nuestra comprensión de la eficacia de las nuevas tecnologías, combinadas con el asesoramiento tradicional, para reducir la obesidad y permitir estilos de vida más saludables.INTRODUCTION: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. METHODS: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5–40kg/m2), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. DISCUSSION: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles.• Ministerio de Ciencia e Innovación y el Instituto de Salud Carlos III/Europa y Fondo de Desarrollo Regional (FEDER). Proyectos PI16/00101, PI16/00952, PI16/00765, PI16/00659, PI16/00421, PI16/00170 • Junta de Castilla y León. Ayuda GRS 1277/B/16peerReviewe

Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial

Introduction The intake of polyphenols has certain health benefits. This study will aim to assess the effect of adding a daily amount of chocolate high in cocoa content and polyphenols to the normal diet on blood pressure, vascular function, cognitive performance, quality of life and body composition in postmenopausal women. Methods and analysis Here we plan a randomised clinical trial with two parallel groups involving a total of 140 women between 50 and 64 years in the postmenopausal period, defined by amenorrhoea of at least 12 consecutive months. The main variable will be the change in blood pressure. Secondary variables will be changes in vascular function, quality of life, cognitive performance and body composition. The intervention group will be given chocolate containing 99% cocoa, with instructions to add 10 g daily to their normal diet for 6 months. The daily nutritional contribution of this amount of chocolate is 59 kcal and 65.4 mg of polyphenols. There will be no intervention in the control group. All variables will be measured at the baseline visit and 3 and 6 months after randomisation, except cognitive performance and quality of life, which will only be assessed at baseline and at 6 months. Recruitment is scheduled to begin on 1 June 2018, and the study will continue until 31 May 2019. Ethics and dissemination This study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca, Spain (‘CREC of Health Area of Salamanca’), in February 2018. A SPIRIT checklist is available for this protocol. The clinical trial has been registered at ClinicalTrials. gov provided by the US National Library of Medicine, number NCT03492983. The results will be disseminated through open access peer-reviewed journals, conference presentations, broadcast media and a presentation to stakeholders.Gerencia Regional de Castilla y León (GRS 1583/B/1

Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial

Background: mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date. Objective: To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity. Methods: Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the intervention group (IG) and 126 in the control group (CG). The IG subjects were briefed on the use of the Evident 3 app and a smart band (Mi Band 2, Xiaomi) for 3 months to promote healthy lifestyles. All measurements were recorded in the baseline visit and at 3 and 12 months. The carotid-femoral pulse wave velocity (cfPWV) and the central hemodynamic parameters were measured using a SphigmoCor System® device, whereas the brachial-ankle pulse wave velocity (baPWV) and the Cardio Ankle Vascular Index (CAVI) were measured using a VaSera VS-2000® device. Results: Of the 253 subjects who attended the initial visit, 237 (93.7%) completed the visit at 3 months of the intervention, and 217 (85.3%) completed the visit at 12 months of the intervention. At 12 months, IG showed a decrease in peripheral augmentation index (PAIx) (−3.60; 95% CI −7.22 to −0.00) and ejection duration (ED) (−0.82; 95% CI −1.36 to −0.27), and an increase in subendocardial viability ratio (SEVR) (5.31; 95% CI 1.18 to 9.44). In CG, cfPWV decreased at 3 months (−0.28 m/s; 95% CI −0.54 to −0.02) and at 12 months (−0.30 m/s, 95% CI −0.54 to −0.05), central diastolic pressure (cDBP) decreased at 12 months (−1.64 mm/Hg; 95% CI −3.19 to −0.10). When comparing the groups we found no differences between any variables analyzed. Conclusions: In sedentary adults with overweight or obesity, the multicomponent intervention (Smartphone app and an activity-tracking band) for 3 months did not modify arterial stiffness or the central hemodynamic parameters, with respect to the control group. However, at 12 months, CG presented a decrease of cfPWV and cDBP, whereas IG showed a decrease of PAIx and ED and an increase of SEVR

Ischemic Postconditioning Reduces Reperfusion arrhythmias by Adenosine Receptors and Protein Kinase C Activation but Is Independent of KATP Channels or Connexin 43

Ischemic postconditioning (IPoC) reduces reperfusion arrhythmias but the antiarrhythmic mechanisms remain unknown. The aim of this study was to analyze IPoC electrophysiological effects and the role played by adenosine A1, A2A and A3 receptors, protein kinase C, ATP-dependent potassium (KATP) channels, and connexin 43. IPoC reduced reperfusion arrhythmias (mainly sustained ventricular fibrillation) in isolated rat hearts, an effect associated with a transient delay in epicardial electrical activation, and with action potential shortening. Electrical impedance measurements and Lucifer-Yellow diffusion assays agreed with such activation delay. However, this delay persisted during IPoC in isolated mouse hearts in which connexin 43 was replaced by connexin 32 and in mice with conditional deletion of connexin 43. Adenosine A1, A2A and A3 receptor blockade antagonized the antiarrhythmic effect of IPoC and the associated action potential shortening, whereas exogenous adenosine reduced reperfusion arrhythmias and shortened action potential duration. Protein kinase C inhibition by chelerythrine abolished the protective effect of IPoC but did not modify the effects on action potential duration. On the other hand, glibenclamide, a KATP inhibitor, antagonized the action potential shortening but did not interfere with the antiarrhythmic effect. The antiarrhythmic mechanisms of IPoC involve adenosine receptor activation and are associated with action potential shortening. However, this action potential shortening is not essential for protection, as it persisted during protein kinase C inhibition, a maneuver that abolished IPoC protection. Furthermore, glibenclamide induced the opposite effects. In addition, IPoC delays electrical activation and electrical impedance recovery during reperfusion, but these effects are independent of connexin 43.Fil: Diez, Emiliano Raúl. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto de Medicina y Biología Experimental de Cuyo; Argentina. Universidad Nacional de Cuyo. Facultad de Ciencias Médicas; ArgentinaFil: Sánchez, Jose Antonio. Centro de Investigación Biomédica en Red sobre Enfermedades Cardiovasculares; España. Universidad Autonoma de Barcelona. Hospital Vall D' Hebron. Instituto de Investigación Vall D'hebron. Serv.de Cardiología,laboratorio de Cardiología Experimenta; EspañaFil: Prado, Natalia Jorgelina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto de Medicina y Biología Experimental de Cuyo; Argentina. Universidad Nacional de Cuyo. Facultad de Ciencias Médicas; ArgentinaFil: Ponce Zumino, Amira Zulma. Universidad Nacional de Cuyo. Facultad de Ciencias Médicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto de Medicina y Biología Experimental de Cuyo; ArgentinaFil: García-Dorado, David. Universidad Autonoma de Barcelona. Hospital Vall D' Hebron. Instituto de Investigación Vall D'hebron. Serv.de Cardiología,laboratorio de Cardiología Experimenta; España. Centro de Investigación Biomédica en Red sobre Enfermedades Cardiovasculares; EspañaFil: Miatello, Roberto Miguel. Universidad Nacional de Cuyo. Facultad de Ciencias Médicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Mendoza. Instituto de Medicina y Biología Experimental de Cuyo; ArgentinaFil: Rodríguez-Sinovas, Antonio. Centro de Investigación Biomédica en Red sobre Enfermedades Cardiovasculares; España. Universidad Autonoma de Barcelona. Hospital Vall D' Hebron. Instituto de Investigación Vall D'hebron. Serv.de Cardiología,laboratorio de Cardiología Experimenta; Españ

A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Trial registrationClinicalTrials.gov, identifier: NCT03990792

EVIDENT smartphone app, a new method for the dietary record: comparison with a food frequency questionnaire

Background: More alternatives are needed for recording people’s normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health. Objective: The aim of this study was to compare the estimated values of energy intake, macro- and micronutrient, and alcohol consumption gathered using the EVIDENT II smartphone app against the data estimated with a food frequency questionnaire (FFQ) in an adult population aged 18 to 70 years. Methods: We included 362 individuals (mean age 52 years, SD 12; 214/362, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT app during a period of 3 months and through an FFQ. Both methods estimate the average nutritional composition, including energy intake, macro- and micronutrients, and alcohol. Through the app, the values of the first week of food recording, the first month, and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year before the moment of interview. Results: The intraclass correlation for the estimation of energy intake with the FFQ and the app shows significant results, with the highest values returned when analyzing the app’s data for the full 3-month period (.304, 95% CI 0.144-0.434; P<.001). For this period, the correlation coefficient for energy intake is .233 (P<.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r=.676 and r=.155; P<.001), respectively. The estimation of daily intake of energy, macronutrients, and alcohol presents higher values in the FFQ compared with the EVIDENT app data. Considering the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the app (a difference of 408.7, 95% CI 322.7-494.8; P<.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (.4, 95% CI −1.2 to 2.0; P=.62). Conclusions: The EVIDENT app is significantly correlated to FFQ in the estimation of energy intake, macro- and micronutrients, and alcohol consumption. This correlation increases with longer app recording periods. The EVIDENT app can be a good alternative for recording food intake in the context of longitudinal or intervention studies. Trial Registration: ClinicalTrials.gov NCT02016014; http://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/760i8EL8Q).Spanish Ministry of Science and Innovation and Carlos III Health Institute/European Regional Development Fund (FIS: PI13/00618, PI13/01526, PI13/00058, PI13/01635, PI13/02528, PI12/01474; RETICS: RD12/0005, RD16/0007), Regional Health Management of Castilla and León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13), and the Infosalud Foundatio

Glycemic markers and relation with arterial stiffness in Caucasian subjects of the MARK study

[EN]BACKGROUND: Effect of prediabetes and normal glucose on arterial stiffness remains controversial. The primary aim of this study was to investigate the relationship of fasting plasma glucose (FPG), postprandial glucose (PG) and glycosylated haemoglobin (HbA1c) with brachial-ankle pulse wave velocity (baPWV) and cardio-ankle vascular index (CAVI) in Caucasian adults. The secondary aim was to analyse this relationship by glycaemic status. METHODS: Cross-sectional study. Setting: Primary care. Participants: 2,233 subjects, 35-74 years. Measures: FPG (mg/dL) and HbA1c (%) of all subjects were measured using standard automated enzymatic methods. PG (mg/dL) was self-measured at home two hours after meals (breakfast, lunch and dinner) for one day using an Accu-chek ® glucometer. CAVI was measured using a VaSera VS-1500® device (Fukuda Denshi), and baPWV was calculated using a validated equation. RESULTS: CAVI and baPWV values were significantly higher in subjects with diabetes mellitus than in glucose normal and prediabetes groups (p<0.001). FPG, PG and HbA1c were positively associated with CAVI and baPWV. The β regression coefficient for: HbA1c was 0.112 (CI 95% 0.068 to 0.155) with CAVI, 0.266 (CI 95% 0.172 to 0.359) with baPWV; for PG was 0.006 (CI 95% 0.004 to 0.009 and for FPG was 0.005 (CI 95% 0.002 to 0.008) with baPWV; and for PG was 0.002 (CI 95% 0.001 to 0.003) and 0.003 (CI 95% 0.002 to 0.004) with CAVI (p<0.01 in all cases). When analysing by hyperglycaemic status, FPG, PG and HbA1c were positively associated with CAVI and baPWV in subjects with type 2 diabetes mellitus. CONCLUSION: FPG, PG and HbA1c show a positive association with CAVI and baPWV, in Caucasian adults with intermediate cardiovascular risk factors. When analysing by hyperglycaemic status, the association is only maintained in subjects with type 2 diabetes mellitus