Reduction in the Risk of Peripheral Neuropathy and Lower Decrease in Kidney Function with Metformin, Linagliptin or Their Fixed-Dose Combination Compared to Placebo in Prediabetes: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of glucose-lowering drugs on peripheral nerve and kidney function in prediabetes. METHODS: Multicenter, randomized, placebo-controlled trial in 658 adults with prediabetes treated for 1 year with metformin, linagliptin, their combination or placebo. Endpoints are small fiber peripheral neuropathy (SFPN) risk estimated by foot electrochemical skin conductance (FESC < 70 µSiemens) and estimated glomerular filtration rate (eGFR). RESULTS: Compared to the placebo, the proportion of SFPN was reduced by 25.1% (95% CI:16.3-33.9) with metformin alone, by 17.3% (95% CI 7.4-27.2) with linagliptin alone, and by 19.5% (95% CI 10.1-29.0) with the combination linagliptin/metformin (p < 0.0001 for all comparisons). eGFR remained +3.3 mL/min (95% CI: 0.38-6.22) higher with the combination linagliptin/metformin than with the placebo (p = 0.03). Fasting plasma glucose (FPG) decreased more with metformin monotherapy -0.3 mmol/L (95%CI: -0.48; 0.12, p = 0.0009) and with the combination metformin/linagliptin -0.2 mmol/L (95% CI: -0.37; -0.03) than with the placebo (p = 0.0219). Body weight (BW) decreased by -2.0 kg (95% CI: -5.65; -1.65, p = 0.0006) with metformin monotherapy, and by -1.9 kg (95% CI: -3.02; -0.97) with the combination metformin/linagliptin as compared to the placebo (p = 0.0002). CONCLUSIONS: in people with prediabetes, a 1 year treatment with metformin and linagliptin, combined or in monotherapy, was associated with a lower risk of SFPN, and with a lower decrease in eGFR, than treatment with placebo.

Validation of the Finnish Type 2 Diabetes Risk Score (FINDRISC) with the OGTT in Health Care Practices in Europe.

AIMS: /hypothesis. To determine the best cut-off threshold value of the Finnish Diabetes Risk Score (FINDRISC) for the detection of diabetes and non-diabetic hyperglycaemia in people 35 years or older at primary health care settings in Europe. METHODS: Cross-sectional study in 11,444 adults from primary health care centres using community and opportunistic screening approaches. All participants completed the FINDRISC questionnaire and underwent a 2-hour oral glucose tolerance test (OGTT). The FINDRISC performance was assessed by the area under the curve (AUC) using receiver operating characteristics (ROC) analysis. The sensitivity, specificity, Youdens index, positive and negative prediction values for different FINDRISC cut-offs were calculated. RESULTS: The optimal FINDRISC value for detecting both diabetes or glucose impairment in the community - screened sample was 14 point with the associated AUC 0.75,5 (95 %CI 0.73,7-0.77,3). The optimal score in the opportunistic screening sample was 16 with the associated AUC only 0.60,4 (95% CI 0.56, 4-0.64, 4). CONCLUSIONS/INTERPRETATION: The FINDRISC is a non-invasive tool useful for detecting people with unknown diabetes and glucose impairment in people visiting primary health centres in Europe.

Independent and Joint Associations Between Leisure Time Physical Activity and Strength Activities With Mortality Outcomes in Older Adults At least 65 Years of Age: A Prospective Cohort Study.

Scientific evidence regarding the combined effect of both aerobic leisure-time physical activity (LTPA) and muscle-strengthening activities on all-cause, cardiovascular disease (CVD), or cancer mortality in older adults is scant. The aim of the study was to investigate the associations between recommended physical activity and mortality in adults 65 years or older. This prospective cohort study used data from the National Health Interview Surveys from 1997 to 2013 linked with mortality files through December 31, 2015 (n = 89 962). The main outcomes included all-cause, CVD, and cancer mortality. The main exposure variables were aerobic LTPA and guideline-concordant strength training during leisure time. Cox regression models were used to calculate the hazard ratios (HRs) and the corresponding 95% confidence intervals (CIs). Muscle-strengthening activity at least twice per week were associated with lower hazards of all-cause mortality (HR 0.92; 95% CI 0.88-0.96), CVD mortality (HR 0.90; 95% CI 0.81-0.99), and cancer mortality (HR 0.87; 95% CI 0.79-0.96). Those who reached the recommended weekly amount of LTPA had a lower hazard of all-cause mortality by 35% (HR 0.66; 95% CI 0.63-0.67), the hazard of CVD by 38% (HR 0.62; 95% CI 0.58-0.67), and cancer mortality by 22% (HR 0.78; 95% CI 0.73-0.84). The hazard of death among those who were physically active in both leisure time and engaged in muscle-strengthening activities was 0.57 (95% CI 0.54-0.60) for all-cause mortality, 0.53 (95% CI 0.47-0.61) for CVD mortality, and 0.66 (95% CI 0.58-0.75) for cancer mortality. Thus, engaging in muscle-strengthening activity at least 2 times/week may provide additional benefits among physically active older adults.

Evaluación de la eficacia de los protocolos de recuperación mejorada en cirugía cardiaca. Protocolo de Ensayo Clínico Aleatorizado / Assessment of the efficacy of improved recovery protocols in cardiac surgery. Randomized Clinical Trial Protocol

Introducción: Múltiples son los artículos publicados que abordan el tema de la ciencia abierta y su importancia para la sociedad, especialmente para la comunidad de investigadores. Esta constituye, ineludiblemente, el presente y futuro de las revistas científicas como método de expandir las investigaciones con alta calidad y credibilidad. La ciencia abierta como movimiento, tiene varios componentes y dentro de ellos, la gestión de citas y referencias de datos, códigos y materiales, que fundamentan la necesidad de que los autores tengan disponibles los contenidos subyacentes a los artículos que se publican y que constituyen la base de los resultados obtenidos en cada investigación. Objetivo: Evaluación de la eficacia de los protocolos de recuperación mejorada en cirugía cardiaca. Métodos: El protocolo que se propone fue elaborado por la investigadora principal (registro público cubano de ensayos clínicos RPCEC00000304) y se describe acorde a las recomendaciones de la lista internacional de chequeo para ensayos clínicos (SPIRIT). Conclusiones: Estarían en relación a si se puede demostrar, después de terminada la investigación, si el protocolo motivo de la Intervención, es mejor, igual o peor que el protocolo de control(AU)

Introduction: There are multiple articles published that address the subject of open science and its importance for society, especially for the research community. This constitutes, inevitably, the present and future of scientific journals as a method of expanding research with high quality and credibility. Open science, as a movement, has several components including the management of citations and references of data, codes and materials, which support the need for authors to have available the underlying content of the articles published and constituting the base for the results obtained in each investigation. Objective: Assessment of the efficacy of improved recovery protocols in cardiac surgery. Methods: The proposed protocol was prepared by the main researcher (Cuban public registry of clinical trials: RPCEC00000304) and is described according to the recommendations of the international checklist for clinical trials (SPIRIT). Conclusions: They would be related to whether it can be demonstrated, after the end of the investigation, if the protocol reason for the intervention is better, equal to, or worse than the control protocol(AU)

Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.

OBJECTIVES: To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes. METHODS: Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial. PARTICIPANTS: Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey. INTERVENTION: Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function. RESULTS: One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. CONCLUSIONS: ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes. REGISTRATION: - ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39.

Factors Associated With Low Physical Activity in Two Latin American Populations at Risk of Developing Type 2 Diabetes: An Exploratory Analysis.

Low level of physical activity is a risk factor for chronic non-communicable diseases. Specifically, people at risk of Type 2 Diabetes (T2D) have shown to benefit from being physically active. The objective of this study was to explore what factors were associated with low physical activity in people at high risk of T2D living in Bogota and Barranquilla, Colombia. Methodology: Cross-sectional study using baseline data from a quasi-experimental clinical trial (PREDICOL Project). The study included 1,135 participants of Bogota and Barranquilla that presented a high risk of developing T2D according to the Finnish Diabetes Risk Score (>12 points) and who underwent an oral glucose tolerance test. The main outcome variable was the level of physical activity assessed by the International Physical Activity Questionnaire. Unadjusted and adjusted logistic regression analysis were used to calculate odds ratios (OR) and the corresponding 95% confidence intervals (CI). Results: In total, 72.5% of the study participants had low level of physical activity. Participants in the age group between 45 and 54 years showed 74% greater odds of having low physical activity compared with the youngest age group (OR 1.74, 95% CI 1.1 -2.8). People living in Barranquilla were eight times more likely to have low physical activity compared with those in Bogotá D.C. (OR 8.1, 95% CI 5.7 to 11.4). Conclusion: A large proportion of the population at risk of developing D2T in two large cities of Colombia have a sedentary lifestyle. Interventions should be designed and implemented in order to increase physical activity in these populations.

Early Lifestyle Interventions in People with Impaired Glucose Tolerance in Northern Colombia: The DEMOJUAN Project.

BACKGROUND: The objective of the demonstration project for type 2 diabetes prevention in the Barranquilla and Juan Mina (DEMOJUAN) study was to investigate the extent to which it is possible to reach normal glucose metabolism with early lifestyle interventions in people at high risk of type 2 diabetes (prediabetes), compared with those who receive standard usual care. METHODS: DEMOJUAN was a randomized controlled trial conducted in Juan Mina and Barranquilla, Northern Colombia. Eligible participants were randomized into one of three groups (control group, initial nutritional intervention, and initial physical activity intervention). The duration of the intervention was 24 months. The main study outcome in the present analysis was reversion to normoglycemia. Relative risks and their corresponding 95% confidence intervals were calculated for reversal to normoglycemia and T2D incidence. RESULTS: There was no statistically significant association between the intervention groups and reversion to normoglycemia. The relative risk of reversion to normoglycemia was 0.88 (95% CI 0.70-1.12) for the initial nutritional intervention group participants and 0.95 (95% CI 0.75-1.20) for the initial physical activity intervention group participants. CONCLUSIONS: Our study did not find any statistically significant differences in reversion to normoglycemia or the development of type 2 diabetes between the intervention groups and the control group in this population.

A demonstration area for type 2 diabetes prevention in Barranquilla and Juan Mina (Colombia): Baseline characteristics of the study participants.

Type 2 diabetes (T2D) imposes a heavy public health burden in both developed and developing countries. It is necessary to understand the effect of T2D in different settings and population groups. This report aimed to present baseline characteristics of study participants in the demonstration area for the "Type 2 Diabetes Prevention in Barranquilla and Juan Mina" (DEMOJUAN) project after randomization and to compare their fasting and 2-hour glucose levels according to lifestyle and T2D risk factor levels.The DEMOJUAN project is a randomized controlled field trial. Study participants were recruited from study sites using population-wide screening using the Finnish Diabetes Risk Score (FINDRISC) questionnaire. All volunteers with FINDRISC of ≥13 points were invited to undergo an oral glucose tolerance test (OGTT). Participant inclusion criteria for the upcoming field trial were either FINDRISC of ≥13 points and 2-hour post-challenge glucose level of 7.0 to 11.0 mmol/L or FINDRISC of ≥13 points and fasting plasma glucose level of 6.1 to 6.9 mmol/L. Lifestyle habits and risk factors for T2D were assessed by trained interviewers using a validated questionnaire.Among the 14,193 participants who completed the FINDRISC questionnaire, 35% (n = 4915) had a FINDRISC score of ≥13 points and 47% (n = 2306) agreed to undergo the OGTT. Approximately, 33% (n = 772) of participants underwent the OGTT and met the entry criteria; these participants were randomized into 3 groups. There were no statistically significant differences found in anthropometric or lifestyle risk factors, distribution of the glucose metabolism categories, or other diabetes risk factors between the 3 groups (P > .05). Women with a past history of hyperglycaemia had significantly higher fasting glucose levels than those without previous hyperglycaemia (103 vs 99 mg/dL; P < .05).Lifestyle habits and risk factors were evenly distributed among the 3 study groups. No differences were found in fasting or 2-hour glucose levels among different lifestyle or risk factor categories with the exception of body mass index, past history of hyperglycaemia, and age of ≥64 years in women. TRIAL REGISTRATION: NCT01296100 (2/12/2011; Clinical trials.gov).

Predictors of long term weight loss maintenance in patients at high risk of type 2 diabetes participating in a lifestyle intervention program in primary health care: The DE-PLAN study.

Lifestyle interventions in type 2 diabetes (DM2) prevention implementation studies can be effective and lasting. Long-term weight loss maintenance enhances the intervention effect through a significant decrease in diabetes incidence over time. Our objective was to identify factors predicting long-term successful weight reduction maintenance achieved during a DM2 prevention program in patients with high DM2 risk in primary health care. Study participants (n = 263), middle-aged, slightly obese with baseline increased DM2 risk (Finnish Diabetes Risk Score (FINDRISC)>14), but no diabetes were invited to receive 11 lifestyle counselling sessions, guided physical activity sessions and motivational support during 10-months. The study participants had three clinical examinations during the study (baseline, one and three years). Stepwise regression analysis was used to determine demographic, clinical, and lifestyle predictors of weight reduction maintenance two years after the discontinuation of the intervention. Out of 105 patients who completed all three examinations (baseline age 56.6 (standard deviation (SD) = 10.7), body mass index 31.1 kg/m2 (SD = 4.9), FINDRISC 18.6 (SD = 3.1)), 73 patients (70%) showed weight loss during the intervention (mean weight loss 4.2 kg, SD = 5.1). The total weight loss achieved in the maintainers (27 of 73 study participants) two years after the intervention had finished was 6.54 kg (4.47 kg+2.0 kg). The non-maintainers, on the other hand, returned to their initial weight at the start of the intervention (+0.21 kg). In multivariable analysis baseline history of increased glucose (odds ratio (OR) = 3.7; 95% confidence interval (CI) 1.0-13.6) and reduction of total fat in diet during follow-up (OR = 4.3; 95% CI 1.5-12.2) were independent predictors of successful weight loss. Further studies exploring predictors of weight loss maintenance in diabetes prevention are needed to help health care providers to redesign interventions and improve long-term outcomes of real life interventions.

Usefulness of the Pain Tracking Technique in Acute Mechanical Low Back Pain.

Objective. To evaluate the usefulness of the pain tracking technique in acute mechanical low back pain. Method. We performed an experimental prospective (longitudinal) explanatory study between January 2011 and September 2012. The sample was randomly divided into two groups. Patients were assessed at the start and end of the treatment using the visual analogue scale and the Waddell test. Treatment consisted in applying the pain tracking technique to the study group and interferential current therapy to the control group. At the end of treatment, cryotherapy was applied for 10 minutes. The Wilcoxon signed-rank test and the Mann Whitney test were used. They were performed with a predetermined significance level of p ≤ 0.05. Results. Pain was triggered by prolonged static posture and intense physical labor and intensified through trunk movements and when sitting and standing. The greatest relief was reported in lateral decubitus position and in William's position. The majority of the patients had contracture. Pain and disability were modified with the rehabilitation treatment in both groups. Conclusions. Both the pain tracking and interferential current techniques combined with cryotherapy are useful treatments for acute mechanical low back pain. The onset of analgesia is faster when using the pain tracking technique.

Screening for people with glucose metabolism disorders within the framework of the DEMOJUAN project (DEMOnstration area for primary prevention of type 2 diabetes, JUAN Mina and Barranquilla, Colombia).

BACKGROUND: Until now, no systematic screening for T2D or prevention activities targeting T2D has been implemented in Colombia. The aims of this study were i) describe the feasibility of implementing the Finnish Diabetes Risk Score (FINDRISC) as a screening tool for glucose metabolism disorders (GMD) in the primary health care system in Barranquilla in Colombia during 2011 and 2012, and ii) to describe the risk factors for T2D in the population screened. METHODS: This screening was opportunistic among people aged 34-60 years living in five primary health care catchment areas in Barranquilla, Colombia. People with 13 or more FINDRISC points were invited to an oral glucose tolerance test (OGTT). RESULTS: Out of 14193 participants with the FINDRISC completed, 35% (n=4915) had a score of 13 points or higher (men 23%, women 40%). Among those with FINDRISC completed, the percentage of people with BMI<25 kg/m2 was 46% in men and 35% in women. The prevalence of screen-detected T2D was 18% in men and 12% in women, respectively, among those with FINDRISC >12 attending an OGTT. In both sexes the prevalence of isolated IGT, isolated IFG, and IFG and IGT combined were 8%, 11%, and 8%, respectively. CONCLUSIONS: In total, 2% of all 14 193 screened participants had undetected T2D and 7% GMD. This figure would potentially be 4.6% (T2D), respectively 15% (GMD) if all with a FINDRISC>12 attend the OGTT. Thus, we found the FINDRISC to be a useful tool to identify people with GMD. This article is protected by copyright. All rights reserved.

Evaluación del impacto de una estrategia de intervención para reducir los recién nacidos pretérmino Policlínico Guillermo Tejas Silva / Evaluation of the Impact of an Intervention Strategy to Reduce Premature Birth at Guillermo Tejas Health Policlinic

Se realizó un estudio para evaluar el impacto de la aplicación de una estrategia de intervención, para reducir la prematuridad en el Policlínico Guillermo Tejas Silva, en el periodo comprendido de enero a diciembre del año 2012. Se utilizaron como fuente los datos emitidos del departamento de estadísticas en el periodo antes mencionado. De la base de datos de las gestantes se escogieron aquellas que tenían el riesgo de prematuridad, desde su captación hasta las 36 semanas. Se clasificaron según lo establecido por los consensos en bajo riesgo, alto riesgo y condiciones a vigilar; se trabajó con ellas en una consulta multidisciplinaria. Finalmente, se concluyó que existió impacto desde el punto de vista social, al nacer con mejor calidad de vida, ya que el recién nacido pudo estar desde el nacimiento con su mamá, recibiendo cariño, protección, confianza y seguridad. Además de un importante impacto económico, al lograr con este un ahorro de 72 030 pesos en un año, no tener la madre que ser ingresada por tiempo prolongado, como mínimo 30 días, hasta recuperar el peso del bebe y al evitar las futuras complicaciones, inherentes a la prematuridad, en el niño y su familia (AU)

A study with the objective to evaluate the impact of an intervention strategy to reduce prematurity was carried out in Guillermo Tejas Silva policlinic from January to December, 2012. The data was obtained in the statistics department. The sample was made up with the patients with prematurity risks from the time of their first visit to the 36 weeks. They were classified according to what has been established as low risk, high risk and surveillance conditions, and they were assisted in a multidisciplinary consultation. Finally, it was concluded that there was a social impact because the babies had better life quality, provided that they were with their mothers since they were born, receiving love, protection, confidence and safety. Besides, there was an important economic impact, being possible to save 72 030 pesos in one year, reducing hospitalization for the babies to gain weight in 30 days, and preventing futures complications associated to prematurity for the babies and their family (AU)

Language use depending on news frame and immigrant origin.

The purpose of this study was to analyze the effect of the media on individuals' specific language use in relation to a news story on immigration: the influence of the news frame and group cue. Abstraction, complexity of language use, and negative affective language were evaluated. The 523 participants were randomly distributed to each of the four experimental conditions: news frame (crime versus economic contribution) by group cue (geographical origin of the immigrants involved: Moroccans versus Latin Americans). Through content analysis of the ideas and reflections that arose after the participants read the different news stories, using the Linguistic Category Model (LCM; Semin & Fiedler, 1991) to measure abstract language and the Linguistic Inquiry and Word Count (LIWC; Pennebaker, Booth, & Francis, 2007) to analyze complex language and negative affective language, it emerged that abstract language and negative affective language were more frequent in the participants assigned to the news frame on crime. Complex language was more commonly used when the news frame referred to the economic contribution of immigrants. Regression analyses showed the mediating role of attitude to immigration in the effects of news frame on negative affective language. The bootstrap method was used to assess the magnitude of the indirect effect. A significant mediator effect was also found through structural equation modeling. Analyses of covariance showed one interaction between news frame and group cue: Among those who read the news story in a frame linking immigration to crime and Moroccan origin, abstract language was more characteristic. The results are discussed from the theoretical perspective of framing.