ViDa1: The Development and Validation of a New Questionnaire for Measuring Health-Related Quality of Life in Patients with Type 1 Diabetes

IGTPAltres ajuts: Funding was provided by the Canarian Agency for Research,Innovation and Information Society (ACIISI) (DA predoctoralfellowship TESIS20120050) and the V Guido Ruffino Grantfor Research in Therapeutic Education for Diabetes (SpanishDiabetes Society 2015)This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [(2(df =554) = 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 −0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes

Estudio de la prevalencia y caracterfsticas clínicas de la enfermedad vascular periférica asintomática en pacientes con diabetes Mellitus tipo 1

INTRODUCCIÓN Y OBJETIVOS El enfoque terapéutico de la prevención cardiovascular en la diabetes mellitus tipo 1 (DM1) se fundamenta en la evidencia de pacientes con diabetes tipo 2. El objetivo principal del presente trabajo fue estimar el perfil de aterosclerosis subclínica en pacientes asintomáticos con DM1. Objetivos secundarios fueron describir los principales factores de riesgo asociados a la arteriopatía subclínica, incluyendo su posible relación con la neuropatía cardiaca autonómica (NCA). METODOLOGÍA Tras el cálculo del tamaño muestral de acuerdo al objetivo primario, se diseñó un estudio observacional de corte transversal (clinicalTrials.gov Id: NCT02910271), con un despistaje sistemático de enfermedad arterial periférica (EAP) mediante el índice tobillo-brazo (ITB) en una cohorte de 289 pacientes asintomáticos con DM1. Un ITB patológico condujo a un examen vascular exhaustivo para confirmar EAP y/o la presencia de placas carotídeas ateroescleróticas (PCA). La NCA fue evaluada mediante la escala de Ewing y Clarke. RESULTADOS Diecisiete (6%) y 75 (26%) de los pacientes presentaron un ITB reducido (≤0,9) o aumentado (> 1,2), respectivamente. La EAP fue confirmada en 9 (53%) pacientes con un ITB reducido y en 28 (37%) pacientes con un ITB aumentado, resultando en una prevalencia de EAP asintomática del 12,8% (9,4 — 17,2). Catorce pacientes presentaron PCA [4,8% (2,9 — 7,9)], en el 64% de los casos con afectación bilateral. Consecuentemente, 46 [16% (12 — 21)] pacientes asintomáticos presentaban EAP, PCA o ambos. La prevalencia de NCA fue tres veces mayor en pacientes con ITB elevado comparado con aquellos con ITB normal [OR: 3,1 (1,7 — 5,4)]). El riesgo de NCA fue mayor en aquellos sujetos con ITB aumentado y EAP [OR: 4,5 (2,0 — 10,1)]. La NCA en > 45 años fue significativamente más prevalente en mujeres con DM1 que en hombres [68,2% (47,3 — 83,6) vs. 32,4% (19,1 — 49,2); P = 0,009], con una OR de 4,5 [1,4 — 14,1]. Los niveles de andrógenos circulantes mostraron una asociación opuesta en los parámetros de NCA de mujeres y hombres. CONCLUSIONES La arteriopatía periférica está frecuentemente infradiagnosticada en pacientes asintomáticos con DM1. Un ITB elevado en un paciente con DM1, justifica descartar la presencia de NCA, ya que su asociación es frecuente y permite identificar a pacientes de alto riesgo de EAP, con un potencial beneficio de la intensificación del tratamiento. Finalmente, el dimorfismo sexual en la presentación de complicaciones crónicas en DM1, y las posibles consecuencias terapéuticas del tratamiento de la deficiencia de andrógenos masculinos y el hiperandrogenismo femenino en la NCA en merecen investigación adicional

Sex differences and sex steroids influence on the presentation and severity of cardiovascular autonomic neuropathy of patients with type 1 diabetes

Abstract Background Sex differences characterize cardiovascular outcomes in patients with type 1 diabetes. Cardioautonomic neuropathy is a common complication of type 1 diabetes that associates increased morbi-mortality. Data regarding the interplay between sex and cardiovascular autonomic neuropathy are scarce and controversial in these patients. We aimed to address sex-related differences in the prevalence of seemingly asymptomatic cardioautonomic neuropathy in type 1 diabetes, and their associations with sex steroids. Methods We conducted a cross-sectional study including 322 consecutively recruited patients with type 1 diabetes. Cardioautonomic neuropathy was diagnosed using Ewing's score and power spectral heart rate data. We assessed sex hormones by liquid chromatography/tandem mass spectrometry. Results When considering all subjects as a whole, asymptomatic cardioautonomic neuropathy prevalence was not significantly different between women and men. When age was taken into account, the prevalence of cardioautonomic neuropathy was similar among young men and those > 50 years. However, in women > 50 years, the prevalence of cardioautonomic neuropathy doubled that of young women [45.8% (32.6; 59.7) vs. 20.4% (13.7; 29.2), respectively]. The OR of having cardioautonomic neuropathy was 3.3 higher in women > 50 years than in their younger counterparts. Furthermore, women presented more severe cardioautonomic neuropathy than men. These differences were even more marked when women were classified according their menopausal status instead of age. Peri- and menopausal women had an OR 3.5 (1.7; 7.2) of having CAN compared with their reproductive-aged counterparts [CAN prevalence: 51% (37; 65) vs. 23% (16; 32), respectively]. A binary logistic regression model (R2: 0.161; P = 0.001) displayed age > 50 years as a significant determinant of cardioautonomic neuropathy only in women. Androgens were positively associated with heart rate variability in men, and negatively in women. Accordingly, cardioautonomic neuropathy was associated with increased testosterone/estradiol ratio in women but to decreased testosterone concentrations in men. Conclusions Menopause in women with type 1 diabetes is accompanied by an increase in the prevalence of asymptomatic cardioautonomic neuropathy. This age-related excess risk of cardioautonomic neuropathy is not observed in men. Men and women with type 1 diabetes have opposite associations between circulating androgens and indexes of cardioautonomic function. Trial registration ClinicalTrials.gov Identifier: NCT04950634

Effect of Iron Depletion by Bloodletting vs. Observation on Oxidative Stress Biomarkers of Women with Functional Hyperandrogenism Taking a Combined Oral Contraceptive: A Randomized Clinical Trial

Women with functional hyperandrogenism show both increased markers of oxidative stress and a mild iron overload. Combined oral contraceptives (COC) may worsen redox status in the general population. Since iron depletion ameliorates oxidative stress in other iron overload states, we aimed to address the changes in the redox status of these women as a consequence of COC therapy and of bloodletting, conducting a randomized, controlled, parallel, open-label clinical trial in 33 adult women with polycystic ovary syndrome or idiopathic hyperandrogenism. After three months of treatment with a COC, participants were randomized (1:1) to three scheduled bloodlettings or observation for another nine months. After taking a COC, participants showed a mild decrease in their plasma electrochemical antioxidant capacity, considering fast-acting antioxidants [MD: &minus;1.51 (&minus;2.43 to &minus;0.60) &mu;C, p = 0.002], and slow-acting antioxidants [MD: &minus;1.90 (&minus;2.66 to &minus;1.14) &mu;C, p &lt; 0.001]. Women submitted to bloodletting showed a decrease in their non-enzymatic antioxidant capacity levels (NEAC) throughout the trial, whereas those individuals in the control arm showed a mild increase in these levels at the end of the study (Wilks&rsquo; &lambda;: 0.802, F: 3.572, p = 0.041). Decreasing ferritin and plasma hemoglobin during the trial were associated with worse NEAC levels. COC may impair redox status in women with functional hyperandrogenism. Decreasing iron stores by scheduled bloodletting does not override this impairment

ViDa1: The Development and Validation of a New Questionnaire for Measuring Health-Related Quality of Life in Patients with Type 1 Diabetes

IGTPAltres ajuts: Funding was provided by the Canarian Agency for Research,Innovation and Information Society (ACIISI) (DA predoctoralfellowship TESIS20120050) and the V Guido Ruffino Grantfor Research in Therapeutic Education for Diabetes (SpanishDiabetes Society 2015)This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [(2(df =554) = 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 −0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes