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

Adiposity measures and arterial stiffness in primary care: the MARK prospective observational study

Arterial stiffness; Body mass index; waist-to-height ratioRigidesa arterial; Índex de massa corporal; Relació d'alçada i pesRigidez arterial; Índice de masa corporal; Relación de altura y pesoBACKGROUND The cardiovascular risk of obesity is potentially increased by arterial stiffness. OBJECTIVE To assess the relationship of adiposity measures with arterial stiffness in Caucasian adults with intermediate cardiovascular risk. SETTING Six Spanish health centres. PARTICIPANTS We enrolled 2354 adults (age range, 35-74 years; mean age, 61.4±7.7 years, 61.9% male). METHODS This is a cross-sectional study that analyses data from the baseline visit of the improving interMediAte RisK management (MARK) study. The main outcome variables were body mass index (BMI), waist-to-height ratio (WHtR), Clínica Universidad de Navarra-body adiposity estimation (CUN-BAE) body fat percentage and body roundness index (BRI). Vascular function was assessed by the cardio-ankle vascular index (CAVI) with the VaSera device; brachial-ankle pulse wave velocity (baPWV) was determined using a validated equation. RESULTS The mean adiposity measures were a BMI of 29.2±4.4, WHtR of 0.61±0.07, CUN-BAE of 35.7±1.7 and BRI of 5.8±1.7. The mean stiffness measures were a CAVI of 8.8±1.2 and baPWV of 14.9±2.5. In multiple linear regression analyses, all adiposity measures were negatively associated with CAVI and baPWV (p<0.01 for all) after adjustment for possible factors of confusion. The proportion of CAVI variability via the adiposity measures were 5.5% for BMI, 5.8% for CUN-BAE, 3.8% for WHtR and 3.7% for BRI. These were higher among diabetic, obese, younger (≤62 years) and non-hypertensive subjects who had similar activity and sedentary profiles. CONCLUSIONS Adiposity measures are negatively associated with arterial stiffness measures. The percentage of variation in CAVI explained by its relation to the different measures of adiposity ranges from 5.8% (CUN-BAE) to 3.7% (BRI). In the case of baPWV, it oscillates between 0.7% (CUN-BAE and BMI) and 0.1% (WHtR). TRIAL REGISTRATION NUMBER NCT01428934

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial

CDATA[CDATA[Background: Health promotion is a key process of current health systems Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two 01 more risk behaviours, that is why a multiple intervention might be more effective and efficient The primary objectives are to evaluate the effectiveness, the cost effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. CDATA[CDATA[Methods: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care It will be carried out in 26 PHC centres in Spam The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the ''5A''s" It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community) Incremental cost per quality adjusted life year gamed measured by the tanffs of the EuioQo! 5D questionnaire will be estimated. The implementation strategy is based on the ''Consolidated Framework for Implementation Research, a set of discrete implementation strategies and an evaluation framework. CDATA[CDATA[Discussion: EIRA study will determine the effectiveness and cost effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation

Effectiveness of an mHealth intervention combining a smartphone app and smart band on body composition in an overweight and obese population: Randomized controlled trial (EVIDENT 3 study)

Background: Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. Objective: This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. Methods: A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. Results: The mHealth intervention produced a greater loss of body weight (–1.97 kg, 95% CI –2.39 to –1.54) relative to standard counselling at 3 months (–1.13 kg, 95% CI –1.56 to –0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; –1.84 kg, 95% CI –2.48 to –1.20), percentage of body fat (PBF; –1.22%, 95% CI –1.82% to 0.62%), and BMI (–0.77 kg/m2, 95% CI –0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of –1.18 kg (95% CI –2.30 to –0.06) and BMI of –0.47 kg/m2 (95% CI –0.80 to –0.13), whereas the obese group only experienced a change in BMI of –0.53 kg/m2 (95% CI –0.86 to –0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of –1.03 kg (95% CI –1.74 to –0.33), PBF of –0.76% (95% CI –1.32% to –0.20%), and BMI of –0.5 kg/m2 (95% CI –0.83 to –0.19). Conclusions: The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect

Adiposity measures and arterial stiffness in primary care: the MARK prospective observational study

Arterial stiffness; Body mass index; waist-to-height ratioRigidesa arterial; Índex de massa corporal; Relació d'alçada i pesRigidez arterial; Índice de masa corporal; Relación de altura y pesoBACKGROUND The cardiovascular risk of obesity is potentially increased by arterial stiffness. OBJECTIVE To assess the relationship of adiposity measures with arterial stiffness in Caucasian adults with intermediate cardiovascular risk. SETTING Six Spanish health centres. PARTICIPANTS We enrolled 2354 adults (age range, 35-74 years; mean age, 61.4±7.7 years, 61.9% male). METHODS This is a cross-sectional study that analyses data from the baseline visit of the improving interMediAte RisK management (MARK) study. The main outcome variables were body mass index (BMI), waist-to-height ratio (WHtR), Clínica Universidad de Navarra-body adiposity estimation (CUN-BAE) body fat percentage and body roundness index (BRI). Vascular function was assessed by the cardio-ankle vascular index (CAVI) with the VaSera device; brachial-ankle pulse wave velocity (baPWV) was determined using a validated equation. RESULTS The mean adiposity measures were a BMI of 29.2±4.4, WHtR of 0.61±0.07, CUN-BAE of 35.7±1.7 and BRI of 5.8±1.7. The mean stiffness measures were a CAVI of 8.8±1.2 and baPWV of 14.9±2.5. In multiple linear regression analyses, all adiposity measures were negatively associated with CAVI and baPWV (p<0.01 for all) after adjustment for possible factors of confusion. The proportion of CAVI variability via the adiposity measures were 5.5% for BMI, 5.8% for CUN-BAE, 3.8% for WHtR and 3.7% for BRI. These were higher among diabetic, obese, younger (≤62 years) and non-hypertensive subjects who had similar activity and sedentary profiles. CONCLUSIONS Adiposity measures are negatively associated with arterial stiffness measures. The percentage of variation in CAVI explained by its relation to the different measures of adiposity ranges from 5.8% (CUN-BAE) to 3.7% (BRI). In the case of baPWV, it oscillates between 0.7% (CUN-BAE and BMI) and 0.1% (WHtR). TRIAL REGISTRATION NUMBER NCT01428934

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

Biomarkers; Blood Glucose; Arterial stiffnessBiomarcadors; Glucosa sanguínia; Rigidesa arterialBiomarcadores; Glucosa en sangre; Rigidez arterialBACKGROUND: 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. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01428934. Registered 2 September 2011. Retrospectively registered. Last updated September 8, 201

Association of metabolic syndrome and its components with arterial stiffness in Caucasian subjects of the MARK study: a cross‑sectional trial

The cardio-ankle vascular index (CAVI) and brachial-ankle pulse wave velocity (baPWV) can reflect both central and peripheral arterial stiffness. Metabolic syndrome (MetS) and its components may increase arterial stiffness and the risk of cardiovascular diseases. However, the correlation of MetS and its components with arterial stiffness is still not clear. The primary aim of this study is thus the relationship using baPWV and CAVI in Caucasian adults with intermediate cardiovascular risk. The secondary aim is to analyze sex differences. Methods This study analyzed 2351 subjects aged 35–74 years (mean, 61.4 ± 7.7 years) comprising 61.7 % males and enrolled in the improving interMediAte Risk management (MARK) study. CAVI was measured using a VaSera VS-1500 ® device, and baPWV was calculated using a validated equation. MetS was defined based on the Joint Scientific Statement National Cholesterol Education Program III. Waist circumference, blood pressure, fasting plasma glucose, and lipid profile were measured. Results MetS was found in 51.9 % of the subjects. All MetS components except reduced HDL-cholesterol (p = 0.578) were associated with CAVI. High density lipoprotein cholesterol (p = 0.075) and waist circumference (p = 0.315) were associated with baPWV. The different MetS components that assess dyslipidemia using the stiffness measures show different associations according to patient sex. The high blood pressure component had a greater odds ratio (OR) for both baPWV ≥ 17.5 m/sec (OR = 6.90, 95 % CI 3.52–13.519) and CAVI ≥ 9 (OR = 2.20, 95 % CI 1.63–1.90). Conclusions MetS and all its components (except HDL-cholesterol with baPWV and CAVI and WC with baPWV) were associated with baPWV and CAVI. However, there were sex differences in the association of MetS and its components with baPWV and CAVI. Data from this study suggest a greater association of CAVI and baPWV values with MetS components in males than in females and indicate greater arterial stiffness in the event of simultaneously elevated blood pressure, fasting plasma glucose, and waist circumferenc

Association between markers of glycemia and carotid intima-media thickness: the MARK study

Carotid intima-media thickness (C-IMT) is a reliable predictor of cardiovascular events. We Investigated the relationship between markers of glycemia and C-IMT in intermediate-risk cardiovascular patients. Methods This study analyzed 427 subjects, aged 35 to 74 years (mean, 60.3 ± 8.5 years), 55 % women, enrolled into the MARK study. Including 231 subjects defined as normal glucose, 104 subjects classified as prediabetes and 92 with type 2 diabetes mellitus. Carotid ultrasound was used to measure C-IMT and the presence of plaques. Fasting plasma glucose (mg/dl) and glycated hemoglobin (%) (HbA1c) were measured using standard enzymatic automated methods. Postprandial glucose (mg/dl) was self-measured by patients at home 2 h after meals (breakfast, lunch and dinner) for 1 day. Results The C-IMT shows a positive correlation with fasting plasma glucose, postprandial glucose and HbA1c. Multiple linear regression analysis showed a positive association between HbA1c and C-IMT, with a 0.016 mm and 0.019 mm increase in mean and maximum C-IMT per 1 % increase in HbA1c. In addition, an association between fasting plasma glucose and C-IMT was found with an increase of 0.004 and 0.005 mm in mean and maximum C-IMT per 10 mg/dl in fasting plasma glucose. We also observed a graded association between fasting plasma glucose, postprandial glucose and HbA1c and the presence of carotid target organ damage (TOD), with an odds ratio of 1.013, 1.010 and 1.425, respectively. Conclusion The results of this study suggest that the fasting plasma glucose and HbA1c, but not postprandial glucose, are associated with C-IMT media and maximum. The patients who present with a metabolic glucose alteration have more risk of developing carotid TO

Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial – EVIDENT II study

[EN]Background: Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive. Objective: To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity (PA) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention. Methods: This randomised clinical trial included 833 subjects. The counselling and app group (IG) had 415 subjects, while 418 were included in the counselling only group (CG). The primary outcome was adiposity measurements at 3 and 12 months after intervention. The secondary outcome was the effect of the intervention by sex. Intervention: Counselling on a heart-healthy diet and PA was given to both groups. The IG also received training in the use of a smartphone app designed to promote a heart-healthy diet and PA, and this group was given access to this application for 3 months. Outcome measurements included waist circumference (WC), body mass index (BMI) and Clínica Universidad de Navarra – body adiposity estimator (CUN-BAE). Results: In the IG at 12 months, the following decreased: WC −0.72 cm (95% confidence interval [CI]: −2.35 to −0.02) and CUN-BAE −0.35 (95% CI: −0.63 to −0.06). These decreases were only observed in women. After baseline adjustment, the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC (−0.67; 95% CI: −0.29 to −0.02) and CUNBAE (−0.57; 95% CI: −1.10 to −0.04), but only in women. Conclusions: An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women, but not in men.This study was funded by the Spanish Ministry of Science and Innovation (MICINN), the Carlos III Health Institute/European Regional Development Fund (ERDF) (MICINN, ISCIII/FEDER) (FIS: PI13/00618, PI13/01526, PI13/00058, PI13/01635, PI13/02528, PI12/01474; RETICS: RD12/0005, RD16/0007, RD12/0005/0001) and the Regional Health Management of Castilla and León (GRS 1191/B/15, GRS 909/B/14, GRS 770/B/13)

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial

Complex interventions; Cost-effectiveness analysis; Health behaviour; Primary health careIntervencions complexes; Anàlisi cost-efectivitat; Comportament de la salut; Atenció primàriaIntervenciones complejas; Análisis coste-efectividad; Comportamiento de la salud; Atención primariaBackground Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. Methods This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the “5A’s”. It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the “Consolidated Framework for Implementation Research”, a set of discrete implementation strategies and an evaluation framework. Discussion EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. Trial registration ClinicalTrials.gov, NCT03136211.Retrospectively registered on May 2, 2017.This project is funded by the Institute of Health Carlos III, Ministry of Economy and Competitiveness (Spain), with a grant for research projects on health (PI15/00114) through the Network for Prevention and Health Promotion in Primary Care (redIAPP, RD12/0005/0001; RD16/0007/0001), and by European Union ERDF funds, (European Regional Development Fund).This study was funded by the Health Department (SLT002/16/00112) from the Generalitat of Catalunya