Salivary immunoglobulin levels and periodontal indices in Brazilian children with and without type 1 diabetes.

This cross-sectional study evaluated the association between salivary immunoglobulins, plaque index, and gingival index in Brazilian children with and without type 1 diabetes mellitus (DM1). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for the reporting of observational studies was followed. The DM1 group had 38 children, and an equal number of volunteers matched by sex and age were recruited as controls. Clinical examination was performed for plaque index and gingival index determination. Non-stimulated whole saliva was collected. Concentrations of IgA, IgG, and IgM were determined by ELISA test. Data were tested by the Kolmogorov-Smirnov, Mann-Whitney, and Spearman tests and a multiple linear regression model (p<0.05) was performed. Gingival index was higher in the Control (DM1: 0.16±0.17; Control: 0.24±0.23, p=0.040). In DM1, there was a correlation between IgA and age (rho=0.371, p=0.024), IgM and IgG (rho=0.459, p=0.007), and IgM and gingival index (rho=0.394, p=0.014). In DM1, multiple linear regression showed that age (p=0.041; ß=0.363), gingival index (p=0.041; ß=0.398), and plaque index (p=0.008; ß=-0.506) were good predictors of IgA levels in saliva. Thus, IgA was the only researched immunoglobulin that was directly associated with plaque and gingival indices in Brazilian children with DM1, but not in control subjects.

Salivary immunoglobulin levels and periodontal indices in Brazilian children with and without type 1 diabetes

Abstract This cross-sectional study evaluated the association between salivary immunoglobulins, plaque index, and gingival index in Brazilian children with and without type 1 diabetes mellitus (DM1). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for the reporting of observational studies was followed. The DM1 group had 38 children, and an equal number of volunteers matched by sex and age were recruited as controls. Clinical examination was performed for plaque index and gingival index determination. Non-stimulated whole saliva was collected. Concentrations of IgA, IgG, and IgM were determined by ELISA test. Data were tested by the Kolmogorov-Smirnov, Mann-Whitney, and Spearman tests and a multiple linear regression model (p<0.05) was performed. Gingival index was higher in the Control (DM1: 0.16±0.17; Control: 0.24±0.23, p=0.040). In DM1, there was a correlation between IgA and age (rho=0.371, p=0.024), IgM and IgG (rho=0.459, p=0.007), and IgM and gingival index (rho=0.394, p=0.014). In DM1, multiple linear regression showed that age (p=0.041; β=0.363), gingival index (p=0.041; β=0.398), and plaque index (p=0.008; β=-0.506) were good predictors of IgA levels in saliva. Thus, IgA was the only researched immunoglobulin that was directly associated with plaque and gingival indices in Brazilian children with DM1, but not in control subjects.

Morningness/eveningness in gestational diabetes mellitus: clinical characteristics and maternal-neonatal outcomes

ABSTRACT Objective: This study aims to evaluate the impact of morning-evening preference in pregnancy outcomes in gestational diabetes mellitus (GDM). Materials and methods: This is a prospective cohort study of 2nd-3rd trimester GDM outpatient care in Fortaleza, Brazil (2018-2020). Eveningness was defined by the Horne-Östberg Morningness-Eveningness-Questionnaire (MEQ ≤ 41). Furthermore, we obtained a 7-day actigraphic register. Subjective sleep quality, daytime somnolence, insomnia, fatigue and depressive symptoms were also evaluated. Associations with pregnancy outcomes were investigated. Results: Among 305 patients with GDM, evening preference was found in 21 (6.9%). Patients with evening preference had worse sleep quality (p < 0.01), greater severity of insomnia (p < 0.005), fatigue (p < 0.005) and depressive symptoms (<0.009). Evening chronotype was associated with preeclampsia [p = 0.01; OR = 0.27; CI 0.09-0.79] and a greater need for admission to a neonatal intensive care unit (NICU) [p = 0.02; OR = 0.23; CI .0.06-0.80]. A lower MEQ score confirmed an association with preeclampsia [p = 0.002; OR = 0.94; CI 0.90-0.97] and this was maintained after controlling for age, arterial hypertension, sleep quality, fatigue and depressive symptoms [p < 005; OR = 0.91; CI 0.87-0.95]. Conclusion: In GDM, patients with evening preference had worse sleep quality, more insomnia, fatigue, and depressive symptoms. Furthermore, eveningness was independently associated with preeclampsia. These results indicate the important role of eveningness in adverse pregnancy outcomes.

Morningness/eveningness in gestational diabetes mellitus: clinical characteristics and maternal-neonatal outcomes.

Objective: This study aims to evaluate the impact of morning-evening preference in pregnancy outcomes in gestational diabetes mellitus (GDM). Methods: This is a prospective cohort study of 2nd-3rd trimester GDM outpatient care in Fortaleza, Brazil (2018-2020). Eveningness was defined by the Horne-Östberg Morningness-Eveningness-Questionnaire (MEQ ≤ 41). Furthermore, we obtained a 7-day actigraphic register. Subjective sleep quality, daytime somnolence, insomnia, fatigue and depressive symptoms were also evaluated. Associations with pregnancy outcomes were investigated. Results: Among 305 patients with GDM, evening preference was found in 21 (6.9%). Patients with evening preference had worse sleep quality (p < 0.01), greater severity of insomnia (p < 0.005), fatigue (p < 0.005) and depressive symptoms (<0.009). Evening chronotype was associated with preeclampsia [p = 0.01; OR = 0.27; CI 0.09-0.79] and a greater need for admission to a neonatal intensive care unit (NICU) [p = 0.02; OR = 0.23; CI .0.06-0.80]. A lower MEQ score confirmed an association with preeclampsia [p = 0.002; OR = 0.94; CI 0.90-0.97] and this was maintained after controlling for age, arterial hypertension, sleep quality, fatigue and depressive symptoms [p < 005; OR = 0.91; CI 0.87-0.95]. Conclusion: In GDM, patients with evening preference had worse sleep quality, more insomnia, fatigue, and depressive symptoms. Furthermore, eveningness was independently associated with preeclampsia. These results indicate the important role of eveningness in adverse pregnancy outcomes.

Hyperglycemia in pregnancy: sleep alterations, comorbidities and pharmacotherapy.

OBJECTIVE: To investigate sleep alterations and associated factors in pregnant diabetic women (n=141). METHODS: Sleep profile, sociodemographics and clinical information were collected. Poor sleep quality (Pittsburgh Sleep Quality Index >5) and excessive daytime sleepiness (Epworth Sleepiness Scale ≥10), sleep duration (h), sleep latency (min), frequent sleep interruption and short sleep (≤6 h) were assessed in type 1 diabetes mellitus (16.3%), type 2 diabetes mellitus (25.5%) and gestational diabetes mellitus (58.2%). RESULTS: Poor sleep quality was found in 58.8% of patients and daytime sleepiness in 25.7%, regardless of hyperglycemia etiology. No correlation existed between daytime sleepiness and poor sleep quality (Pearson correlation r=0.02, p=0.84). Short sleep duration occurred in 1/3 of patients (31.2%). Sleep interruptions due to frequent urination affected 72% of all and sleep interruptions due to any cause 71.2%. Metformin was used by 65.7% of type 2 diabetes mellitus and 28.7% of gestational diabetes mellitus. In gestational diabetes mellitus, parity number was independently associated with poor sleep quality (p=0.02; OR=1.90; 95%CI 1.07-3.36) and metformin use was also independently associated with poor sleep quality (p=0.03; OR=2.36; 95%CI 1.05-5.29). CONCLUSIONS: Our study originally shows that poor sleep quality and excessive daytime sleepiness are frequent in diabetic pregnancy due to different etiologies. Interestingly, only in gestational diabetes mellitus, metformin therapy and higher parity were associated with poor sleep quality.

Hyperglycemia in pregnancy: sleep alterations, comorbidities and pharmacotherapy

SUMMARY OBJECTIVE: To investigate sleep alterations and associated factors in pregnant diabetic women (n=141). METHODS: Sleep profile, sociodemographics and clinical information were collected. Poor sleep quality (Pittsburgh Sleep Quality Index >5) and excessive daytime sleepiness (Epworth Sleepiness Scale ≥10), sleep duration (h), sleep latency (min), frequent sleep interruption and short sleep (≤6 h) were assessed in type 1 diabetes mellitus (16.3%), type 2 diabetes mellitus (25.5%) and gestational diabetes mellitus (58.2%). RESULTS: Poor sleep quality was found in 58.8% of patients and daytime sleepiness in 25.7%, regardless of hyperglycemia etiology. No correlation existed between daytime sleepiness and poor sleep quality (Pearson correlation r=0.02, p=0.84). Short sleep duration occurred in 1/3 of patients (31.2%). Sleep interruptions due to frequent urination affected 72% of all and sleep interruptions due to any cause 71.2%. Metformin was used by 65.7% of type 2 diabetes mellitus and 28.7% of gestational diabetes mellitus. In gestational diabetes mellitus, parity number was independently associated with poor sleep quality (p=0.02; OR=1.90; 95%CI 1.07-3.36) and metformin use was also independently associated with poor sleep quality (p=0.03; OR=2.36; 95%CI 1.05-5.29). CONCLUSIONS: Our study originally shows that poor sleep quality and excessive daytime sleepiness are frequent in diabetic pregnancy due to different etiologies. Interestingly, only in gestational diabetes mellitus, metformin therapy and higher parity were associated with poor sleep quality.

Portuguese-Brazilian evidence-based guideline on the management of hyperglycemia in type 2 diabetes mellitus.

BACKGROUND: In current management of type 2 diabetes (T2DM), cardiovascular and renal prevention have become important targets to be achieved. In this context, a joint panel of four endocrinology societies from Brazil and Portugal was established to develop an evidence-based guideline for treatment of hyperglycemia in T2DM. METHODS: MEDLINE (via PubMed) was searched for randomized clinical trials, meta-analyses, and observational studies related to diabetes treatment. When there was insufficient high-quality evidence, expert opinion was sought. Updated positions on treatment of T2DM patients with heart failure (HF), atherosclerotic CV disease (ASCVD), chronic kidney disease (CKD), and patients with no vascular complications were developed. The degree of recommendation and the level of evidence were determined using predefined criteria. RESULTS AND CONCLUSIONS: In non-pregnant adults, the recommended HbA1c target is below 7%. Higher levels are recommended in frail older adults and patients at higher risk of hypoglycemia. Lifestyle modification is recommended at all phases of treatment. Metformin is the first choice when HbA1c is 6.5-7.5%. When HbA1c is 7.5-9.0%, dual therapy with metformin plus an SGLT2i and/or GLP-1RA (first-line antidiabetic agents, AD1) is recommended due to cardiovascular and renal benefits. If an AD1 is unaffordable, other antidiabetic drugs (AD) may be used. Triple or quadruple therapy should be considered when HbA1c remains above target. In patients with clinical or subclinical atherosclerosis, the combination of one AD1 plus metformin is the recommended first-line therapy to reduce cardiovascular events and improve blood glucose control. In stable heart failure with low ejection fraction (< 40%) and glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2, metformin plus an SGLT-2i is recommended to reduce cardiovascular mortality and heart failure hospitalizations and improve blood glucose control. In patients with diabetes-associated chronic kidney disease (CKD) (eGFR 30-60 mL/min/1.73 m2 or eGFR 30-90 mL/min/1.73 m2 with albuminuria > 30 mg/g), the combination of metformin and an SGLT2i is recommended to attenuate loss of renal function, reduce albuminuria and improve blood glucose control. In patients with severe renal failure, insulin-based therapy is recommended to improve blood glucose control. Alternatively, GLP-1RA, DPP4i, gliclazide MR and pioglitazone may be considered to reduce albuminuria. In conclusion, the current evidence supports individualizing anti-hyperglycemic treatment for T2DM.

Efficacy and safety of evogliptin in the treatment of type 2 diabetes mellitus in a Brazilian population: a randomized bridging study.

BACKGROUND: Evogliptin (EVO) is a potent and selective dipeptidyl peptidase-4 inhibitor (DPP4i) developed for the treatment of type 2 diabetes mellitus (T2DM). DPP4is are known to exhibit a better glucose-lowering effect in Asians compared to other ethnic groups. Once EVO's clinical development program was conducted in Asian patients, this bridging study was designed to validate for the Brazilian population the efficacy and safety of the approved dose regimen (once-daily 5.0 mg). METHODS: In this randomized, double-blind, double-dummy, parallel trial, 146 patients with T2DM with inadequate glycemic control on diet and exercise (7.5% ≤ HbA1c ≤ 10.5%) were randomly assigned to a 12-week once-daily treatment with EVO 2.5 mg (N = 35), EVO 5 mg (N = 36), EVO 10 mg (N = 36), or sitagliptin (SITA) 100 mg (N = 39). Absolute changes (Week 12-baseline) in HbA1c, fasting plasma glucose (FPG) and body weight (BW) were obtained. One-sided one sample t test was used to determine if mean HbA1c reduction in each group was < - 0.5% (beneficial metabolic response). An analysis of covariance estimated the change in HbA1c and FPG adjusted by baseline HbA1c, FPG, body mass index (BMI) and study site. Response rates to treatment were also established. No between-group statistical comparisons were planned. RESULTS: HbA1c mean reductions were - 1.26% (90% CI - 1.7%, - 0.8%), - 1.12% (90% CI - 1.4%, - 0.8%), - 1.29% (90% CI - 1.6%, - 1.0%), and - 1.15% (90% CI - 1.5%, - 0.8%) in groups EVO 2.5 mg, EVO 5 mg, EVO 10 mg, and SITA 100 mg, respectively. FPG levels showed a mean increase of 10.89 mg/dL in group EVO 2.5 mg, with significant mean reductions of - 18.94 mg/dL, - 21.17 mg/dL, and - 39.90 mg/dL in those treated with EVO 5 mg, EVO 10 mg, and SITA 100 mg, respectively. BW showed significant reductions of approximately 1 kg in patients treated with EVO 5 mg, EVO 10 mg, and SITA 100 mg. Mean adjusted reductions of HbA1c and FPG levels confirmed the significant clinical benefit of all study treatments. The clinical benefit of EVO's "target" dose (5 mg) was confirmed. No safety concerns were identified. CONCLUSIONS: These results validate for the Brazilian population the approved dose regimen of EVO (once-daily 5 mg).Trial registration ClinicalTrials.gov Identifier: NCT02689362 (first posted on 02/23/2016).

Adiponectin levels and sleep deprivation in patients with endocrine metabolic disorders.

BACKGROUND: Sleep abnormalities are frequent in patients with endocrine metabolic disorders (EMD) such as arterial hypertension, diabetes and obesity. Adiponectin is a peptide largely secreted by adipocytes and has various properties e.g. anti-inflammatory, antioxidant, antiatherogenic, pro-angiogenic, vasoprotective and insulin-sensitizing. Adiponectin inversely relates to body weight and when its concentration decreases, the resistin concentration increases resulting in greater insulin resistance. OBJECTIVE: The objective of this study is to examine factors influencing adiponectin levels in a population with EMD. METHODS: This was a cross-sectional evaluation of 332 patients (18 to 80y) presenting arterial hypertension, pre-diabetes, diabetes, and/or obesity. Investigation included clinical evaluation of comorbidities, general blood tests and adiponectin measures (ELISA). Chronic sleep deprivation was determined if habitual sleep was <6 hours >4 days/week. RESULTS: Arterial hypertension (78.5%), type-2 diabetes (82.3%), and overweight (45.0%)/obesity (38.8%) were frequent. Patients with type-2 diabetes tended to have more chronic sleep deprivation (p=0.05). Adiponectin levels increased with age and were inversely correlated with sagittal abdominal diameter (p=0.04) and fasting insulin (p=0.001). Chronic sleep deprivation was associated with higher adiponectin concentration [OR=1.34; CI=1.13-1.58; p<0.005] and this was maintained after adjustment for gender, age, body mass index, menopause, arterial hypertension, American Diabetes Association classification and physical exercise levels [OR=1.38; 0=1.14-1.66: p=0.001]. CONCLUSION: In patients with EMD, adiponectin is influenced not only by obesity but also by age and sleep deprivation. The latter finding may be explained by a compensatory effect or a counter regulation to minimize the harmful effects of sleep deprivation.

Adiponectin levels and sleep deprivation in patients with endocrine metabolic disorders

SUMMARY BACKGROUND: Sleep abnormalities are frequent in patients with endocrine metabolic disorders (EMD) such as arterial hypertension, diabetes and obesity. Adiponectin is a peptide largely secreted by adipocytes and has various properties e.g. anti-inflammatory, antioxidant, antiatherogenic, pro-angiogenic, vasoprotective and insulin-sensitizing. Adiponectin inversely relates to body weight and when its concentration decreases, the resistin concentration increases resulting in greater insulin resistance. OBJECTIVE: The objective of this study is to examine factors influencing adiponectin levels in a population with EMD. METHODS: This was a cross-sectional evaluation of 332 patients (18 to 80y) presenting arterial hypertension, pre-diabetes, diabetes, and/or obesity. Investigation included clinical evaluation of comorbidities, general blood tests and adiponectin measures (ELISA). Chronic sleep deprivation was determined if habitual sleep was <6 hours >4 days/week. RESULTS: Arterial hypertension (78.5%), type-2 diabetes (82.3%), and overweight (45.0%)/obesity (38.8%) were frequent. Patients with type-2 diabetes tended to have more chronic sleep deprivation (p=0.05). Adiponectin levels increased with age and were inversely correlated with sagittal abdominal diameter (p=0.04) and fasting insulin (p=0.001). Chronic sleep deprivation was associated with higher adiponectin concentration [OR=1.34; CI=1.13-1.58; p<0.005] and this was maintained after adjustment for gender, age, body mass index, menopause, arterial hypertension, American Diabetes Association classification and physical exercise levels [OR=1.38; 0=1.14-1.66: p=0.001]. CONCLUSION: In patients with EMD, adiponectin is influenced not only by obesity but also by age and sleep deprivation. The latter finding may be explained by a compensatory effect or a counter regulation to minimize the harmful effects of sleep deprivation.

RESUMO INTRODUÇÃO: Problemas de sono são frequentes em pacientes com distúrbios endócrino-metabólicos (DEM), como hipertensão arterial, diabetes e obesidade. A adiponectina é um peptídeo segregado por adipócitos e apresenta diversas propriedades, como por exemplo, anti-inflamatória, antioxidante, antiaterogênica, pró-angiogênica e vasoprotetora. A adiponectina relaciona-se inversamente com o peso corporal. OBJETIVO: Examinar os fatores que influenciam os níveis de adiponectina em uma população com DEM. MÉTODOS: Trata-se de uma avaliação transversal com 332 pacientes (18 a 80 anos) apresentando hipertensão arterial, pré-diabetes, diabetes e/ou obesidade. A investigação incluiu avaliação clínica de comorbidades, exames de sangue e medidas de adiponectina (Elisa). A restrição crônica do sono foi determinada com o sono habitual <6 horas >4 dias/semana. RESULTADOS: Doenças como hipertensão arterial (78,5%), diabetes tipo 2 (82,3%) e sobrepeso (45,0%)/obesidade (38,8%) foram frequentes. Pacientes com diabetes tipo 2 apresentaram uma tendência na restrição crônica do sono (p=0,05). Os níveis de adiponectina aumentaram com a idade e foram inversamente correlacionados com o diâmetro abdominal sagital (p=0,04) e com a insulina em jejum (p=0,001). A restrição crônica do sono foi associada à maior concentração de adiponectina [OR=1,34; CI=1,13-1,58; p<0,005] e isso foi mantido após ajuste por gênero, idade, índice de massa corporal, menopausa, hipertensão arterial, classificação dos níveis da American Diabetes Association e exercício físico [OR=1,38; CI=1,14-1,66: p=0,001]. CONCLUSÕES: Em pacientes com DEM, a adiponectina é influenciada não apenas pela obesidade, mas também pela idade e pela restrição de sono. O último achado pode ser explicado por um efeito compensatório ou por um regulamento contrário para minimizar os efeitos nocivos da restrição do sono.

Health-related quality of life and utility values associated to hypoglycemia in patients with type 1 diabetes mellitus treated in the Brazilian Public Health System: a multicenter study.

BACKGROUND: Hypoglycemia is a critical and limiting factor of a good metabolic control and can adversely affect the quality of life of diabetic patients. The aim of the study was to evaluate the health-related quality of life and calculate utilities values associated with hypoglycemia in patients with type 1 diabetes mellitus (T1DM). METHODS: A multicenter, cross-sectional and observational study with T1DM patients from reference centers of the Brazilian public health system was conducted in three cities. Demographic and clinical data were collected, besides details on the frequency and severity of hypoglycemia. Health-related quality of life was assessed using EQ-5D instrument and utility values generated. RESULTS: 221 patients (107 women, 114 men), aged 29.8 ± 11.6 and disease duration of 14.2 ± 9.1 years were included. Most patients (n = 214, 96.8%) reported at least one symptomatic hypoglycemia in the last three months, 68% (n = 150) reported nocturnal episodes and 34.8% (n = 77) reported severe episodes. High frequency (daily or weekly) was observed in 38.6 and 26% of those reporting nocturnal or severe hypoglycemia, respectively. The median visual analog scale was 70 [60-85] for all patients, with differences between those with and without severe hypoglycemia (70 [60-80] vs 80 [61-90]; p = 0.006) and those with high and low frequency (62.5 [50-72.25] vs 70 [60-80]; p = 0.007). The median utility values was 0.801 [0.756-1.000] for all patients, with difference between those with high and low frequency of severe episodes (0.737 [0.628-1.000] vs 0.801 [0.756-1.000]; p = 0.02). CONCLUSIONS: This study shows the high frequency of hypoglycemia in a sample of T1DM patients treated in three reference centers of the Brazilian public health system and the impact of severe episodes on health-related quality of life. Utility values were generated and can be used in economic analysis for treatments that could decrease hypoglycemia and consequently improve quality of life.

The HOMA-Adiponectin (HOMA-AD) Closely Mirrors the HOMA-IR Index in the Screening of Insulin Resistance in the Brazilian Metabolic Syndrome Study (BRAMS).

BACKGROUND: The major adverse consequences of obesity are associated with the development of insulin resistance (IR) and adiposopathy. The Homeostasis Model Assessment-Adiponectin (HOMA-AD) was proposed as a modified version of the HOMA1-IR, which incorporates adiponectin in the denominator of the index. OBJECTIVES: To evaluate the performance of the HOMA-AD index compared with the HOMA1-IR index as a surrogate marker of IR in women, and to establish the cutoff value of the HOMA-AD. SUBJECTS/METHODS: The Brazilian Metabolic Syndrome Study (BRAMS) is a cross-sectional multicenter survey. The data from 1,061 subjects met the desired criteria: 18-65 years old, BMI: 18.5-49.9 Kg/m² and without diabetes. The IR was assessed by the indexes HOMA1-IR and HOMA-AD (total sample) and by the hyperglycemic clamp (n = 49). Metabolic syndrome was defined using the IDF criteria. RESULTS: For the IR assessed by the clamp, the HOMA-AD demonstrated a stronger coefficient of correlation (r = -0.64) compared with the HOMA1-IR (r = -0.56); p < 0.0001. In the ROC analysis, compared with the HOMA1-IR, the HOMA-AD showed higher values of the AUC for the identification of IR based on the clamp test (AUC: 0.844 vs. AUC: 0.804) and on the metabolic syndrome (AUC: 0.703 vs. AUC: 0.689), respectively; p < 0.001 for all. However, the pairwise comparison did not show evidence of superiority for the HOMA-AD in comparison with the HOMA1-IR in the diagnosis of IR and metabolic syndrome (p > 0.05). The optimal cutoff identified for the HOMA-AD for the diagnosis of IR was 0.95. CONCLUSIONS: The HOMA-AD index was demonstrated to be a useful surrogate marker for detecting IR among adult women and presented a similar performance compared with the HOMA1-IR index. These results may assist physicians and researchers in determining which method to use to evaluate IR in light of the available facilities.

Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregnancy complicated by GDM in delaying or preventing the development of type 2 diabetes. METHODS: Women aged 18 or older identified as having recent GDM are recruited and followed by telephone to assess eligibility for the trial. To be eligible, women must have used insulin during pregnancy or present intermediate hyperglycemia postpartum. Women are encouraged to enter the trial as early as 10 weeks, and are permitted to do so up to 2 years after a pregnancy with GDM. An estimated 740 women will be randomized to either conventional care or to coach-based interventions focused on breastfeeding, weight loss, healthy eating, and increased physical activity, and predominantly delivered by telephone. Women are followed annually to detect new onset diabetes, the primary outcome, and additional secondary outcomes which include reversion to normoglycemia, weight loss, physical activity and fitness, and insulin resistance. DISCUSSION: Though previous studies have demonstrated that type 2 diabetes can be delayed or prevented, no study has yet demonstrated the feasibility and effectiveness of similar interventions implemented in the postpartum period for women with recent GDM. If shown to be successful, this approach could become an important means of preventing diabetes in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02327286; Registered 23 December 2014.

Baseline characteristics and risk factors for ulcer, amputation and severe neuropathy in diabetic foot at risk: the BRAZUPA study.

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.

Sagittal Abdominal Diameter as a Surrogate Marker of Insulin Resistance in an Admixtured Population--Brazilian Metabolic Syndrome Study (BRAMS).

BACKGROUND: Sagittal abdominal diameter (SAD) has been proposed as a surrogate marker of insulin resistance (IR). However, the utilization of SAD requires specific validation for each ethnicity. We aimed to investigate the potential use of SAD, compared with classical anthropometrical parameters, as a surrogate marker of IR and to establish the cutoff values of SAD for screening for IR. METHODS: A multicenter population survey on metabolic disorders was conducted. A race-admixtured sample of 824 adult women was assessed. The anthropometric parameters included: BMI, waist circumference (WC), waist-to-hip ratio and SAD. IR was determined by a hyperglycemic clamp and the HOMA-IR index. RESULTS: After adjustments for age and total body fat mass, SAD (r = 0.23 and r = -0.70) and BMI (r = 0.20 and r = -0.71) were strongly correlated with the IR measured by the HOMA-IR index and the clamp, respectively (p < 0.001). In the ROC analysis, the optimal cutoff for SAD in women was 21.0 cm. The women with an increased SAD presented 3.2 (CI 95%: 2.1-5.0) more likelihood of having IR, assessed by the HOMA-IR index compared with those with normal SAD (p < 0.001); whereas women with elevated BMI and WC were 2.1 (95% CI: 1.4-3.3) and 2.8 (95% CI: 1.7-4.5) more likely to have IR (p < 0.001), respectively. No statistically significant results were found for waist-to-hip ratio. CONCLUSIONS: SAD can be a suitable surrogate marker of IR. Understanding and applying routine and simplified methods is essential because IR is associated with an increased risk of obesity-related diseases even in the presence of normal weight, slight overweight, as well as in obesity. Further prospective analysis will need to verify SAD as a determinant of clinical outcomes, such as type 2 diabetes and cardiovascular events, in the Brazilian population.

Relevance of Target-Organ Lesions as Predictors of Mortality in Patients with Diabetes Mellitus / Relevância de Lesões em Órgãos-Alvo como Preditores de Mortalidade em Pacientes com Diabetes

Background: Patients with diabetes are in extract higher risk for fatal cardiovascular events. Objective: To evaluate major predictors of mortality in subjects with type 2 diabetes. Methods: A cohort of 323 individuals with type 2 diabetes from several regions of Brazil was followed for a long period. Baseline electrocardiograms, clinical and laboratory data obtained were used to determine hazard ratios (HR) and confidence interval (CI) related to cardiovascular and total mortality. Results: After 9.2 years of follow-up (median), 33 subjects died (17 from cardiovascular causes). Cardiovascular mortality was associated with male gender; smoking; prior myocardial infarction; long QTc interval; left ventricular hypertrophy; and eGFR <60 mL/min. These factors, in addition to obesity, were predictors of total mortality. Cardiovascular mortality was adjusted for age and gender, but remained associated with: smoking (HR = 3.8; 95% CI 1.3-11.8; p = 0.019); prior myocardial infarction (HR = 8.5; 95% CI 1.8-39.9; p = 0.007); eGFR < 60 mL/min (HR = 9.5; 95% CI 2.7-33.7; p = 0.001); long QTc interval (HR = 5.1; 95% CI 1.7-15.2; p = 0.004); and left ventricular hypertrophy (HR = 3.5; 95% CI 1.3-9.7; p = 0.002). Total mortality was associated with obesity (HR = 2.3; 95% CI 1.1-5.1; p = 0.030); smoking (HR = 2.5; 95% CI 1.0-6.1; p = 0.046); prior myocardial infarction (HR = 3.1; 95% CI 1.4-6.1; p = 0.005), and long QTc interval (HR = 3.1; 95% CI 1.4-6.1; p = 0.017). Conclusions: Biomarkers of simple measurement, particularly those related to target-organ lesions, were predictors of mortality in subjects with type 2 diabetes. .

Fundamento: Pacientes com diabetes apresentam-se em extrato de maior risco para eventos cardiovasculares fatais. Objetivo: Avaliar os principais preditores associados às taxas de mortalidade em pacientes com diabetes tipo 2. Métodos: Estudo de coorte composto por 323 indivíduos com diabetes mellitus do tipo 2, de várias regiões do Brasil, acompanhados em longo prazo. Dados clínicos, laboratoriais e eletrocardiográficos foram obtidos no período basal e aplicados no modelo Cox de regressão, para examinar a associação dessas variáveis com as taxas de mortalidade e determinação de hazard ratio (HR) e intervalo de confiança (IC). Resultados: Após 9,2 anos (mediana) de seguimento, 33 pacientes morreram (sendo 17 por causas cardiovasculares). A mortalidade cardiovascular foi associada a gênero masculino, tabagismo, infarto do miocárdio prévio, intervalo QTc longo, hipertrofia ventricular esquerda e taxa de filtração glomerular (TFG) <60 mL/min. Esses biomarcadores, além da obesidade, também foram preditores para mortalidade total. Após ajustes para idade e gênero, a mortalidade cardiovascular, manteve-se associada a tabagismo (HR = 3,8; IC 95% 1,3-11,8; p = 0,019), infarto prévio do miocárdio (HR = 8,5; IC 95% 1,8-39,9; p = 0,007), TFG < 60 mL/min (HR = 9,5; IC 95% 2,7-33,7; p = 0,001), intervalo QTc longo (HR = 5,1; IC 95% 1,7-15,2; p = 0,004), hipertrofia ventricular esquerda (HR = 3,5; IC 95% 1,3-9,7; p = 0,002). A mortalidade total foi associada com obesidade (HR = 2,3; IC 95% 1,1-5,1; p = 0,030), tabagismo (HR = 2,5; IC 95% 1,0-6,1; p = 0,046), infarto prévio do miocárdio (HR = 3,1; 95% CI 1,4-6,1; p = 0,005) e intervalo QTc longo (HR = 3,1; 95% CI 1,4-6,1; p = 0,017). Conclusões: Biomarcadores de simples mensuração, particularmente os que traduzem lesões de ...

Relevance of target-organ lesions as predictors of mortality in patients with diabetes mellitus.

BACKGROUND: Patients with diabetes are in extract higher risk for fatal cardiovascular events. OBJECTIVE: To evaluate major predictors of mortality in subjects with type 2 diabetes. METHODS: A cohort of 323 individuals with type 2 diabetes from several regions of Brazil was followed for a long period. Baseline electrocardiograms, clinical and laboratory data obtained were used to determine hazard ratios (HR) and confidence interval (CI) related to cardiovascular and total mortality. RESULTS: After 9.2 years of follow-up (median), 33 subjects died (17 from cardiovascular causes). Cardiovascular mortality was associated with male gender; smoking; prior myocardial infarction; long QTc interval; left ventricular hypertrophy; and eGFR <60 mL/min. These factors, in addition to obesity, were predictors of total mortality. Cardiovascular mortality was adjusted for age and gender, but remained associated with: smoking (HR = 3.8; 95% CI 1.3-11.8; p = 0.019); prior myocardial infarction (HR = 8.5; 95% CI 1.8-39.9; p = 0.007); eGFR < 60 mL/min (HR = 9.5; 95% CI 2.7-33.7; p = 0.001); long QTc interval (HR = 5.1; 95% CI 1.7-15.2; p = 0.004); and left ventricular hypertrophy (HR = 3.5; 95% CI 1.3-9.7; p = 0.002). Total mortality was associated with obesity (HR = 2.3; 95% CI 1.1-5.1; p = 0.030); smoking (HR = 2.5; 95% CI 1.0-6.1; p = 0.046); prior myocardial infarction (HR = 3.1; 95% CI 1.4-6.1; p = 0.005), and long QTc interval (HR = 3.1; 95% CI 1.4-6.1; p = 0.017). CONCLUSIONS: Biomarkers of simple measurement, particularly those related to target-organ lesions, were predictors of mortality in subjects with type 2 diabetes.

Relevância de lesões em orgãos-alvo como preditores de mortalidade em pacientes com diabetes / Relevance of target-organ lesions as predictors of mortality in patients with diabetes mellitus

Fundamento: Pacientes com diabetes apresentam-se em extrato de maior risco para eventos cardiovasculares fatais.Objetivo: Avaliar os principais preditores associados às taxas de mortalidade em pacientes com diabetes tipo 2.Métodos: Estudo de coorte composto por 323 indivíduos com diabetes mellitus do tipo 2, de várias regiões do Brasil,acompanhados em longo prazo. Dados clínicos, laboratoriais e eletrocardiográficos foram obtidos no período basale aplicados no modelo Cox de regressão, para examinar a associação dessas variáveis com as taxas de mortalidade edeterminação de hazard ratio (HR) e intervalo de confiança (IC).Resultados: Após 9,2 anos (mediana) de seguimento, 33 pacientes morreram (sendo 17 por causas cardiovasculares).A mortalidade cardiovascular foi associada a gênero masculino, tabagismo, infarto do miocárdio prévio, intervaloQTc longo, hipertrofia ventricular esquerda e taxa de filtração glomerular (TFG) <60 mL/min. Esses biomarcadores,além da obesidade, também foram preditores para mortalidade total. Após ajustes para idade e gênero, a mortalidadecardiovascular, manteve-se associada a tabagismo (HR = 3,8; IC 95% 1,3-11,8; p = 0,019), infarto prévio do miocárdio(HR = 8,5; IC 95% 1,8-39,9; p = 0,007), TFG < 60 mL/min (HR = 9,5; IC 95% 2,7-33,7; p = 0,001), intervalo QTclongo (HR = 5,1; IC 95% 1,7-15,2; p = 0,004), hipertrofia ventricular esquerda (HR = 3,5; IC 95% 1,3-9,7; p = 0,002).A mortalidade total foi associada com obesidade (HR = 2,3; IC 95% 1,1-5,1; p = 0,030), tabagismo (HR = 2,5;IC 95% 1,0-6,1; p = 0,046), infarto prévio do miocárdio (HR = 3,1; 95% CI 1,4-6,1; p = 0,005) e intervalo QTc longo(HR = 3,1; 95% CI 1,4-6,1; p = 0,017).Conclusões: Biomarcadores de simples mensuração, particularmente os que traduzem lesões de órgãos-alvo, forampreditores de mortalidade em pacientes com diabetes tipo 2.