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BACKGROUND: Mesenchymal stem cell infusion and vitamin D supplementation may have immunomodulatory actions that could prolong the preservation of residual insulin secretion in patients with type 1 diabetes (T1D). Intervention with these agents after onset of T1D could favor the development of a remission phase, with potential clinical impact. We aimed to compare the presence of clinical remission (CR), glycemic control and daily insulin requirement at 6, 12, 18, 24 and 36 months after the diagnosis of T1D using IDAA1c in patients who received therapy with adipose tissue-derived mesenchymal stem cell (ASC) infusion and vitamin D supplementation and a control group. METHODS: This retrospective cohort study analyzed data from the medical records of patients with T1D diagnosed between 15 and 40 years. Partial CR was defined as an IDAA1c index < 9. Patients in the intervention group received an infusion of adipose tissued-derived mesenchymal stem cells (ASCs) within 3 months after diagnosis and supplementation with 2000 IU of cholecalciferol for 1 year, started on the day following the infusion. Partial CR was also determined using the ISPAD criteria, to assess its agreement with IDAA1c. RESULTS: A total of 28 patients were evaluated: 7 in the intervention group (group 1) and 21 in the control group (group 2). All patients in group 1 evolved with partial CR while only 46.7% of patients in group 2 had this outcome. Group 1 had a higher frequency of CR when evaluated with IDAA1c and ISPAD criteria. The mean duration of CR varied between the two criteria. Although HbA1c was similar between groups during follow-up, group 1 had a lower total daily insulin requirement (p < 0.005) at all time points. At 36 months, group 1 used 49% of the total daily insulin dose used by group 2 with similar glycemic control. CONCLUSION: The intervention with infusion of ASC + vitamin D supplementation was associated with partial CR at 6 months. Although there were no differences in CR established by the IDAA1c and ISPAD criteria after three years of follow-up, patients who underwent intervention had nearly the half insulin requirement of controls with conventional treatment, with similar glycemic control. TRIAL REGISTRATION: 37001514.0.0000.5257.

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To evaluate safety and therapeutic effect along 12 months of allogenic adipose tissue-derived stromal/stem cells (ASCs) transplantation with cholecalciferol (VITD) in patients with recent-onset type 1 diabetes (T1D). Prospective, phase II, open trial, pilot study in which patients with recent onset T1D received ASCs (1xKgx106 cells) and VITD 2000UI/day for 12 months (group 1) and were compared to controls with standard insulin therapy (group 2). Adverse events, C-peptide area under the curve (CPAUC), insulin dose, HbA1c and frequency of FoxP3+ in CD4+ or CD8+ T-cells(flow cytometry) were evaluated at baseline(T0), after 3(T3), 6(T6) and 12 months(T12). Eleven patients completed follow up (7:group 1;4:group 2). Group 1 had lower insulin requirement at T3(0.24±0.18vs0.53±0.23UI/kg,p=0.04), T6(0.24±0.15vs0.66±0.33 UI/kg,p=0.04) and T12(0.39±0.15vs0.74±0.29 UI/Kg,p=0.04).HbA1c was lower at T6 (50.57±8.56vs72.25±10.34 mmol/mol,p=0.01), without differences at T12 (57.14±11.98 in group 1 vs. 73.5±14.57 mmol/min in group 2, p=0.16). CPAUC was not significantly different between groups at T0(p=0.07), higher in group 1 at T3(p=0.04) and T6(p=0.006), but similar at T12(p=0.23). IDAA1c was significantly lower in group 1 than group 2 at T3,T6 and T12 (p=0.006, 0.006 and 0.042, respectively). IDDA1c was inversely correlated to FoxP3 expression in CD4 and CD8+ T cells at T6 (p<0.001 and p=0.01, respectively). In group 1, one patient had recurrence of a benign teratoma that was surgically removed, not associated to the intervention. ASCs with VITD without immunosuppression were safe and associated lower insulin requirements, better glycemic control, and transient better pancreatic function in recent onset T1D, but the potential benefits were not sustained.

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Este estudo objetivou adaptar e apresentar evidências de validade de construto, convergente e discriminante da Academic and Athletic Identity Scale para o contexto brasileiro. Participaram da pesquisa 303 estudantes universitários brasileiros (M =23,33 anos, DP = 4,605). A amostra respondeu a um questionário sociodemográfico, Escala de Identidade Acadêmica e Atlética, Escala de Identidade Profissional e Escala Flourishing. A análise fatorial confirmatória evidenciou que a versão brasileira da AAIS reproduziu integralmente a estrutura original do instrumento. As dimensões identidade acadêmica e identidade atlética apresentaram correlação significativa entre si (r = 0,205, p<0,001). A dimensão identidade acadêmica apresentou correlação significativa com identidade profissional (r = 0,354, p<0,001) e flourishing (r = 0,269, p<0,001), enquanto a identidade atlética não apresentou correlação significativa com a identidade profissional e flourishing. Os resultados evidenciaram propriedades psicométricas da AAIS-Br que recomendam seu uso em investigações destinadas a avaliar o grau da identificação com os papéis acadêmico e atlético de estudantes universitários brasileiros que praticam esportes. (AU)

This study aimed to adapt and present evidence of construct, convergent, and discriminant validity of the Academic and Athletic Identity Scale for the Brazilian context. A total of 303 Brazilian university students participated in the research (M=23.33 years, SD=4.60). The sample completed a sociodemographic questionnaire, the Academic and Athletic Identity Scale, the Professional Identity Scale, and the Flourishing Scale. Confirmatory factorial analysis showed the Brazilian version of the AAIS fully reproduced the original structure of the instrument. The dimensions academic identity and athletic identity showed a significant correlation between them (r=0.205, p<0.001). The academic identity dimension also showed significant correlation with professional identity (r=0.354, p<0.001) and flourishing (r=0.269, p<0.001), while athletic identity did not show any significant correlation with professional identity and flourishing. The results showed that the psychometric properties of the AAIS-Br recommend its use in investigations to evaluate the degree of identification with academic and athletic roles in Brazilian university student-athletes. (AU)

Este estudio tuvo como objetivo adaptar y presentar evidencias de validez de constructo, convergente y discriminante de la Academic and Athletic Identity Scale para el contexto brasileño. Participaron de la investigación 303 estudiantes universitarios brasileños (M=23,33 años, DS=4,605). La muestra respondió a un cuestionario sociodemográfico, a la Escala de Identidad Académica y Deportiva, a la Escala de Identidad Profesional y a la Escala Flourishing. El análisis factorial confirmatorio evidenció que la versión brasileña de AAIS reproducía completamente la estructura original del instrumento. Las dimensiones de identidad académica y deportiva presentaron una correlación significativa entre ellas (r=0,205, p<0,001). La dimensión identidad académica presentó correlación significativa con identidad profesional (r=0,354, p<0,001) y flourishing (r=0,269, p<0.001), mientras que la identidad deportiva no presentó ninguna correlación significativa con la identidad profesional y flourishing. Los resultados mostraron propiedades psicométricas de AAIS-Br que recomiendan su uso en investigaciones destinadas a evaluar el grado de identificación con roles académicos y deportivos en universitarios brasileños que practican deportes. (AU)

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ABSTRACT Objective: Adipose tissue-derived stromal/stem cells (ASCs) and vitamin D have immunomodulatory actions that could be useful for type 1 diabetes (T1D). We aimed in this study to investigate the safety and efficacy of ASCs + daily cholecalciferol (VIT D) for 6 months in patients with recent-onset T1D. Materials and methods: In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 x 106 cells/kg) and cholecalciferol 2,000 UI/day for 6 months (group 1). They were compared to patients who received chol-ecalciferol (group 2) and standard treatment (group 3). Adverse events were recorded; C-peptide (CP), insulin dose and HbA1c were measured at baseline (T0), after 3 (T3) and 6 months (T6). Results: In group 1 (n = 7), adverse events included transient headache (all), mild local reactions (all), tachycardia (n = 4), abdominal cramps (n = 1), thrombophlebitis (n = 4), scotomas (n = 2), and central retinal vein occlusion at T3 (n = 1, resolution at T6). Group 1 had an increase in basal CP (p = 0.018; mean: 40.41+/-40.79 %), without changes in stimulated CP after mixed meal (p = 0.62), from T0 to T6. Basal CP remained stable in groups 2 and 3 (p = 0.58 and p = 0.116, respectively). Group 1 had small insulin requirements (0.31+/- 0.26 UI/kg) without changes at T6 (p = 0.44) and HbA1c decline (p = 0.01). At T6, all patients (100%; n = 7) in group 1 were in honeymoon vs 75% (n = 3/4) and 50% (n = 3/6) in groups 2 and 3, p = 0.01. Conclusions: Allogenic ASC + VIT D without immunosuppression was safe and might have a role in the preservation of β-cells in patients with recent-onset T1D. ClinicalTrials.gov: NCT03920397.

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OBJECTIVE: Adipose tissue-derived stromal/stem cells (ASCs) and vitamin D have immunomodulatory actions that could be useful for type 1 diabetes (T1D). We aimed in this study to investigate the safety and efficacy of ASCs + daily cholecalciferol (VIT D) for 6 months in patients with recent-onset T1D. METHODS: In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 × 106 cells/kg) and cholecalciferol 2,000 UI/day for 6 months (group 1). They were compared to patients who received chol-ecalciferol (group 2) and standard treatment (group 3). Adverse events were recorded; C-peptide (CP), insulin dose and HbA1c were measured at baseline (T0), after 3 (T3) and 6 months (T6). RESULTS: In group 1 (n = 7), adverse events included transient headache (all), mild local reactions (all), tachycardia (n = 4), abdominal cramps (n = 1), thrombophlebitis (n = 4), scotomas (n = 2), and central retinal vein occlusion at T3 (n = 1, resolution at T6). Group 1 had an increase in basal CP (p = 0.018; mean: 40.41+/-40.79 %), without changes in stimulated CP after mixed meal (p = 0.62), from T0 to T6. Basal CP remained stable in groups 2 and 3 (p = 0.58 and p = 0.116, respectively). Group 1 had small insulin requirements (0.31+/- 0.26 UI/kg) without changes at T6 (p = 0.44) and HbA1c decline (p = 0.01). At T6, all patients (100%; n = 7) in group 1 were in honeymoon vs 75% (n = 3/4) and 50% (n = 3/6) in groups 2 and 3, p = 0.01. CONCLUSION: Allogenic ASC + VIT D without immunosuppression was safe and might have a role in the preservation of ß-cells in patients with recent-onset T1D. ClinicalTrials.gov: NCT03920397.

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The contemporary work context is characterized by unpredictability, thus requiring the ability of individuals to adapt to changes imposed by the market. Career adaptability refers to the individual's ability to handle working transitions in turbulent times. This study aimed to test the structural invariance of the last Brazilian version of the Career Adapt-Abilities Scale (CAAS) according to sex and observe possible differences between men and women in the dimensions of adaptability. The sample consisted of 599 Brazilian professionals, of both sexes, with higher education level. The CAAS was subject to confirmatory factor analysis and invariance testing, demonstrating structural invariance according to sex. A subsequent MANOVA evidenced the lack of differences between men and women in the four dimensions of the CAAS. Results corroborate the consistency and reliability of the CAAS as an instrument for measuring career adaptability in both sexes. (AU)

O contexto laboral contemporâneo caracteriza-se por imprevisibilidade, exigindo do indivíduo capacidade de adaptação a mudanças impostas pelo mercado. A adaptabilidade de carreira refere-se à capacidade do indivíduo de lidar com transições profissionais e situações de turbulência. Este estudo objetiva testar a invariância estrutural da última versão brasileira da Escala de Adaptabilidade de Carreira (EAC) em função do sexo e observar possíveis diferenças entre homens e mulheres nas dimensões de adaptabilidade. Participaram 599 profissionais brasileiros, de ambos os sexos, com educação superior. A EAC foi sujeita a análise fatorial confirmatória e a teste de invariância, tendo sido confirmada a sua invariância estrutural em função do sexo. Uma MANOVA subsequente evidenciou ausência de diferenças entre homens e mulheres nas quatro dimensões da EAC. Os resultados corroboram a consistência e a confiabilidade da EAC como um instrumento para medir a adaptabilidade de carreira em ambos os sexos. (AU)

El contexto laboral contemporáneo se caracteriza por imprevisibilidad, exigiendo del individuo capacidad de adaptación a cambios impuestos por el mercado. La adaptación de la carrera se refiere a la capacidad del individuo de lidiar con transiciones profesionales y situaciones de turbulencia. Este estudio tiene como objetivo testar la invariancia estructural de la última versión brasileña de la Escala de Adaptabilidad de Carrera (EAC) en función del sexo y observar posibles diferencias entre hombres y mujeres en las dimensiones de adaptación. La muestra fue compuesta por 599 profesionales brasileños, de ambos sexos, con educación universitaria. La EAC fue sometida a análisis factorial confirmatorio, y al test de invariancia, siendo confirmada su invariancia estructural en función del sexo. Posterior realización de MANOVA evidenció la ausencia de diferencias entre hombres y mujeres en las cuatro dimensiones de la EAC. Los resultados corroboraron la consistencia y confiabilidad de la EAC como un instrumento de medida de adaptación de la carrera en ambos sexos. (AU)

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No contexto escolar, habilidades sociais de professores e crianças, assim como problemas de comportamento concorrem para o desenvolvimento social e a aprendizagem dos alunos, verificando-se carência de instrumento que avalie de modo integrado tais variáveis. Com tal propósito, objetiva-se apresentar o instrumento RE-HSE-Pr e sua validação. O RE-HSE-Pr foi elaborado na mesma racional de instrumento já aferido, tendo os pais como fonte de informação, e sua apresentação após validação é de nove perguntas guias, organizadas em três eixos: Comunicação, Afeto e Estabelecimento de limites. Participaram da amostra os professores de 283 crianças pré-escolares e escolares que responderam ao RE-HSE-Pr e ao Teacher's Report Form. Procedeu-se, conforme as metodologias técnicas, as avaliações das validades de construto e discriminante e fidedignidade. Identificaram-se dois fatores (total positivo; total negativo), com alfa adequado e as análises discriminantes diferenciaram casos de não casos, meninos de meninas, pré-escolares de escolares. Os indicadores psicométricos foram satisfatórios. (AU)

In the school context, social skills in teachers and children, as well as child behavioral problems, contribute to the social development and learning of the students, however, there is no instrument that evaluates these variables in an integrated way. Therefore, the aim was to investigate the validation of the Interview Script of Educational Practices for Teachers (RE-HSE-Pr) instrument. The RE-HSEPr was developed in a similar way to other pre-existing instruments in which parents are the information source. After validation, it had 9 guide-questions organized on three information axes: Communication, Affection and Establishment of Limits. Participants were teachers of 283 pre-school and school age children, who answered both the RE-HSE-Pr and Teacher's Report Form (TRF). Evaluations of the construct and discriminant validity and reliability were performed, according to technical procedures. Two factors with adequate alpha (positive total; negative total) were identified, and discriminant analyses discriminated cases from non-cases; boys from girls and pre-school children from school children. Psychometric indicators were satisfactory. (AU)

En el contexto escolar, las habilidades sociales de profesores y niños, así como problemas de conducta, concurren para el desarrollo social y el aprendizaje de los alumnos, comprobando carencia de un instrumento que evalúe de modo integrado tales variables. Con este propósito, se pretende presentar el instrumento RE-HSE-Pr y su validación. El RE-HSE-Pr fue elaborado de igual modo que el instrumento ya evaluado teniendo los padres como fuente de información. Su presentación, después de la validación, es de 9 preguntas guías, organizadas en tres ejes: Comunicación, Afecto y Establecimiento de límites. Participaron de la muestra profesores de 283 niños preescolar y escolares que respondieron al RE-HSE-Pr y al Teacher's Report Form (TRF). Se procedió según los procedimientos técnicos, las evaluaciones de la validez de constructo y discriminante y fiabilidad. Se identificó dos factores (total positivo, total negativo), con alfa adecuado y los análisis discriminantes diferenciaron casos de no casos, niños de niñas, preescolares de escolares. Los indicadores psicométricos fueron satisfactorios. (AU)

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OBJECTIVE: Roux-en-Y gastric bypass (RYGB) reduces body weight and the comorbidities associated with obesity. The aim of this study was to evaluate whether glucose and lipid profiles were maintained during a 5-year follow-up period after RYGB. SUBJECTS AND METHODS: Anthropometric and laboratory data from 323 patients who had undergone this operation were analyzed. Differences in laboratory variables between the baseline and 12, 24, 36, 48 and 60 months postoperatively (PO) were assessed using a one-way ANOVA test to compare the three groups. Delta significance using one-way ANOVA was performed to assess anthropometric variable in the postoperative period (p < 0.05). RESULTS: 77 patients (24%) were included in Group 1 (G1), 101 (32%) in Group 2 (G2), and 141 (44%) in Group 3 (G3). The majority of patients, 71.7% in G1, 82.8% in G2, and 70% in G3, showed high triglycerides (TG) before surgery. A decrease in weight loss was observed in all groups followed by an increase in body weight in G2 and G3 at 36, 48 and 60 months. Laboratory results for G1, G2 and G3 showed no significant differences between groups at baseline and during the post-operative period. CONCLUSION: Our results suggest that weight regain after RYGB has no significant impact on the long-term evolution of the lipid profile and glycemia.

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Abstract Objective: Roux-en-Y gastric bypass (RYGB) reduces body weight and the comorbidities associated with obesity. The aim of this study was to evaluate whether glucose and lipid profiles were maintained during a 5-year follow-up period after RYGB. Subjects and methods: Anthropometric and laboratory data from 323 patients who had undergone this operation were analyzed. Differences in laboratory variables between the baseline and 12, 24, 36, 48 and 60 months postoperatively (PO) were assessed using a one-way ANOVA test to compare the three groups. Delta significance using one-way ANOVA was performed to assess anthropometric variable in the postoperative period (p < 0.05). Results: 77 patients (24%) were included in Group 1 (G1), 101 (32%) in Group 2 (G2), and 141 (44%) in Group 3 (G3). The majority of patients, 71.7% in G1, 82.8% in G2, and 70% in G3, showed high triglycerides (TG) before surgery. A decrease in weight loss was observed in all groups followed by an increase in body weight in G2 and G3 at 36, 48 and 60 months. Laboratory results for G1, G2 and G3 showed no significant differences between groups at baseline and during the post-operative period. Conclusion: Our results suggest that weight regain after RYGB has no significant impact on the long-term evolution of the lipid profile and glycemia.

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BACKGROUND: Studies on diabetic foot and its complications involving a significant and representative sample of patients in South American countries are scarce. The main objective of this study was to acquire clinical and epidemiological data on a large cohort of diabetic patients from 19 centers from Brazil and focus on factors that could be associated with the risk of ulcer and amputation. METHODS: This study presents cross sectional, baseline results of the BRAZUPA Study. A total of 1455 patients were included. Parameters recorded included age, gender, ethnicity, diabetes and comorbidity-related records, previous ulcer or amputation, clinical symptomatic score, foot classification and microvascular complications. RESULTS: Patients with ulcer had longer disease duration (17.2 ± 9.9 vs. 13.2 ± 9.4 years; p < 0.001), and poorer glycemic control (HbA1c 9.23 ± 2.03 vs. 8.35 ± 1.99; p < 0.001). Independent risk factors for ulcer were male gender (OR 1.71; 95 % CI 1.2-3.7), smoking (OR 1.78; 95 % CI 1.09-2.89), neuroischemic foot (OR 20.34; 95 % CI 9.31-44.38), region of origin (higher risk for those from developed regions, OR 2.39; 95 % CI 1.47-3.87), presence of retinopathy (OR 1.68; 95 % CI 1.08-2.62) and absence of vibratory sensation (OR 7.95; 95 % CI 4.65-13.59). Risk factors for amputation were male gender (OR 2.12; 95 % CI 1.2-3.73), type 2 diabetes (OR 3.33; 95 % CI 1.01-11.1), foot at risk classification (higher risk for ischemic foot, OR 19.63; 95 % CI 3.43-112.5), hypertension (lower risk, OR 0.3; 95 % CI 0.14-0.63), region of origin (South/Southeast, OR 2.2; 95 % CI 1.1-4.42), previous history of ulcer (OR 9.66; 95 % CI 4.67-19.98) and altered vibratory sensation (OR 3.46; 95 % CI 1.64-7.33). There was no association between either outcome and ethnicity. CONCLUSIONS: Ulcer and amputation rates were high. Age at presentation was low and patients with ulcer presented a higher prevalence of neuropathy compared to ischemic foot at risk. Ischemic disease was more associated with amputations. Ethnical differences were not of great importance in a miscegenated population.