Major amputations in type 2 diabetes between 2001 and 2015 in Spain: regional differences.

BACKGROUND: To analyze the trend of lower extremity major amputations (MA) among patients with type 2 diabetes mellitus (T2DM) in the Regions of Spain from year 2001 until 2015. METHODS: Descriptive study of 40,392 MA. Data were obtained from the national hospital discharge database in patients with T2DM. The incidence rate was calculated in each Region, in addition to the incidence ratios (IR) between annual incidence and incidence of the year 2001. The length of hospital stay and mortality risks were analyzed using regression models adjusted for sex, age and smoking. RESULTS: The major amputations incidence rate per 100,000 person-years was 0.48 in Spain; Canary Islands showed the highest incidence (0.81). The trend was a slight decrease or stability of the incidence in all Regions except in the Canary Islands (IR2015 = 2.0 [CI95% = 1.5, 2.6]) and in Madrid (IR2015 = 0.1 [CI95% = 0.1, 0.2]). Mortality after major amputations was 10% in Spain; Cantabria suffered the highest risk of death [1.7 (CI95% = 1.4; 2.1), p < 0.001] and La Rioja the lowest risk (0.5 [CI95% = 0.2; 0.9]; p = 0.026). The longest hospital stay was registered in the Canary Islands [(CI95% = 11.4;13.3], p < 0.001)], and the shortest in the Valencian Community [(CI95% = - 7.3; - 5.8), p < 0.001)]. CONCLUSION: MA in T2DM followed a growing trend in the Canary Islands, which diverged from the downward trend in Spain. The variability of mortality and hospital stay, suggest to review the clinical management in some Regions. Sudden incidence decrease in Madrid suggests checking the record procedures of hospital discharges.

Implementation of a virtual community of practice to promote the empowerment of middle-aged people with multimorbidity: study protocol of a randomised controlled trial.

INTRODUCTION: Empowering people living with multimorbidity (multiple chronic conditions) to gain greater confidence in managing their health can enhance their quality of life. Education focused on self-management is a key tool for fostering patient empowerment and is mostly provided on an individual basis. Virtual communities of practice (VCoP) present a unique opportunity for online education in chronic condition self-management within a social context. This research aims to evaluate the effectiveness/cost-effectiveness of individualised, online self-management education compared with VCoP among middle-aged individuals living with multiple chronic conditions. METHODS AND ANALYSIS: People aged 30-60, living with ≥2 chronic conditions and receiving care in primary care (PC) centres and outpatient hospital-based clinics in Madrid and Canary Islands will enrol in an 18-month parallel-design, blinded (intervention assessment and data analysts), pragmatic (adhering to the intention-to-treat principle), individually randomised trial. The trial will compare two 12-month web-based educational offers of identical content; one delivered individually (control) and the other with online social interaction (VCoP, intervention). Using repeated measures mixed linear models, with the patient as random effect and allocation groups and time per group as fixed effects, we will estimate between-arm differences in the change in Patient Activation Measure from baseline to 12 months (primary endpoint), including measurements at 6-month and 18-month follow-up. Other outcomes will include measures of depression and anxiety, treatment burden, quality of life. In addition to a process evaluation of the VCoP, we will conduct an economic evaluation estimating the relative cost-effectiveness of the VCoP from the perspectives of both the National Health System and the Community. ETHICS AND DISSEMINATION: The trial was approved by Clinical Research Ethics Committees of Gregorio Marañón University Hospital in Madrid/Nuestra Señora Candelaria University Hospital in Santa Cruz de Tenerife. The results will be disseminated through workshops, policy briefs, peer-reviewed publications and local/international conferences. TRIAL REGISTRATION NUMBER: NCT06046326.

Incidence and mortality of cerebrovascular disease in Spain: 1,600,000 hospital admissions between 2001 and 2015.

BACKGROUND: To analyze the incidence and mortality of cerebrovascular diseases (CeVD) in Spain from 2001 to 2015. METHODS: Retrospective study of hospital incidence, hospital case fatality and population mortality, with records from the Spanish Government Statistics. Days of hospital stay and risk of death (RD) during admission were estimated adjusting for age, sex, first stroke (FS), atrial fibrillation (AF), diabetes, hypertension, and smoking. RESULTS: There were 1,662,487 stroke cases older than 15 years of age admitted to hospital (1,096,748 FS), with a national incidence = 291/105 in this period (Murcia maximum (367/105), Canary Islands minimum (238/105)). Population mortality (-50%) decreased while case fatality remained stable (-3%), despite the increase in the age of patients (+2.29 years) and the incidence (+25%). Canary Islands had the youngest patients (-3.5 years for men and -6 years for women) and the longest hospital stay (+5.1 days). Andalusia (odds ratio (OR) = 1.21 (1.19; 1.22)) and the Canaries (OR = 1.18 (1.15; 1.21)) had the highest RD. The factors associated to the highest increases in RD were FS (OR = 1.34 (95% confidence interval (CI) = 1.33-1.35)) and AF (OR = 1.30 (95% CI = 1.29-1.31)). CONCLUSION: Population mortality due to CeVD was reduced by half in Spain between 2001 and 2015, but hospital incidence increased. Andalusia and the Canary Islands had the highest RD in the country. These islands presented the lowest incidence, but their patients were younger, and their hospital stay longer. FS and AF were the factors associated with a higher RD.

Association between glycemic index, glycemic load, and fructose with insulin resistance: the CDC of the Canary Islands study.

BACKGROUND: The involvement of carbohydrates in triggering insulin resistance (IR) remains a source of controversy. AIM OF THE STUDY: To study the relation between glycemic index (GI), glycemic load (GL), and fructose with insulin resistance in a predominantly rural population in the Canary Islands. METHODS: Cross-sectional study carried out in 668 nondiabetic people aged 18-75. IR was estimated with serum glucose and C-peptide (HOMA2-IR). Nutrient intakes were obtained from a validated food frequency questionnaire. ANOVA was used to analyze nutrient distribution across quartiles of HOMA2-IR. Four multivariate nutrient density models (dependent variable: log-transformed HOMA2-IR) which differed only in the kinds of carbohydrates included were tested (Model 1: carbohydrates; Model 2: GI and then GL; Model 3: free fructose, other simple sugars and starch; Model 4: total fructose, remaining sugars and starch). RESULTS: There was no association between GI and IR. There was a direct association between GL (P < 0.001), fructose (free [P = 0.001], total [P = 0.013]), energy intake (P < 0.001), fruit fiber (<0.001), and glucose (P = 0.003) with IR. There was an inverse association between cereal (P = 0.008) and vegetable fiber (P < 0.001) and IR. Multivariate models corroborated the association of carbohydrates, GL, fructose, vegetable fiber, and energy intake with IR. The association between GL and IR disappeared when Model 2 was adjusted by total fructose intake. CONCLUSIONS: There was a direct association between fructose intake and IR. There was no relationship between GI and IR. Although a direct association of GL with IR was detected, it was attributable to the consumption of fructose.

[The waist to height ratio as an index of cardiovascular risk and diabetes]. / El cociente perímetro abdominal/estatura como índice antropométrico de riesgo cardiovascular y de diabetes.

BACKGROUND AND OBJECTIVES: To identify the anthropometric index that best detects cardiovascular risk (CVR) and type 2 diabetes (DM2) in the adult Spanish population and to determine its cut-off point. SUBJECTS AND METHODS: Cross-sectional study in the general population (n=6279). Sensitivity and specificity were estimated for the anthropometric indexes: abdominal waist, body mass index, waist to hip ratio and waist to height ratio (WtHR). The areas of these indexes under ROC curve (AUC) were obtained for the following CVR factors: high coronary risk computed with Framingham model, Hypertension, Hyperlipemia, DM2, Metabolic Syndrome (MS) and Impaired Fasting Glucose (IFG). The odds ratio, with 95% confidence interval (CI(95%)), was calculated. RESULTS: WtHR was the index showing the highest AUC for DM2 and the remaining CVR factors, varying between 0.65 (CI(95%)=0.63-0.68) for IFG in men and 0.87 (CI(95%)=0.86-0.89) for MS in women. RA/E reached the maximum sensitivity (0.91) and specificity (0.70) in SM and its optimal cut-off point was 0.55, which displayed the highest risks amongst indexes, varying from 2.30 (1.96-2.70) in IFG to 16'20 (13.68-19.20) in MS. CONCLUSIONS: RA/E is the index presenting the best ability to detect DM2 and CVR in this population, and it shows the stronger association with them. Its cut-off point, 0.55, confirms the convenience of keeping the abdominal waist to less than half the height.

[Can we prevent falls in the elderly from primary care?]. / ¿Podemos desde atención primaria prevenir las caídas en las personas mayores?

OBJECTIVE: To determine the effectiveness of multifactorial intervention by Primary Care in the prevention of falls in the elderly who had fallen the year before. DESIGN: Intervention study with a control group. SETTING: Three clinics in a rural area. SUBJECTS: 224 patients > or = 65 years, independent for mobility (113 in the intervention (IG) and 111 in the control (GC) group. INTERVENTIONS: Intervention Group. INITIAL ASSESSMENT: 1) Demographic data questionnaire, number, circumstances and consequences of falls, comorbidity and drugs. 2) Oriented examination. 3) Home risks assessment. INTERVENTIONS: referred to cardiology if arrhythmia or bradycardia, referred for eye examination if changes in acute vision, recommendation for systems support if gait or balance problems, postural measures if orthostatic hypotension, behavioural measures in urinary incontinence and recommendations to modify home risks. CONTROL GROUP: Questionnaire on: demographic data, number, circumstances and consequences of falls and medication use. They received normal medical care. RESULTS: At one year 44% of the IG and 33% in the CG fell again (P=0.123). In the sub-group with more than one fall at the beginning of the study, 63% in the IG, and 56% in CG fell again (P=0.599). There were serious consequences in 6% of the IG compared to 14% in the CG (P=0.277). CONCLUSIONS: Multifactorial intervention from primary care is not effective in reducing falls or for reducing the severity of their consequences.

Decreased Consumption of Added Fructose Reduces Waist Circumference and Blood Glucose Concentration in Patients with Overweight and Obesity. The DISFRUTE Study: A Randomised Trial in Primary Care.

The relationship between fructose intake and insulin resistance remains controversial. Our purpose was to determine whether a reduction in dietary fructose is effective in decreasing insulin resistance (HOMA2-IR). This field trial was conducted on 438 adults with overweight and obese status, without diabetes. A total of 121 patients in a low fructose diet (LFD) group and 118 in a standard diet (SD) group completed the 24-week study. Both diets were prescribed with 30-40% of energy intake restriction. There were no between-group differences in HOMA2-IR. However, larger decreases were seen in the LFD group in waist circumference (-7.0 vs. -4.8 = -2.2 cms, 95% CI: -3.7, -0.7) and fasting blood glucose -0.25 vs. -0.11 = -0.14 mmol/L, 95% CI: -0.028, -0.02). The percentage of reduction in calorie intake was similar. Only were differences observed in the % energy intake for some nutrients: total fructose (-2 vs. -0.6 = -1.4, 95% CI: -2.6, -0.3), MUFA (-1.7 vs. -0.4 = -1.3, 95% CI: -2.4, -0.2), protein (5.1 vs. 3.6 = 1.4, 95% CI: 0.1, 2.7). The decrease in fructose consumption originated mainly from the reduction in added fructose (-2.8 vs. -1.9 = -0.9, 95% CI: -1.6, -0.03). These results were corroborated after multivariate adjustments. The low fructose diet did not reduce insulin resistance. However, it reduced waist circumference and fasting blood glucose concentration, which suggests a decrease in hepatic insulin resistance.

[Framingham function estimates the risk of cardio vascular mortality more effectively than SCORE function in the population of the Canary Islands (Spain)]. / En la población Canaria, la función de Framingham estima mejor el riesgo de mortalidad cardiovascular que la función SCORE.

INTRODUCTION: To compare the performance of the Framingham and SCORE functions to estimate fatal cardiovascular events. In addition, we explored the ability of both functions to detect the risk contributed by factors not included in their equations: sedentariness, obesity, abdominal circumference, abdomen/height razón, abdomen/pelvis ratio, and excessive alcohol consumption. METHODS: We performed a cross-sectional study of 5,289 individuals aged 30 to 69 years old, recruited by random sampling of the general population of the Canary Islands. We calibrated the Framingham and SCORE functions and estimated their concordance. The cardiovascular mortality rate for the population in this age range was compared with the risk predicted by the two functions. RESULTS: Among males, the mortality rate per 100,000 inhabitants was 67.4, while the Framingham, SCORE-low and SCORE-high estimations were 80, 140, and 270, respectively. Among females, the mortality rate was 19.3 while the estimations were 30, 50, and 70, respectively. Both functions detected the increased risk contributed by the factors studied, except for sedentariness among females with SCORE, and excessive alcohol consumption with both functions. Among males, taking cut points of > or = 12%, > or = 15%, and > or = 20% for Framingham, the concordance with SCORE-low yielded Kappa values of 0.6, 0.7, and 0.5, respectively. CONCLUSIONS: The Framingham function yielded the best estimate of cardiovascular mortality rates. Only Framingham detected the cardiovascular risk contributed by sedentariness in both genders. We recommend the use of the calibrated Framingham function for this population.

[Validation of the ICE model to assess social class in the adult population]. / Validación del modelo REI para medir la clase social en población adulta.

BACKGROUND: Social class has commonly been defined by the type of employment and it is assessed as a categorical variable. However, this approach has a number of drawbacks. The objective of this article is to develop and validate a readily standardizable quantitative indicator of social class and to show its ability to measure the impact of social class as a health determinant. METHODS: In 6729 individuals we measured income, crowding index, education, occupation and employment status. Two models were adjusted to study the neighborhood, dietary pattern and health problems. RESULTS: The model that included only income, crowding index and education (ICE) yielded an indicator that correlated with age (r = -0.28; p < 0.001) and consumption of potatoes (r = -0.17; p < 0.001) and salads (r = 0.10; p < 0.001). This indicator estimated that poor social classes were at significant risk for unemployment (OR = 5,), blue collar jobs (OR = 40,9), residing in poor neighborhoods (OR = 30.2), low salad consumption (OR = 2.2) and high consumption of potatoes (OR = 4.5). They also had, especially in women, a higher risk of sedentarism (OR = 1.8), obesity (OR = 4.4), metabolic syndrome (OR = 3.4) and diabetes mellitus (OR = 2.0). CONCLUSIONS: The ICE index was valid, not based on occupation or employment status, readily standardizable, and suitable for measuring social class and its impact of on health.

Hospital Mortality in 415 798 AMI Patients: 4 Years Earlier in the Canary Islands Than in the Rest of Spain.

INTRODUCTION AND OBJECTIVES: The Canary Islands has the highest mortality from diabetes in Spain. The aim of this study was to determine possible differences in mortality due to acute myocardial infarction (AMI) during hospital admission between this autonomous community and the rest of Spain, as well as the factors associated with this mortality and the population fraction attributable to diabetes. METHODS: Cross-sectional study of hospital admissions for AMI in Spain from 2007 to 2014, registered in the Minimum Basic Data Set. RESULTS: A total of 415 798 AMI were identified. Canary Island patients (16 317) were younger than those living in the rest of Spain (63.93 ± 13.56 vs 68.25 ± 13.94; P < .001) and death occurred 4 years earlier in the archipelago (74.03 ± 11.85 vs 78.38 ± 11.10; P < .001). This autonomous community had the highest prevalence of smoking (44% in men and 23% in women); throughout Spain, AMI occurred 13 years earlier in smokers than in nonsmokers. Patients in the Canary Islands had the highest mortality rates whether they had diabetes (8.7%) or not (7.6%), and they also showed the highest fraction of AMI mortality attributable to diabetes (9.4; 95%CI, 4.8-13.6). After adjustment for type of AMI, diabetes, dyslipidemia, hypertension, smoking, cocaine use, renal failure, sex and age, the Canary Islands showed the highest risk of mortality vs the rest of Spain (OR = 1.25; 95%CI, 1.17-1.33; P < .001) and it was one of the autonomous communities showing no significant improvement in the risk of mortality due to AMI during the study period. CONCLUSIONS: Mortality due to AMI during hospital admission is higher in the Canary Islands than in the rest of Spain.

The Error of Estimated GFR in Type 2 Diabetes Mellitus.

Type 2 diabetes mellitus represents 30-50% of the cases of end stage renal disease worldwide. Thus, a correct evaluation of renal function in patients with diabetes is crucial to prevent or ameliorate diabetes-associated kidney disease. The reliability of formulas to estimate renal function is still unclear, in particular, those new equations based on cystatin-C or the combination of creatinine and cystatin-C. We aimed to assess the error of the available formulas to estimate glomerular filtration rate in diabetic patients. We evaluated the error of creatinine and/or cystatin-C based formulas in reflecting real renal function over a wide range of glomerular filtration rate (from advanced chronic kidney disease to hyperfiltration). The error of estimated glomerular filtration rate by any equation was common and wide averaging 30% of real renal function, and larger in patients with measured glomerular filtration rate below 60 mL/min. This led to chronic kidney disease stages misclassification in about 30% of the individuals and failed to detect 25% of the cases with hyperfiltration. Cystatin-C based formulas did not outperform creatinine based equations, and the reliability of more modern algorithms proved to be as poor as older equations. Formulas failed in reflecting renal function in type 2 diabetes mellitus. Caution is needed with the use of these formulas in patients with diabetes, a population at high risk for kidney disease. Whenever possible, the use of a gold standard method to measure renal function is recommended.

[Presentation of the "CDC de Canarias" cohort: objectives, design and preliminary results]. / Presentación de la cohorte "CDC de Canarias": objetivos, diseño y resultados preliminares.

BACKGROUND: The Canary Islands rank first in Spain with respect to the ischaemic heart disease and diabetes mortality rates. The Islands female population leads the country in deaths from breast cancer. The "CDC de Canarias" is a general population cohort study in order to analyse the prevalence and incidence of these diseases and the exposure to their risk factors (RF) in the adult population of the archipelago. METHODS: Prospective study with a random sampling of the general population, in which 6,729 individuals participated between 2000 and 2005 (aged 18-75). Anthropometric measurements were taken, and blood was drawn for the storage of serum and genetic samples. The following information was gathered through a questionnaire: eating habits, physical activity, personal and family medical history, exposure to occupational or environmental risk factors, smoking, etc. RESULTS: The prevalence of obesity is close to 30%, without differences between sexes, however, more male subjects were overweight than women (45 vs. 33%; p <0.001) and also presented a greater prevalence of diabetes (12 vs. 10%; p =0.005), high blood pressure (43 vs. 33%; p <0.001), excessive intake of alcohol (13 vs. 2%; p <0.001) and lack of sun protection (46 vs. 18%; p <0.001). Exposure to low levels of HDL cholesterol is more frequent in women (37 vs. 30%; p <0.001) as is also the case with a sedentary life style (71 vs. 55%; p <0.001). The exposure to the risk factors studied, including poverty, is greater in advanced age groups, except for smoking (26%) which is greater in the younger subjects. The estimate of relative risks of exposure to cardiovascular and cancer risk factors is higher in low-income social classes. CONCLUSIONS: The current adult population of the Canaries presents a high prevalence of exposure to risk factors for cardiovascular disease, diabetes and cancer, among which overweight, obesity and lack of exercise stand out particularly.

[Validation of a food intake frequency questionnaire adapted for the study and monitoring of the adult population of the Canary Islands, Spain]. / Validación de un cuestionario de frecuencia de consumo de alimentos adaptado para el estudio y seguimiento de la población adulta de las Islas Canarias.

BACKGROUND: The registering of eating habits requires a valid and reliable method. The purpose of this study is to validate the food intake frequency questionnaire, CDC-FFQ, which is an adaptation of another questionnaire, in order to assess the nutrition of the adult population of the Canary Islands. METHODS: The CDC-FFQ questionnaire was given to 1,067 individuals taken from the general population (GP) and to 106 university students, aged 19 to 30. The second group was surveyed also in three 24-hour follow-ups. The nutrients were compared according to the CDC-FFQ in the GP and university students. The correlations were estimated between the CDC-FFQ and the follow-ups for nutrients and groups of foods and the concordance of the intakes of nutrients and groups of foods in the extreme quintiles, for the university students. RESULTS: The mean values between nutrients of the CDC-FFQ between the GP, university students and the general population with university studies showed no significant differences except for vitamin B12 (p=0.004) and vitamin D (p=0.005). Correlations between the CDC-FFQ and the mean of the three follow-ups were obtained in the 0.202-0.601 range between nutrients adjusted by calories consumed in the case of the university students. By groups of foods, the correlations ranged between 0.243-0.542 for the CDC-FFQ and the follow-ups. The concordance of nutrients ranged between 39% and 100% and for groups of foods, between 41% and 100%. CONCLUSIONS: The CDC-FFQ questionnaire is valid for classifying the subjects in the relative ranges of their level of intake of foods and nutrients and, therefore, it could be useful in epidemiological studies with a diet assessment in the adult population of the Canary Islands.

Validation of DIABSCORE in screening for Type 2 Diabetes and prediabetes in Tunisian population.

AIMS: To perform a validation of DIABSCORE in a sample of Tunisian adults and find out the optimal cut-off point for screening of Type 2 diabetes (T2D) and prediabetes. METHODS: 225 adults 18-75 years and a subgroup of 138 adults (18-54 years), with undiagnosed T2D from the region of Cap-Bon, Tunisia were included in the present study. The DIABSCORE was calculated based on: age, waist/height ratio, family history of T2D and gestational diabetes. Receiver operating characteristics (ROC) curves and areas under curve (AUC) were obtained. The T2D and prediabetes prevalences odds ratios (OR) between patients exposed and not exposed to DIABSCORE≥90 and DIABSCORE≥80, respectively were calculated in both age ranges. RESULTS: For screening of T2D the best value was DIABSCORE = 90 with a highest sensitivity (Se), negative predictive value (NPV) and lower negative likelihood ratio in participants aged 18-75 yr (Se = 97%; NPV = 97%) when compared to participants aged 18-54 yr (Se = 95%; NPV = 97%); for prediabetes, the best Se and NPV were for DIABSCORE = 80 in both age groups, but it showed a disbalanced sensitivity-specificity. The ROC curves for T2D showed a similar AUC in both age ranges (AUC = 0.62 and AUC = 0.61 respectively). The ROC curves for prediabetes showed a highest AUC in those aged 18-54 years than the older ones (AUC = 0.62 and AUC = 0.57, respectively). The prevalences OR of T2D for DIABSCORE≥90 was higher than for DIABSCORE≥80 in both age ranges. Nevertheless, the prevalences OR of prediabetes for DIABSCORE≥90 was half of the detected for DIABSCORE≥80 in both age ranges. CONCLUSION: The DIABSCORE is a simple clinical tool and accurate method in screening for T2D and prediabetes in the adult Tunisian population.

Clinical applicability and cost-effectiveness of DIABSCORE in screening for type 2 diabetes in primary care.

AIMS: To evaluate the applicability and cost-effectiveness of a clinical risk score (DIABSCORE) to screen for type 2 diabetes in primary care patients. METHODS: Multicenter cross-sectional study of 10,508 adult no previously diagnosed with diabetes, in 2 Spanish regions (Canary Islands and Valencian Community). The variables comprising DIABSCORE were age, waist to height ratio, family history of diabetes and gestational diabetes. ROC curves were obtained; the diabetes prevalences odds ratios (HbA1c ≥6.5%) between patients exposed and not exposed to DIABSCORE ≥100, and to fasting blood glucose ≥126mg/dL were calculated. The opinions of both the professionals and the patients concerning DIABSCORE were collected, and a cost-effectiveness analysis was performed. RESULTS: In both regions, the valid cut-off point for diabetes (DIABSCORE=100), showed an area under the curve >0.80. The prevalences odds ratio of diabetes for DIABSCORE ≥100 was 9.5 (3.7-31.5) in Canarian and 18.3 (8.0-51.1) in Valencian; and for glucose ≥126mg/dL it was, respectively, 123.0 (58.8-259.2) and 303.1 (162.5-583.8). However, glucose ≥126mg/dL showed a low sensitivity (below 48% in both communities) as opposed to DIABSCORE ≥100 (above 90% in both regions). Professionals (100%) and patients (75%) satisfaction was greater when using DIABSCORE rather than glucose measurement for diabetes screening. The cost of each case of diabetes identified was lower with DIABSCORE ≥100 (7.6 € in Canarian and 8.3 € in Valencian) than glucose ≥126mg/dL (10.8 € and 10.5 €, respectively). CONCLUSIONS: DIABSCORE is an applicable and cost-effective screening method for type 2 diabetes in primary care.

Effectiveness of a low-fructose and/or low-sucrose diet in decreasing insulin resistance (DISFRUTE study): study protocol for a randomized controlled trial.

BACKGROUND: Research published to date on the relationship between insulin resistance (IR) and fructose consumption is scarce, has used different methods, and has yielded sometimes contradictory results. This study aims to determine whether a low-fructose and/or low-sucrose diet supervised by a physician or nurse decreases IR compared to a standard diet. METHODS/DESIGN: This field trial is located at primary care centers. The participants are adults aged 29 to 66 years, with a Body mass Index (BMI) between 29 and 40.99 kg/m2 and without diabetes. To date, 245 participants have been assigned randomly to the low-fructose diet intervention group (LFDI) at health centers in the western health service zone of Tenerife island, and 245 to the standard-diet control group (SDC) at health centers in the eastern health service zone. Recruitment is opportunistic and is carried out by physicians and nurses at participating health centers. Initially (baseline), and after 24 weeks of intervention, dietary records, physical activity, waist circumference, BMI, blood pressure, fasting blood glucose and insulin concentrations (HOMA2-IR) and lipid profile are recorded; blood glucose and insulin and lipid profile are also recorded 2 h after a 75-g glucose overload. After 48 weeks (24 weeks after the intervention), fasting blood samples are again obtained and a physical examination is performed. All tests and measures are repeated and recorded except dietary records, physical activity and oral glucose overload. Low-fructose diets are designed by calculating free and total (free + fructose associated with sucrose) fructose contents in standard diets, and removing foods with a fructose content in the highest quartile for the amounts in the standard diet. Participants in both groups are prescribed a diet that contains 30 to 40% less than the participant's energy requirements. The primary endpoint is change in HOMA2-IR between baseline and week 24, and other outcomes are change in HDL-cholesterol, LDL-cholesterol, triglycerides , waist circumference to height ratio and BMI. The secondary endpoint is change in HOMA2-IR between week 24 and week 48 together with the outcomes noted above. Comparisons between groups for variables used to indicate IR levels are done with a Student's t test for unpaired variables or the Mann-Whitney U test if the distribution is not normal. Multivariate regression models will be used to control for confounding factors not accounted for in the study design, and for independent prognostic factors. DISCUSSION: If the dietary intervention being tested, i.e., a diet low in fructose/sucrose, is able to reduce IR, the results - if translated into regular clinical practice - could provide a hitherto unavailable tool to prevent type-2 diabetes mellitus. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN41579277 . Registered retrospectively on 15 November 2016.

Inverse association of resistin with physical activity in the general population.

AIM: Resistin is a cytokine related with inflammation and ischemic heart disease. Physical activity (PA) prevents chronic inflammation and ischemic heart disease. We studied the relationship of serum concentration of resistin with HDL cholesterol, a known biomarker of PA, and with different measures of PA, in a large sample of the general adult population in the Canary Islands. METHODS: Cross-sectional study of 6636 adults recruited randomly. We analyzed the correlation of resistin and HDL cholesterol with PA (as metabolic equivalent level [MET]), and fitted the results with linear and logistic regression models using adjustment for age, alcohol consumption and smoking. RESULTS: Mean resistin level was higher in women (p<0.001), correlated inversely with age, HDL cholesterol (p<0.001) and alcohol consumption (p<0.001 in men), and correlated directly with smoking (p<0.001). Resistin correlated inversely with the duration of leisure time PA (p<0.001), leisure time MET (p<0.001) and moderate leisure time PA (p<0.001), with some differences between sexes. Men (OR = 0.78 [0.61-0.99; p<0.05]) and women (OR = 0.75 [0.61-0.92; p<0.01]) in the upper quintile of leisure time PA had a lower risk of elevated resistin. In contrast, a high degree of sedentarism was associated with an increased risk elevated resistin in women (OR = 1.24 [1.04-1.47; p<0.05] and in men (OR = 1.40 [1.01-1.82; p<0.05]). CONCLUSIONS: In our sample of the general population, resistin was inversely associated with measures and levels of PA and HDL cholesterol. The association of resistin with PA was stronger than the association of HDL cholesterol with PA, making resistin a potentially useful biomarker of PA.

Lipid and inflammatory biomarker profiles in early insulin resistance.

AIMS: To analyze the serum lipid and inflammatory biomarker profile in the early insulin resistance (e-IR). METHODS: Cross-sectional study of 5943 adults without diabetes, stratified into no IR group (C-peptide

C-peptide as a risk factor of coronary artery disease in the general population.

OBJECTIVE: To analyse the association between serum C-peptide and coronary artery disease in the general population. METHODS: Follow-up study of 6630 adults from the general population. They were stratified into group 1 (no insulin resistance: C-peptide < third tercile and glycaemia < 100 mg/dL), group 2 (initial insulin resistance: C-peptide ⩾ third tercile and glycaemia < 100 mg/dL) and group 3 (advanced insulin resistance: glycaemia ⩾ 100 mg/dL). RESULTS: After 3.5 years of follow-up, group 2 had a higher incidence of myocardial infarction (relative risk (RR) = 4.2, 95% confidence interval (CI) = 1.7-10.6) and coronary artery disease (RR = 3.5, 95% CI = 1.9-6.6) than group 1. Group 3 also had increased incidences of both diseases. In multivariable analysis of the entire population, groups 2 and 3 showed significant risks of myocardial infarction and coronary artery disease (RR > 3 and RR > 2, respectively). However, when people with diabetes were excluded, the increased risks were corroborated only in group 2 for myocardial infarction (RR = 2.8, 95% CI = 1.1-6.9; p = 0.025) and coronary artery disease (RR = 2.4, 95% CI = 1.3-4.6; p = 0.007). CONCLUSION: Elevated C-peptide is associated with the incidence of myocardial infarction and coronary artery disease in the general population. It can be an earlier predictor of coronary events than impaired fasting glucose.

Relationships between serum resistin and fat intake, serum lipid concentrations and adiposity in the general population.

AIMS: The serum resistin level is associated with the incidence of ischemic heart disease in the general population. We analyzed the associations between serum resistin and fat intake, serum lipid concentrations and adiposity in the general population. METHODS: A cross-sectional study of 6,637 randomly recruited adults was conducted. The resistin levels were measured in thawed aliquots of serum using an enzyme immunoanalysis technique. RESULTS: The resistin level exhibited a positive nonparametric correlation with saturated fat intake(p < 0.001) and an inverse correlation with adherence to the Mediterranean diet(p < 0.001), monounsaturated fat intake(p < 0.05), total serum cholesterol(p < 0.001), non-HDL cholesterol(p < 0.001), LDL cholesterol(p < 0.001), body mass index(p < 0.001), waist circumference(p < 0.001) and the waist/height ratio(p < 0.001). An elevated resistin concentration(fifth quintile) was associated with adherence to the Mediterranean diet(OR=0.82 CI95%=0.71-0.93), saturated fat intake(OR=1.34 CI95%=1.16-1.56), monounsaturated fat intake(OR=0.88 CI95%=0.78-0.99), a total cholesterol level of ≥200 mg/dL(OR=0.81 CI95%=0.72-0.91), a low HDL cholesterol level(OR=0.84 CI95%= 0.76-0.93), a high non-HDL cholesterol level(OR=0.84 CI95%=0.72-0.99), a high LDL cholesterol level(OR=0.82 CI95%=0.70-0.97) and a waist/height ratio of ≥0.55(OR=0.76 CI95%=0.67-0.85). The multivariate models corroborated the positive associations between the resistin level and saturated fat intake(p < 0.001) and serum triglycerides(p=0.004) and the inverse associations between the resistin level and adherence to the Mediterranean diet(p=0.002), total serum cholesterol(p < 0.001) and cholesterol fractions and the waist/height ratio(p=0.02). CONCLUSIONS: In the general population, the serum resistin level is associated with fat intake: positively with saturated fat intake and inversely with monounsaturated fat intake. As a consequence, the resistin level is also inversely associated with adherence to the Mediterranean diet. In addition, the resistin level is inversely associated with the serum cholesterol level and adiposity.