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To compare efficacy and safety of degludec 100 IU/mL (Deg-100) and glargine 300 IU/mL (Gla-300) in adults with type 1 diabetes.Open-label, single-center, randomized, parallel-group, 24-week trial in adults with type 1 diabetes, on basal-bolus insulin therapy, HbA1c ≤10%, using self-monitoring blood glucose. Participants were randomized 1:1 to a basal-bolus insulin regimen with Deg-100 (N=129) or Gla-300 (N=131). Primary efficacy endpoint: mean change in HbA1c from baseline to week-24. Main safety outcome: incidence rate of hypoglycemia during the study. Quality of life (DQoL) and satisfaction with diabetes treatment (DTSQ) were assessed.At week 24, after adjusting for baseline HbA1c, the decrease in HbA1c did not differ between groups: Deg-100 (-0.07±0.7%) and Gla-300 (-0.16±0.77%) (P=0.320). There were no significant differences between groups in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQoL, or DTSQ scores. The incidence rates of hypoglycemia3.9 mmol/L (Deg-100: 115.24 events/person-year vs. Gla-300: 99.01 events/person-year, p0.001); and3.0 mmol/L (Deg-100: 41.17 events/person-year vs. Gla-300: 34.29 events/person-year, p0.001) were different between groups.Deg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hypoglycemia, DQoL and DTSQ scores. Differences in the incidence rate of hypoglycemia3.9 mmol/L and3 mmol/L should be confirmed.

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.

Introduction MODY diabetes encompasses heterogeneous group of monogenic forms of diabetes with low prevalence. It is not easily diagnosed because of the increase in obesity and family history of diabetes in the general population. Patients and methods We present a clinical case with cardinal symptoms, diabetes,renal insufficiency with no acidosis and with a family history of diabetes and renal agenesis. Results Distinguishing MODY diabetes from DM1 and DM2 is very important to ensure optimal treatment, and because the risk of complications depends on each genetic defect. A proper diagnosis needs a detailed medical history. Discussion An earlier identification of family members at risk and a correct and individualized treatment could be possible. Many of these patients can be managed successfully in monotherapy without insulin therapy.

Resumen Introduccion La diabetes tipo MODY engloba un grupo heterogeneo de formas monogenicas de diabetes de baja prevalencia. Pacientes y metodos Presentamos un caso clinico con clinica cardinal, diabetes e insuficiencia renal sin acidosis, con antecedentes familiares de diabetes y padre monorreno. Resultados Dado el aumento de obesidad y antecedentes familiares de diabetes en la poblacion general, su sospecha diagnostica no resulta facil. Distinguir diabetes tipo MODY de DM1 y DM2 es crucial ya que el tratamiento optimo y el riesgo de complicaciones varia con el defecto genetico subyacente. Discusion Un adecuado diagnostico precisa de una historia clinica orientada y detallada, permitiendo una identificacion mas temprana de los miembros en riesgo de la familia y adecuar el tratamiento, ya que muchos de estos pacientes pueden ser tratados con exito en monoterapia retirando la insulinoterapia innecesaria.

Background Although the insulin bolus calculator is increasingly being used by people with type 1 diabetes (T1D) on multiple daily injection (MDI) therapy, few studies have investigated its effects on glycemic control. The aim of this study was to determine whether adding this device to therapeutic intensification could further improve metabolic control. Methods A 4-month randomized controlled clinical trial was performed comparing subjects undergoing therapeutic intensification and either using the bolus calculator (Cb group) or not (active control [Co] group). Metabolic control, fear of hypoglycemia, and treatment acceptance were evaluated. Results In all, 70 people completed the study (42 in the Cb group, 28 in the Co group). There was a significant decrease in HbA1c in both the Cb and Co groups (−7 mmol/mol [−0.7 %] vs −4 mmol/mol [−0.4 %], respectively). There were no significant differences in HbA1c at baseline or the end of the study, or in the decrease in HbA1c, glycemia, or changes in blood glucose levels at the end of the study between the two groups. There was a significant increase in the number of participants with good metabolic control (HbA1c

Advantages of continuous subcutaneous insulin infusion (CSII) over multiple daily injections with glargine (MDI/G) are still uncertain. We compared CSII vs. MDI/G therapy in unselected patients with type 1 diabetes using continuous glucose monitoring (CGSM). The primary end-points were glycaemic control and quality of life (QOL).A total of 45 patients with long-term diabetes and mean HbA1c values of 8.6±1.8% (70.5±15.4mmol/mol), previously treated with MDI/NPH, were switched to MDI/G for 6 months and then, unfulfilling therapy CSII indication, were randomly assigned to CSII or MDI/G for another six months. We evaluated QOL (EsDqol) and glycaemic control by measuring HbA1c levels, rate of hypoglycaemia, ketoacidosis and CGSM data.After the first phase (MDI/NPH to MDI/G) there was a significant improvement in total EsDQOL (99.72±18.38 vs. 92.07±17.65; p0.028), a 0.5% decrease in HbA1c values (8.4±1.2 vs. 7.9±0.7% [68±9.7 vs. 63±5.5mmol/mol]; p0.032), an improvement in glycaemic variability (standard deviation 66.9±14 vs. 59.4±16mg/dl; p0.05), a decrease in insulin requirements (0.87±0.29 vs. 0.80±0.25U/kg; p0.049), a decrease in number of severe hypoglycaemia episodes (0.44±0.9 vs. 0.05±0.2; p0.014), and an increase in periods of normoglycaemia measured with CGSM (15.8±10.9% vs. 23±18.4%; p0.003). Six months after randomization, significant improvements were seen in the HbA1c (7.9±0.7 vs. 7±0.6% [63±5.5 vs. 53±4.5mmol/mol]; p0.001) and EsQOL (91.66±22 vs. 84.53±1.63; p0.045) only in the CSII group. The HbA1c value was significantly lower when compared with the MDI/G group (CSII 7±0.6% [53±4.5mmol/mol] vs. MDI/G 7.6±0.9% [59.6±7.7mmol/mol]; p0.03).Intensive insulin therapy with CSII vs. MDI/G was associated with better levels of HbA1c in patients with long-term type 1 diabetes.

Introduction Few studies assessing the relationship between oxidative stress and glycemic variability in children with type 1 diabetes mellitus (T1DM) are available, and most of them reported no significant results. Objective To assess the relationship between glucose control, glycemic variability, and oxidative stress as measured by urinary excretion of 8-iso-prostanglandin F2-alpha (8-iso-PGF2α) in children with T1DM. Materials and methods A cross-sectional study including 25 children with T1DM. Participants were evaluated during five days in two different situations: 1st phase during a summer camp, and 2nd phase in their everyday life at home. The following data were collected in each study phase:. – Six capillary blood glucose measurements per day. Mean blood glucose (MBG) levels and glucose variability parameters, including standard deviation, coefficient of variation, and mean amplitude of glycemic excursions (MAGE), were calculated. – Capillary HbA1c level. – 24-h urine sample to measure 8-iso-PGF2α. Results There were no statistically significant differences in urinary 8-iso-PGF2α levels (142 ± 37 vs. 172 ± 61 pg/mg creatinine) and glucose control and glycemic variability parameters between both phases. In the 2nd phase, statistically significant correlations were found between urinary 8-iso-PGF2α and HbA1c levels (r = 0.53), MBG (r = 0.72), standard deviation (r = 0.49), and MAGE (r = 0.42). No significant correlations between glucose control, glycemic variability and urinary 8-iso-PGF2α excretion were found in the 1st phase. Conclusions A significant correlation was found between glycemic variability and HbA1c level and urinary 8-iso-PGF2α excretion in a group of children with T1DM during their daily lives. Additional studies are needed to confirm this finding and to explore its long-term impact on health.

Few prospective cohort studies have evaluated dietary iodine intake and urinary iodine concentrations in the general adult population. We assess the evolution of urinary iodine excretion and factors that may influence it in an adult population followed for 11 years.A population-based cohort study was undertaken in Pizarra (Spain). In the three study phases (baseline (n = 886), and 6 (n = 788) and 11 years later (n = 501)), participants underwent an interview and a standardized clinical examination that included a food questionnaire, and thyroid hormone and urinary iodine determinations. Subjects with thyroid dysfunction, palpable goiter or urinary iodine excretion400 μg/L were excluded.Urinary iodine increased over the years (100.6 ± 70.0 μg/L at baseline vs. 125.4 ± 95.2 μg/L at 6 years and 141.6 ± 81.4 μg/L at 11 years; p0.0001). Urinary iodine was significantly higher in subjects who reported iodized salt consumption and in subjects with a higher intake of dairy products (p0.05). Consumption of iodized salt (Risk ratio (RR) = 1.23, 95% CI [1.01-2.05]) and dairy products (RR = 2.07, 95% CI [1.01-4.23]), and a baseline urinary iodine concentration ≥100 μg/L (RR = 1.26, 95% CI [1.04-1.53]) were significantly associated with urinary iodine concentrations ≥100 μg/L at 11 years. There is no correlation between thyroid function (TSH, free triiodothyronine or free thyroxine levels) and urinary iodine concentrations in conditions of iodine sufficiency.The increase in urinary iodine concentrations over eleven years is associated with an increase in iodized salt intake and with the dairy products intake, and possibly with a higher iodine content of dairy products. However, individual variability in urinary iodine excretion was not fully explained by dietary iodine intake alone; previous urinary iodine concentrations were also important.

Resumen Introduccion En 2009, la Sociedad Andaluza de Endocrinologia y Nutricion diseno un protocolo de insulinizacion subcutanea para pacientes hospitalizados no criticos («Protocolo de insulinizacion hospitalaria para el paciente no critico» [PIH]), adoptado dentro del Sistema Sanitario Publico Andaluz. Objetivos Analizar la implementacion del PIH en hospitales de tercer nivel del Sistema Sanitario Publico Andaluz. Metodo Estudio multicentrico descriptivo transversal en 8 hospitales andaluces de tercer nivel, mediante muestreo aleatorizado de pacientes ingresados ≥ 48 h, con DM (n = 306), en 5 servicios medicos (SM) y 2 quirurgicos (SQ). La DM tipo 1, DM por trastornos especificos, soporte nutricional artificial, tratamiento esteroideo y gestacion fueron criterios de exclusion. Resultados Se incluyeron 288 pacientes (varones 62,5%; 70,3 ± 10,3 anos; 71,5% SM y 28,5% SQ). El regimen insulinico basal-bolus-correccion se instauro en el 55,9% (IC95%: 50,5-61,2%); 63,1% SM vs. 37,8% SQ (p Conclusiones Son recomendables estrategias para aumentar la implantacion del PIH, especialmente en servicios quirurgicos. Las pautas moviles de insulina rapida son la alternativa mas frecuente al regimen insulinico basal-bolus-correccion. Es preciso fomentar la valoracion del control metabolico al ingreso.

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.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-IR90th percentile, high-density lipoprotein cholesterol40 mg/dL in men and high-density lipoprotein cholesterol50 mg/dL in women, triglycerides150 mg/dL, fasting glucose110 mg/dL, and blood pressure ≤140/90 mm Hg; C: HOMA-IR90th percentile, triglycerides150 mg/dL, fasting glucose110 mg/dL, and blood pressure ≤140/90 mm Hg; D: HOMA-IR90th percentile, triglycerides150 mg/dL, and fasting glucose110 mg/dL. Subjects with T2D at baseline were excluded from the calculations of incidence of T2D.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.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.

SummaryObjective 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.

We evaluated a telemedicine system in patients with type 1 diabetes who had optimized treatment with an insulin pump and a real-time continuous glucose monitoring system. We conducted a prospective, one-year study of 15 subjects. Three medical visits took place: pre-baseline, baseline and at 6 months. Each month the subjects transmitted information from the glucose meter, glucose sensor and insulin pump. We adjusted the treatment and returned the information by email. We evaluated psychological and metabolic variables, including HbA1c, hypoglycaemia, hyperglycaemia and glucose variability. At baseline the mean age of the subjects was 40 years and the mean duration of diabetes was 22 years. There was a significant reduction in HbA1c (7.50 to 6.97%) at 6 months, a significant increase in the number of self-monitoring blood glucose checks per day (5.2 to 6.2), and significant improvements in variability: MODD, mean of daily difference (67 to 53) and MAGE, mean amplitude of glycaemic excursions (136 to 102). There were significant improvements in quality of life (92 to 87), satisfaction with the treatment (34 to 32) and less fear of hypoglycaemia (36 to 32). Adult subjects with type 1 diabetes on treatment with a continuous insulin infusion system and a real time glucose sensor and who have acceptable metabolic control and optimized treatment can benefit from the addition of a telemetry system to their usual outpatient follow-up.

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 (Malaga). 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 > 100 mg/dl and a FINDRISC 9 (OR: 19.37; 95%IC: 8,86-42,34; P < .0001).

Eur J Clin Invest 2011; 41 (11): 1202–1209 Abstract Background Different studies, mostly cross-sectional, have found an association between low levels of thyroid hormones, even within the normal range, and a greater body mass index. The aim of this study was to determine the association between thyroid function and the risk for obesity. Materials and methods In this population-based prospective study, measurements were made of anthropometric parameters, thyroid hormone function and urinary iodine in a cohort of the Pizarra Study (n = 937), and repeated 6 years later (n = 784). At the second point, measurements were also made of leptin and adiponectin. Results Among the persons who were not obese at the start of the study, the odds ratio (OR) of becoming obese for those in the fourth quartile (Q4) for free triiodothyronine (FT3) (versus those in Q1) was 2·94 (1·46–5·90) (P = 0·005). The OR of becoming obese in persons in Q4 of FT4 (versus those in Q1) was 3·06 (1·23–7·43) (P = 0·01). Those persons in Q4 of weight gain had a higher FT3 at the 6-year follow-up than those whose weight gain was in Q1 (P

Fundamento y objetivo Evaluar la hipotesis de que valores elevados de glucemia se asocian con menores valores sericos de acido urico, en 2 poblaciones independientes. Pacientes y metodo La primera poblacion procede del Estudio Pizarra, estudio prospectivo con 1.226 sujetos que se clasificaron segun su situacion metabolica tras una sobrecarga oral de glucosa. Se midieron variables antropometricas, valores basales de insulina, acido urico y resistencia a la insulina segun el Homeostasis Model Assessment (HOMA-IR). La segunda muestra procede de la base de datos del Hospital Universitario Carlos Haya (Malaga), que recoge 81.754 sucesivas peticiones analiticas de hemoglobina glucosilada (HbA1c) realizadas a lo largo de 30 meses. Resultados En el Estudio Pizarra los valores de glucosa se relacionaron con los valores de acido urico en ambos sexos. En la segunda muestra los valores de acido urico de mujeres siguieron una relacion en forma de campana con la HbA1c, incrementandose hasta valores de HbA1c del 7% y descendiendo a medida que la HbA1c aumentaba (p

Hypoglycemia is the most common adverse event associated with insulin treatment in diabetes. The consequences of hypoglycemia can be quite aversive and potentially life threatening. The physical sequelae provide ample reason for patients to fear hypoglycemia and avoid episodes. For these reasons, our purpose in this study was to develop a new measure that explores specific fear of hypoglycemia (FH) in adult patients with type 1 diabetes and to examine its psychometric properties. The instrument developed to assess FH was initially made up of 20 items, of which 18 were negative and 2 were positive, assessed on a 5-point Likert scale (1-5). This scale was completed by 229 patients with type 1 diabetes. Additionally, a structured interview and a closed question called subjective fear of hypoglycemia were included as diagnostic criteria. A factor analysis employing the principal-components method and promax rotation was carried out, resulting in a new scale composed of 15 items. Three factors (fear, avoidance, and interference) were obtained and explained 58.27% of the variance. The scale showed good internal consistency (Cronbach's α = .891) and test-retest reliability (r = .908, p < .001), as well as adequate concurrent and predictive validity. The cutoff score that provided the highest overall sensitivity and specificity was set at 28 points. The Fear of Hypoglycemia 15-item scale (FH-15) demonstrated good reliability and validity. This study suggests that the new instrument may serve as a valuable measure of specific FH for use in research and clinical practice.

The purpose of this research was to study the effects of treatment with continuous subcutaneous insulin infusion (CSII) on quality of life in patients with type 1 diabetes. A quasi-experimental pretest-posttest design was used. Thirty-seven patients were evaluated before and after receiving treatment. The Diabetes Quality of Life Questionnaire, Beck Depression Inventory-II, State-Trait Anxiety Inventory, and Multidimensional Health Locus of Control Scale were applied. Patients treated with CSII reported a significant improvement in their quality of life (better total quality of life, higher diabetes life satisfaction, and less social and vocational concerns) when compared with patients with Multiple Daily Injections. Although some limitations are described, the results of this study show some evidence of positive effect of pump therapy in patients with poor glycemic control prior to pump start.

Background and objective: In recent years, there has been an increased interest in depression and diabetes risk factors. Our objectives were 1) Study the variables associated with the presence of depression in patients with type 1 diabetes mellitus (DM1), 2) to analyze potential risk factors for depression in these patients, and 3) to study a possible explanatory model of depression scores in these patients. Patients and methods: 207 patients with DM1. We evaluated sociodemographic and biomedical variables by means of a structured interview. We assessed psychological variables by means of the Scale for Depression in Type 1 Diabetes (EDDI-1) and the Spanish version of Diabetes Quality of Life (Es DQOL). Results: Prevalence of depression was 21,7%. Variables associated with risk of depression in this sample were to be female; be unemployed; smoking; having complications of diabetes or other physical conditions; not perceiving family support or support from friends or colleagues in relation to diabetes; having a high number of weekly hyperglycemia; and a poor quality of life. A model based on previous research was obtained. This model explains a high percentage of the variability in the scores of patients in the EDDI-1. Conclusions: These results provide an empirical support to the knowledge of the risk factors associated with depression in patients with DM1. Glycemic control and quality of life have an important effect on the scores of depression in these patients, providing information for their treatment.

En el presente artículo se pretende estudiar si variables psicológicas (depresión, ansiedad-estado, ansiedad-rasgo y locus de control) y metabólicas (control glucémico e hipoglucemias graves) pueden predecir la calidad de vida de pacientes con diabetes mellitus tipo 1 (DM1). Treinta y tres pacientes con DM1 completaron una batería de tests psicológicos (DQOL, BDI, STAI y MHLC). Los resultados muestran que la depresión y la ansiedad- rasgo son buenos predictores de la calidad de vida de los pacientes con DM1. El resto de las variables (locus de control, hemoglobina glicosilada e hipoglucemias graves) no se relacionan con la calidad de vida. Estos resultados evidencian que las variables psicológicas (depresión y ansiedad-rasgo) pueden ser buenos predictores de calidad de vida en pacientes con DM1. Por tanto, según nuestros resultados, para mejorar la calidad de vida de las personas con esta enfermedad habría que promover la aplicación de tratamientos psicológicos dirigidos a reducir su sintomatología depresiva y ansiosa.

We undertook a population-based cohort study in Pizarra (Spain). Anthropometric and nutritional variables were recorded for 613 persons. The type of fat used was determined by measurement of the fatty acids contained in cooking oil. Serum fatty acid was used as a biological marker of the type of fat consumed. Obesity incidence in persons who were not obese at baseline was greater in those who consumed sunflower oil (Group 1: 41.5 (95% CI, 25.4-67.8) cases per 1000 person-years) than in those who consumed olive oil or a mixture of oils (Group 2: 17.3 (95% CI, 11.6-25.8) cases per 1000 person-years). The risk of developing obesity over 6 years, adjusted for age, sex, physical activity, smoking, instruction level, energy intake and baseline BMI, was 2.3 (95% CI, 1.06-5.02) in group 1 compared with that in group 2. The increase in the prevalence of obesity in the free-living population is associated with the type of fatty acids in the diet.

Objective The aim of this study was to undertake a prospective study of the changes in certain risk factors for cardiovascular disease occurring during menopause. Methods A longitudinal cohort study of 475 women was followed up for 6 years (Pizarra Study). The final menstrual period was defined after at least 6 months of amenorrhea. The women were classified into three groups: group 1, no menopause at either the first or second study; group 2, no menopause at the first study but menopause at the second study (6 y later); and group 3, menopause at the first study (and also at the second). The following are the main outcome measures used: age; body mass index; waist circumference; waist-to-hip ratio; skinfold thickness; arm circumference; intake of macronutrients (quantitative questionnaire); systolic and diastolic blood pressures; cholesterol, triglycerides; high-density lipoprotein cholesterol; uric acid; homeostasis model assessment of insulin resistance; and the prevalence of obesity, hypertension, type 2 diabetes mellitus, impaired glucose tolerance, and impaired fasting glucose. Results None of the cardiovascular risk factors studied changed during the passage from premenopause to postmenopause, independently of age or physical activity. Conclusions Menopause is a biological condition of the human species, for which has recently received attempts at medicalization that were not always justified. If menopause is not accompanied by any other cardiovascular risk factor independently of age, the stigma of menopause being considered a risk factor should cease. Although the results have the strength of a prospective study, the sample size forced us to consider these findings as preliminary.

El trasplante de organo solido se ha establecido como una opcion importante para el tratamiento de muchas enfermedades. La osteoporosis es una complicacion comun tras un trasplante de organo solido y esta relacionada con un incremento en la incidencia de fracturas y de la morbilidad en los receptores del trasplante. En esta presentacion se pretende revisar los factores implicados en la patogenia de esta importante complicacion, asi como la evaluacion, la prevencion y las opciones posibles de tratamiento en la osteoporosis postrasplante.

Aims To investigate the clinical efficacy and safety of insulin glargine compared with NPH insulin as basal insulin for the management of corticosteroid-induced hyperglycemia in hospitalized people with type 2 diabetes (T2DM) and respiratory disease. Materials and methods Randomized, two-arm parallel group, clinical trial undertaken from February 2011 to November 2012 on the pneumology ward of the Hospital Regional Universitario de Malaga (Spain), involving 53 participants with T2DM treated with medium/high doses of intermediate-acting corticosteroids. Participants were randomly assigned to receive one single dose of insulin glargine or NPH insulin in three equally divided doses before each meal as basal insulin within a basal–bolus insulin protocol. The intervention lasted six days or until discharge if earlier. Results No significant differences were seen between groups during the study in mean blood glucose (11.43 ± 3.44 mmol/l in glargine vs. 11.88 ± 2.94 mmol/l in NPH, p = 0.624), and measures of glucose variability (standard deviation 3.27 ± 1.16 mmol/l vs. 3.61 ± 0.99 mmol/l, p = 0.273; coefficient of variation 1.55 ± 0.33 mmol/l vs. 1.72 ± 0.39 mmol/l, p = 0.200). Results from CGM were concordant with those obtained with capillary blood glucose reading. The length of hospital stay was also similar between groups (8.2 ± 2.8 days vs. 9.8 ± 3.4 days, p = 0.166) There was a non significant trend for lower episodes of mild (4 vs. 8, p = 0.351) and severe hypoglycemia (0 vs. 3, p = 0.13) in the glargine group. Conclusions The results of this study showed that insulin glargine and NPH insulin are equally effective in a basal–bolus insulin protocol to treat glucocorticoid-induced hyperglycemia in people with T2DM on a pneumology ward.

Activation of the PPAR gamma 2 gene (PPARG2) improves the action of insulin and its lipid metabolism. We examined the association between Pro12Ala polymorphism of PPARG2, type 2 diabetes mellitus (DM2), and peripheral insulin sensitivity in a population with a high intake of oleic acid. A cross-sectional, population-based study was undertaken in Pizarra, a small town in the province of Malaga in southern Spain. A total of 538 subjects, aged 18-65 y, were selected randomly from the municipal census. All subjects underwent a clinical, anthropometrical, and biochemical evaluation, including an oral glucose tolerance test and Pro12Ala polymorphism of PPARG2. Insulin resistance was measured by homeostasis model assessment. Those subjects with the Ala-12 allele had an odds ratio for impaired fasting glucose of 0.55, for impaired glucose tolerance of 0.59, and for DM2 of 0.30. The intake of monounsaturated fatty acids (MUFA) contributed to the variance of the homeostasis model assessment insulin resistance index (HOMA IR) (P = 0.04), with a 2-way interaction between the Ala-12 allele of PPARG2 and the intake of MUFA (P = 0.005). The results suggest the existence of an interaction between Pro12Ala polymorphism of PPARG2 and dietary MUFA, such that obese people with the Ala-12 allele have higher HOMA IR values, especially if their intake of MUFA is low.

Aims Genes of the Apo AI/CIII/AIV cluster on chromosome 11 have been related to plasma lipid patterns. The close relationship between carbohydrate metabolism and lipid metabolism warrants investigation of the association between this cluster and Type 2 diabetes mellitus. We therefore examined the possible association between polymorphisms of this cluster and Type 2 diabetes mellitus as part of a study of the prevalence of diabetes and the metabolic syndrome in southern Spain. Methods A total of 1224 persons were selected randomly from the town of Pizarra in the province of Malaga, southern Spain. The sample errors for the prevalence of Type 2 diabetes mellitus and the three polymorphisms studied were all ≤ 4%. All subjects underwent phenotyping after an oral glucose tolerance test (75 g) (WHO 1998 criteria) and the XmnI and MspI polymorphisms of Apo AI and the SstI polymorphism of Apo CIII were genotyped. Results Those subjects with the mutated AA genotype of the MspI polymorphism (−75 GA) of Apo AI had a greater risk of impaired glucose tolerance [odds ratio (OR) = 1.95, CI = 1.02–3.8, P = 0.05], Type 2 diabetes mellitus, both known (OR = 7.38, CI = 1.3–39.7, P = 0.02) and unknown (OR = 3.7, CI = 1.4–9.9, P = 0.009). This risk was independent of age, sex, obesity, triglyceride level, HDL cholesterol and pattern of insulin resistance. Conclusions Pending confirmation in prospective studies, the AA genotype of the MspI polymorphism of the Apo AI gene, within the Apo A-I/C-III/A-IV cluster, seems to be a risk factor for Type 2 diabetes mellitus.

Most studies of antibodies to oxidized LDL have been undertaken in patients with different diseases and cardiovascular risk factors. However, very few studies have researched the distribution and determining factors of antibodies to oxidized LDL in the general population. A total of 1,354 persons (817 females and 537 males) aged 5-65 years were included in this study. They were selected randomly from the population census of Malaga, in southern Spain. The females had lower levels of total cholesterol and triglycerides and higher levels of HDL-cholesterol and a very significant increase (P < 0.0001) in levels of anti-oxidized LDL [low density lipoprotein modified by malondialdehyde (MDA-LDL)] antibodies but no difference in levels of immune complexes consisting of LDL and IgG antibodies (anti-LDL immune complex). Younger persons (16-35 years) had higher levels of anti-oxidized LDL (MDA-LDL) antibodies than persons older than 35 years (P = 0.05). Levels of immune complexes were significantly higher (P = 0.05) in persons aged 5-15 years than in persons older than 40 years. A very weak association was found between levels of anti-oxidized LDL (MDA-LDL) antibodies and anti-LDL immune complexes. The higher prevalence of anti-oxidized LDL (MDA-LDL) antibodies in females and young persons is in agreement with studies that found an inverse association between atherosclerosis and the level of these antibodies.

In 2009, the Andalusian Society of Endocrinology and Nutrition designed a protocol for subcutaneous insulin treatment in hospitalized non-critically ill patients (HIP).To analyze implementation of HIP at tertiary care hospitals from the Andalusian Public Health System.A descriptive, multicenter study conducted in 8 tertiary care hospitals on a random sample of non-critically ill patients with diabetes/hyperglycemia (n=306) hospitalized for ≥48 hours in 5 non-surgical (SM) and 2 surgical (SQ) departments. Type 1 and other specific types of diabetes, pregnancy and nutritional support were exclusion criteria.288 patients were included for analysis (62.5% males; 70.3±10.3 years; 71.5% SM, 28.5% SQ). A scheduled subcutaneous insulin regimen based on basal-bolus-correction protocol was started in 55.9% (95%CI: 50.5-61.2%) of patients, 63.1% SM vs. 37.8% SQ (P.05). Alternatives to insulin regimen based on basal-bolus-correction included sliding scale insulin (43.7%), diet (31.3%), oral antidiabetic drugs (17.2%), premixed insulin (1.6%), and others (6.2%). For patients previously on oral antidiabetic drugs, in-hospital insulin dose was 0.32±0.1 IU/kg/day. In patients previously on insulin, in-hospital insulin dose was increased by 17% [-13-53], and in those on insulin plus oral antidiabetic drugs, in-hospital insulin dose was increased by 26.4% [-6-100]. Supplemental insulin doses used for40 IU/day and 40-80 IU/day were 72.2% and 56.7% respectively. HbA1c was measured in 23.6% of patients (95CI%: 18.8-28.8); 27.7% SM vs. 13.3% SQ (P.05).Strategies are needed to improve implementation of the inpatient subcutaneous insulin protocol, particularly in surgical departments. Sliding scale insulin is still the most common alternative to insulin regimen based on basal-bolus-correction scheduled insulin. Metabolic control assessment during hospitalization should be encouraged.

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.

Little is known about the association between iodine and human milk composition. In this study, we investigated the association between iodine and different markers of oxidative stress and obesity-related hormones in human breast milk. This work is composed of two cross-sectional studies (in lactating women and in the general population), one prospective and one in vitro. In the cross-sectional study in lactating women, the breast milk iodine correlated negatively with superoxide dismutase (SOD), catalase, and glutathione peroxidase (GSH-Px) activities, and with adiponectin levels. An in vitro culture of human adipocytes with 1 μM potassium iodide (KI, dose similar to the human breast milk iodine concentration) produced a significant decrease in adiponectin, GSH-Px, SOD1, and SOD2 mRNA expression. However, after 2 months of treatment with KI in the prospective study, a positive correlation was found between 24-h urinary iodine and serum adiponectin. Our observations lead to the hypothesis that iodine may be a factor directly involved in the regulation of oxidative stress and adiponectin levels in human breast milk. Antioxid. Redox Signal. 20, 847–853.

The aim of the study was to analyze the association between aging and insulin resistance estimated by the homeostasis model assessment of insulin resistance (HOMA-IR). This work involved two studies: (1) the Di@bet.es study is a cross-sectional study including 4,948 subjects, comprising a representative sample of the adult Spanish population; (2) the Pizarra study is a population-based cohort study undertaken in Pizarra (Spain), in which 1,051 subjects were evaluated at baseline and 714 completed the 6-year follow-up study. Study variables included a clinical and demographic structured survey, a lifestyle survey, a physical examination, and an oral glucose tolerance test in subjects without diabetes. In the Di@bet.es study overall, an increase occurred in blood glucose until the age of 50, after which it remained stable (data adjusted for gender, body mass index, abnormal glucose regulation [AGR]). The HOMA-IR increased significantly with age (p = 0.01), due to a higher prevalence of obesity (p

Hypoglycemia is one of the main burdens for type I Diabetes Mellitus (DM I) patients. The consequences of hypoglycemia can be quite unpleasant due to the variety of disagreeable physical and psychological symptoms it triggers. The patient's previous experience with hypoglycemia episodes will condition his psychological reaction to future episodes, promoting behavioral modifications that associate with poor glycemic control and worse prognosis, and even with developing psychological disorders, leading to fear of hypoglycemia (FH). To be able to provide tailored prevention and treatment of patients with FH it is necessary to identify the risk factors in DM I patients. We developed and validated the FH-15 scale, a novel instrument to assess FH, which showed good concurrent and predictive validity in DM I patients. In this work we aim to identify the risk factors for suffering FH by detecting DM I patients with FH using the FH-15 scale and then analyzing the association of clinical and sociodemographic variables. We found that age, needing help to resolve an episode of hypoglycemia, and a perceived lack of social support are risk factors for suffering FH.

Summary Background & aim Recent studies suggest that white rice consumption increases risk of diabetes. Aim: to assess the association between white rice intake and the incidence of diabetes in a population from Southern Spain. Methods A population-based cohort study was undertaken in Pizarra, Spain. At baseline and follow-up, participants underwent an interview and a standardized clinical examination which included an oral glucose tolerance test in those subjects without known diabetes. Incidence and odds ratio (OR) for diabetes were calculated. Multivariate analysis was performed using stepwise logistical regression. Results Thirty eight percent of subjects reported rice consumption 2–3 times a week, 58.5% once or less a week, and 3.6% no rice consumption. In subjects who reported rice intake 2–3 times a week, incidence of diabetes after 6 years follow-up was 12.0%, and in those who reported once or less a week, 20.2% (p = 0.04, non adjusted). Subjects who ate rice frequently had lower risk to develop diabetes 6 years later (OR = 0.43, p = 0.04; adjusted for age, sex, obesity, and presence of impaired fasting glucose and/or impaired glucose tolerance at baseline). Conclusions A negative association was found between white rice intake in the way it is consumed in Southern Spain, and the 6 years incidence of diabetes.

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).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).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 glucose100mg/dl and a FINDRISC ≥9 (OR: 19.37; 95%IC: 8,86-42,34; P.0001).The results of our study show that FINDRISC can be a useful tool to detect subjects at high risk of diabetes in this population.

To evaluate the association between high levels of glycemia and low serum uric acid levels in two independent population-based samples.The first sample was taken from the Pizarra Study, a population-based prospective study of 1.226 persons classified according to their glycometabolic status, as measured from an oral glucose tolerance test. Variables recorded included anthropometric data, serum fasting insulin, uric acid (UA) and HOMA-IR. The second sample was obtained from the Central Laboratory Database, which includes 81,754 laboratory requests for HbA(1c) carried out over 30 months. We selected those that included measurements of UA, triglycerides and albuminuria.In the Pizarra Study, the fasting glucose levels showed a bell-shaped relation with serum UA levels in men and more especially in women (P0.0001). In the second sample, the UA levels in women showed a bell-shaped relation with HbA(1c), increasing as the HbA(1c) rose to 7% and then falling with the further increase of HbA(1c) (P0.0001). Men experienced a linear decrease in UA levels as the HbA(1c) rose (r=-0.19; P0.0001), though only with effect from HbA(1c) values7%. The odds ratio for hyperuricemia (≥ 6mg/dL in women and ≥ 7mg/dL in men) fell continuously as the HbA(1c) levels rose.This study, undertaken in two different populations, showed that serum UA levels are non-linearly correlated with the levels of glucose, HbA(1c) and HOMA-IR, especially in women. The risk of hyperuricemia and gout may be higher in persons with prediabetic states or with better-controlled diabetes than in persons with poorly-controlled diabetes.

In recent years, there has been an increased interest in depression and diabetes risk factors. Our objectives were 1) Study the variables associated with the presence of depression in patients with type 1 diabetes mellitus (DM1), 2) to analyze potential risk factors for depression in these patients, and 3) to study a possible explanatory model of depression scores in these patients.207 patients with DM1. We evaluated sociodemographic and biomedical variables by means of a structured interview. We assessed psychological variables by means of the Scale for Depression in Type 1 Diabetes (EDDI-1) and the Spanish version of Diabetes Quality of Life (Es DQOL).Prevalence of depression was 21,7%. Variables associated with risk of depression in this sample were to be female; be unemployed; smoking; having complications of diabetes or other physical conditions; not perceiving family support or support from friends or colleagues in relation to diabetes; having a high number of weekly hyperglycemia; and a poor quality of life. A model based on previous research was obtained. This model explains a high percentage of the variability in the scores of patients in the EDDI-1.These results provide an empirical support to the knowledge of the risk factors associated with depression in patients with DM1. Glycemic control and quality of life have an important effect on the scores of depression in these patients, providing information for their treatment.

Background: The intestinal fatty acid– binding protein (FABP2) is involved in the intracellular transport and metabolism of fatty acids and may affect insulin sensitivity and glucose metabolism. Objective: The objective was to study the effect of interaction between the Ala54Thr polymorphism of the FABP2 gene (FABP2) and the type of dietary cooking oil used on peripheral insulin sensitivity in a population from southern Spain. Design: The study was cross-sectional. Anthropometric measurements were obtained for 1226 persons aged 18 – 65 y selected randomly from the municipal census of Pizarra, Spain. An oral-glucosetolerance test was given to 1020 of these persons. Insulin resistance was measured by homeostasis model assessment. Samples of the cooking oil being used were taken from the kitchens of a random subset of 538 persons. Results: Persons who consumed sunflower oil and who also had the Thr54 variant had higher insulin resistance than did those who consumed olive oil (P 0.01). We detected an interaction between the Ala54Thr polymorphism and the type of oil consumed that accounted for the variance in insulin resistance (P 0.02). Conclusions: The effect of dietary fatty acids on the populational pattern of insulin resistance is not independent of the Ala54Thr polymorphism of FABP2. An interaction existed between this polymorphism and the intake of dietary fats in a population with a high intake of monounsaturated fatty acids. Am J Clin Nutr 2007;86: 1232–7.

Summary Objective Numerous genes have been associated with the risk for type 2 diabetes mellitus (DM2). In an attempt to understand how specific variants of different genes interact and intervene in the molecular and physiological mechanisms of disorders such as diabetes or insulin resistance, the search for gene–gene interactions is constantly growing. We searched for a possible interaction between two polymorphisms (Trp64Arg of ADRB3 gene and –75G/A of APOA1gene) and the risk for DM2 in a population from southern Spain. Design and methods A cross-sectional study in southern Spain of 1020 people, aged 18–65 years. All persons underwent a clinical, anthropometrical and biochemical evaluation, including an oral glucose tolerance test (OGTT). Insulin resistance was measured by homeostasis model of assessment (HOMA). The polymorphisms –75G/A of APOA1 and Trp64Arg of ADRB3 were detected by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) and real-time PCR, respectively. Results The genotype frequencies of the –75G/A polymorphism of the APOA1 gene were 62·7% GG, 25·7% GA and 11·6% AA, whereas for the Trp64Arg polymorphism of the ADRB3 gene, they were 87·5% Trp/Trp, 11·7% Trp/Arg and 0·8% Arg/Arg. Subjects with both gene variants had a greater odds ratio (OR) of having DM2 [OR = 5·5; 95% confidence interval (CI) = 1·2–23·5] than persons with one or none of the variants, after adjusting for age, sex, body mass index (BMI) and homeostasis model assessment of insulin resistance (HOMA-IR). Conclusions Joint association of allele –75A (APOA1) and allele Arg64 (ADRB3) increase the risk of DM2 in a population from southern Spain.