Development and Validation of the Depression Inventory for Type 1 Diabetes (DID-1).

People with type 1 diabetes (T1D) are more likely to have depression than the general population and their prognosis is worse. Unfortunately, the characteristics of persons with T1D lead to inadequate screening for depression in this population. To aid in the detection of depression in this population, this study was undertaken to develop a depressive symptoms assessment instrument specific to patients with T1D and to examine its psychometric properties. A total of 207 people with T1D participated in this study. The reliability of the new scale was assessed using Cronbach's alpha and the Spearman-Brown split-half coefficient. The Depression Inventory for type 1 Diabetes (DID-1), composed of 45 items on a Likert scale (1-7), shows high internal and temporal consistency, as well as adequate concurrent, convergent and discriminant validity. Factor analysis identified 7 factors (Symptoms of depression, Diminished interest, Hopelessness and dissatisfaction, Guilt, Fear, frustration and irritability, Defenselessness, and Interference in daily life) that explained 61.612% of the total variability. The cut-off score for diagnosis was set at 155 points. It was concluded that the DID-1 scale is a reliable, valid and useful tool for the assessment of depressive symptoms, eliminating the bias of other nonspecific diabetes scales.

Night-time sleep duration and the incidence of obesity and type 2 diabetes. Findings from the prospective Pizarra study.

BACKGROUND: Several recent studies have related short sleep duration with different health problems, though the results related with the risk of obesity and type 2 diabetes (T2D) are far from conclusive. The aim of this study was to investigate the association between night-time sleep duration and the incidence of obesity and T2D in a prospective study with a follow-up of 11 years. MATERIAL AND METHODS: The study comprised 1145 people evaluated in 1997-1998 and re-evaluated after 6 years and 11 years. At the three study points, subjects without known diabetes mellitus (KDM) were given an oral glucose tolerance test (OGTT). Anthropometric and biochemical variables were measured. The subjects were asked about their number of hours of night-time sleep. RESULTS: After adjustment, the OR of becoming obese was significantly higher in subjects who slept ≤ 7 hours per night, at both the 6-year follow-up (OR = 1.99; 95% CI = 1.12-3.55) and the 11-year follow-up (OR = 2.73; 95% CI = 1.47-5.04). The incidence of T2D at the 6-year follow-up in subjects without T2D at baseline was higher in those who slept ≤ 7 hours per night (OR = 1.96; 95% CI = 1.10-3.50). However, this association was not independent of obesity, weight gain or abnormal glucose regulation at baseline. At the 11-year follow-up however there was no association between night-time sleep duration and the incidence of T2D. CONCLUSIONS: The incidence of obesity over the 11-year follow-up increased in subjects with fewer hours of night-time sleep. The incidence of T2D according to the hours of night-time sleep depended on obesity and the carbohydrate metabolism phenotype.

Diabetic foot units in Spain: knowing the facts using a questionnaire.

OBJECTIVE: To ascertain the number of diabetic foot units (DFUs) in Spain, the specialists working in them, and the population covered by them. MATERIAL AND METHODS: The Spanish Group on the Diabetic Foot (SGDF) prepared and agreed a questionnaire based on the recommendations of the 2011 International Consensus on the Diabetic Foot (ICDF). From October to December 2012, the questionnaire was sent to members of three scientific societies formed by professionals involved in the care of patients with diabetes mellitus. Population coverage of the responding centers and DFUs was estimated using the 2012 population census. RESULTS: Seventy five questionnaires were received, 64 of them from general hospitals, which accounted for 13% of the general hospitals of the National Health System. It was calculated that they provided coverage to 43% of the population. Thirty four centers answered that they had a DFU. Specialized diabetic foot care was only provided to 25% of the population. The number of different professionals working at diabetic foot units was 6.3±2.7. Classification of DFUs based on their complexity was as follows: 5 basic units (14.7%), 20 intermediate units (58.8%), and 9 excellence units (26.5%). CONCLUSIONS: The number of DFUs reported in this study in Spain is low, and allow for foot care of only one out of every four patients with diabetes. Spanish health system needs to improve diabetic foot care by creating new DFUs and improving the existing ones.

Metabolically healthy but obese, a matter of time? Findings from the prospective Pizarra study.

BACKGROUND: Prospective longitudinal studies evaluating the relevance of "Metabolically Healthy but Obese" (MHO) phenotype at risk for type 2 diabetes mellitus (T2D) and cardiovascular diseases are few and results are contradictory. METHODS: As a representative of the general population, 1051 individuals were evaluated in 1997-1998 and re-evaluated after 6 years and 11 years. Subjects without known T2D were given an oral glucose tolerance test. Anthropometric and biochemical variables were measured. Four sets of criteria were considered to define MHO subjects besides body mass index ≥30 kg/m(2): A: Homeostatic Model of Assessment-Insulin Resistance Index (HOMA-IR) <90th percentile; B: HOMA-IR <90th percentile, high-density lipoprotein cholesterol >40 mg/dL in men and high-density lipoprotein cholesterol >50 mg/dL in women, triglycerides <150 mg/dL, fasting glucose <110 mg/dL, and blood pressure ≤140/90 mm Hg; C: HOMA-IR <90th percentile, triglycerides <150 mg/dL, fasting glucose <110 mg/dL, and blood pressure ≤140/90 mm Hg; D: HOMA-IR <90th percentile, triglycerides <150 mg/dL, and fasting glucose <110 mg/dL. Subjects with T2D at baseline were excluded from the calculations of incidence of T2D. RESULTS: The baseline prevalence of MHO phenotype varied between 3.0% and 16.9%, depending on the set of criteria chosen. Metabolically nonhealthy obese subjects were at highest risk for becoming diabetic after 11 years of follow-up (odds ratio = 8.20; 95% confidence interval = 2.72-24.72; P < .0001). In MHO subjects the risk for becoming diabetic was lower than in metabolically nonhealthy obese subjects, but this risk remained significant (odds ratio = 3.13; 95% confidence interval = 1.07-9.17; P = .02). In subjects who lost weight during the study, the association between MHO phenotype and T2D incidence disappeared, even after adjusting for HOMA-IR. CONCLUSIONS: The results suggest that MHO is a dynamic concept that should be taken into account over time. As a clinical entity, it may be questionable.

Factors determining weight gain in adults and relation with glucose tolerance.

OBJECTIVE: Modifications in lifestyle, diet and certain clinical events are major contributors for the high prevalence of obesity. The aim of this study was to assess factors associated with weight gain in a population of Spanish adults. DESIGN: The study was undertaken in two population-based cohorts from the north and the south of Spain (baseline and after 6 years). The Asturias Study, in the north, included 1034 persons aged 30-75 years, of whom 701 were reassessed. The Pizarra Study, in the south, included 1226 persons aged 18-65 years, of whom 783 were re-evaluated. Both studies involved a nutritional questionnaire, a physical examination and an oral glucose tolerance test (OGTT). RESULTS: During the follow-up, 32.3% of the participants lost weight, 34.5% gained fewer than 4 kg and 33.2% gained more than 4 kg. Weight gain was greater in persons younger than 50 years and in those with an initial body mass index below 30. Weight gain was associated with a greater incidence of type 2 diabetes mellitus (T2DM) and abnormal glucose tolerance, whereas weight loss in persons with these disorders was associated with a normal OGTT 6 years later. Persons who took less exercise and those who reported a higher daily calorie intake experienced greater weight gain. CONCLUSION: The longitudinal changes in weight affect the development of T2DM and abnormal glucose tolerance. The weight is a dynamic phenomenon affected by several social customs.

Validación del FINDRISC (FINnish Diabetes Risk SCore) para la predicción del riesgo de diabetes tipo 2 en una población del sur de España. Estudio Pizarra / Validation of the FINDRISC (FINnish Diabetes RIsk SCore) for prediction of the risk of type 2 diabetes in a population of southern Spain. Pizarra Study

Fundamento y objetivo: El objetivo de este estudio ha sido validar la capacidad del Finnish Diabetes Risk Score (FINDRISC) de predecir el riesgo de diabetes mellitus tipo 2 (DM2) en una población del sudeste español (estudio Pizarra). Sujetos y métodos: El Estudio Pizarra es un estudio prospectivo de base poblacional desarrollado en la población de Pizarra (Málaga). La primera fase del estudio se realizó en 1997-1998 e incluyó a 1.051 individuos de entre 18-65 años seleccionados aleatoriamente del censo municipal de la localidad. En 2003-2004 los sujetos participantes en el primer estudio fueron reevaluados. Un total de 824 individuos (78,4%) completaron esta segunda fase del estudio. En ambas fases del estudio se administró una sobrecarga oral de glucosa a todos los participantes sin diabetes conocida. Se evaluó la capacidad del FINDRISC para detectar la DM2 no diagnosticada (primera fase: estudio transversal) y en la predicción de la incidencia de DM2 (segunda fase: estudio de cohortes). Resultados: El test mostró buenos resultados tanto para detectar DM2 no diagnosticada (área bajo la curva ROC [ROC-AUC]: 0,74) como para predecir DM2 incidente (ROC-AUC: 0,75). La mejor predicción de riesgo de DM2 incidente se encontró en los sujetos con glucemia en ayunas >100mg/dl y un FINDRISC ≥9 (odds ratio [OR]: 19,37; intervalo de confianza del 95% [IC 95%]: 8,86-42,34; p<0,0001). Conclusiones: Los resultados de nuestro estudio muestran que el FINDRISC puede ser una herramienta útil para detectar sujetos con alto riesgo de diabetes en esta población (AU)

Background and objetive: The aim of this study was to validate the ability of the Finnish Diabetes Risk Score (FINDRISC) to predict the risk of DM2 in a population of south-eastern Spain (Pizarra Study).Subjects and methods: The Pizarra Study is a population-based prospective study developed in the town of Pizarra (Málaga). The first phase of the study was conducted in 1997-1998, including 1051 individuals aged 18-65 years randomly selected from the municipal census of the town. In 2003-2004 the subjects participating in the first study were reassessed. 824 individuals completed the second phase of the study (78.4%). All participants without known diabetes underwent an oral glucose tolerance test both at baseline and follow-up. We evaluated the ability of the FINDRISC to detect undiagnosed DM2 (first phase: cross-sectional study) and in predicting the incidence of DM2 (second phase: cohort study). Results: The test showed good results both to detect undiagnosed DM2 (ROC-AUC 0.74) and to predict incident DM2 (ROC-AUC 0.75). The best prediction of risk of incident DM2 was found in those subjects with fasting glucose >100mg/dl and a FINDRISC ≥9 (OR: 19.37; 95%IC: 8,86-42,34; P<.0001). Conclusions: The results of our study show that FINDRISC can be a useful tool to detect subjects at high risk of diabetes in this population (AU)

[Validation of the FINDRISC (FINnish Diabetes RIsk SCore) for prediction of the risk of type 2 diabetes in a population of southern Spain. Pizarra Study]. / Validación del FINDRISC (FINnish Diabetes Risk SCore) para la predicción del riesgo de diabetes tipo 2 en una población del sur de España. Estudio Pizarra.

BACKGROUND AND OBJECTIVE: The aim of this study was to validate the ability of the Finnish Diabetes Risk Score (FINDRISC) to predict the risk of DM2 in a population of south-eastern Spain (Pizarra Study). SUBJECTS AND METHODS: The Pizarra Study is a population-based prospective study developed in the town of Pizarra (Málaga). The first phase of the study was conducted in 1997-1998, including 1051 individuals aged 18-65 years randomly selected from the municipal census of the town. In 2003-2004 the subjects participating in the first study were reassessed. 824 individuals completed the second phase of the study (78.4%). All participants without known diabetes underwent an oral glucose tolerance test both at baseline and follow-up. We evaluated the ability of the FINDRISC to detect undiagnosed DM2 (first phase: cross-sectional study) and in predicting the incidence of DM2 (second phase: cohort study). RESULTS: The test showed good results both to detect undiagnosed DM2 (ROC-AUC 0.74) and to predict incident DM2 (ROC-AUC 0.75). The best prediction of risk of incident DM2 was found in those subjects with fasting glucose >100mg/dl and a FINDRISC ≥9 (OR: 19.37; 95%IC: 8,86-42,34; P<.0001). CONCLUSIONS: The results of our study show that FINDRISC can be a useful tool to detect subjects at high risk of diabetes in this population.

Incidence of lower limb amputations in individuals with and without diabetes mellitus in Andalusia (Spain) from 1998 to 2006.

AIMS: We studied the changes in the incidence of lower limb amputation (LLA) in Andalusia from 1998 to 2006 in the population with and without diabetes. METHODS: We undertook a retrospective study of all LLA performed in Andalusia in people aged 30 years old, with or without diabetes, between 1 January 1998 and 31 December 2006. We obtained the crude and standardized incidence rates by year, and sex for three periods: 1998-2000, 2001-2003 and 2004-2006 and calculated the RR of requiring LLA in patients with diabetes. To test for time trend, Poisson regression models were fitted. RESULTS: A total of 16,210 LLA were carried out in Andalusia, 72.6% in patients with diabetes mellitus and 66.4% in men. In the population with diabetes the standardized incidence of all LLA was found to be 344.0 per 100,000 (95% CI, 315.4-372.4) in 2004-2006. There was an estimated incidence increase for all LLA by 14% and for minor LLA by 13.6% in 2004-2006. In people with diabetes the RR increased by 31.6% as compared to the first period. CONCLUSIONS: Despite the implementation of a care plan for patients with diabetes, the incidence of LLA has not fallen in Andalusia in recent years.

Vitamin D and incidence of diabetes: a prospective cohort study.

BACKGROUND & AIMS: To investigate the relationship between levels of 25-hydroxyvitamin D and the incidence of type 2 diabetes in a Spanish population. METHODS: We undertook a population-based prospective study in a population from southern Spain. The first phase of the study (1996-1998) included 1226 individuals. Of this original cohort, 988 persons were reassessed in 2002-2004 and 961 in 2005-2007. Measurements were made of 25-hydroxyvitamin D and intact parathyroid hormone in 2002-2004 and an oral glucose tolerance test was done in three time points. RESULTS: The incidence of diabetes in subjects with 25-hydroxyvitamin D levels ≤ 18.5 ng/mL (percentile 25) was 12.4% vs 4.7% in subjects with levels >18.5 ng/mL. The likelihood of having diabetes during the four years of follow-up was significantly lower in the subjects with higher levels of 25-hydroxyvitamin D [OR = 0.17 (0.05-0.61)]. None of the subjects with levels higher than 30 ng/mL developed diabetes. CONCLUSION: In this prospective study, we found a significant inverse association between serum 25-hydroxyvitamin D levels and the risk for type 2 diabetes in a population from the south of Spain.

ELOVL6 genetic variation is related to insulin sensitivity: a new candidate gene in energy metabolism.

BACKGROUND: The elongase of long chain fatty acids family 6 (ELOVL6) is an enzyme that specifically catalyzes the elongation of saturated and monounsaturated fatty acids with 12, 14 and 16 carbons. ELOVL6 is expressed in lipogenic tissues and it is regulated by sterol regulatory element binding protein 1 (SREBP-1). OBJECTIVE: We investigated whether ELOVL6 genetic variation is associated with insulin sensitivity in a population from southern Spain. DESIGN: We undertook a prospective, population-based study collecting phenotypic, metabolic, nutritional and genetic information. Measurements were made of weight and height and the body mass index (BMI) was calculated. Insulin resistance was measured by homeostasis model assessment. The type of dietary fat was assessed from samples of cooking oil taken from the participants' kitchens and analyzed by gas chromatography. Five SNPs of the ELOVL6 gene were analyzed by SNPlex. RESULTS: Carriers of the minor alleles of the SNPs rs9997926 and rs6824447 had a lower risk of having high HOMA_IR, whereas carriers of the minor allele rs17041272 had a higher risk of being insulin resistant. An interaction was detected between the rs6824447 polymorphism and the intake of oil in relation with insulin resistance, such that carriers of this minor allele who consumed sunflower oil had lower HOMA_IR than those who did not have this allele (P = 0.001). CONCLUSIONS: Genetic variations in the ELOVL6 gene were associated with insulin sensitivity in this population-based study.

Soluble fibre (Plantago ovata husk) reduces plasma low-density lipoprotein (LDL) cholesterol, triglycerides, insulin, oxidised LDL and systolic blood pressure in hypercholesterolaemic patients: A randomised trial.

UNLABELLED: The objective was to evaluate whether the soluble fibre Plantago ovata (Po)-husk improves cardiovascular disease (CVD) risk biomarkers including low-density lipoprotein cholesterol (LDL-C). METHODS: In a multi-centred, double-blind, placebo-controlled, parallel, randomised trial conducted in primary care-clinics in Spain, France and Holland, mild-moderate hypercholesterolaemic patients (age range: 43-67 years) received 14 g/d of Po-husk (n=126) or placebo (microcrystalline-cellulose 14 g/d; n=128) in a low saturated fat diet for 8 weeks. Subsequently, if LDL-C remained > or = 3.35 mmol/L [130 mg/dL], participants proceeded with the fibre plus simvastatin (20mg/d) for further 8 weeks. Lipid profile, blood pressure (BP), insulin, oxidised LDL and some gene polymorphisms involved in CVD risk were measured. RESULTS: Relative to placebo, Po-husk reduced plasma LDL-C by -6% (P<0.0002), total cholesterol (TC) by -6%, triglycerides (TG) by -21.6%, apolipoprotein (Apo) B-100 by -6.7%, oxidised LDL by a mean of -6.82 U/L (95%CI: 3.15-10.48), insulin by -4.68 pmol/L (95%CI: 0.68-8.67) and systolic BP by -4.0mm Hg (95%CI; 1.2-6.7) (P<0.05). The TG-lowering effect in the Po-husk group was magnified by variants in plasminogen-activator-inhibitor (PAI-1; rs1799768) and fatty acid-binding protein (FABP-2; rs1799883) genes. At 16 weeks, the intra-group action of simvastatin (20mg/d) added to Po-husk or placebo was a similar LDL-C reduction. CONCLUSIONS: Po-husk, apart from lowering LDL-C, also reduced TG, TG related to certain gene variants, TC, Apo B-100, oxLDL, insulin-resistance and systolic BP in mild-moderate hypercholesterolaemic individuals. Thus, the target patients to receive Po-husk would be those who present a cluster of various CVD risk factors, such as metabolic syndrome.