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AIMS: To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana). MATERIALS AND METHODS: In a single-centre, randomized, double-blinded phase 1 crossover study, we used the manual euglycaemic clamp technique to compare PK and PD profiles between single subcutaneous doses (0.3 units/kg) of the two regular insulins in participants with type 1 diabetes (T1DM) with a washout period of 14 (± 7) days between tests. RESULTS: We evaluated 56 participants. The mean participant age and body mass index were 32.9 years and 22.9 kg/m2 , respectively. The ratios (experimental/reference) of the geometric means of maximum plasma insulin concentration and for plasma insulin area under the curve (AUC) were 0.909 (90% confidence interval [CI] 0.822-1.01) and 0.993 (90% CI 0.944-1.04), respectively. The ratios of the geometric means of maximum glucose infusion rate (GIR) and for GIR AUC were 0.999 (95% CI 0.912-1.09) and 1.04 (95% CI 0.962-1.12), respectively. CONCLUSIONS: The experimental product regular human insulin and comparator Humulin® R are bioequivalent in patients with T1DM. Wider entry to the pharmaceutical market of affordable, biosimilar regular insulins may substantially improve access to insulin for many socioeconomically disadvantaged patients with diabetes.
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Medicamentos Biossimilares , Diabetes Mellitus Tipo 1 , Medicamentos Biossimilares/efeitos adversos , Estudos Cross-Over , Diabetes Mellitus Tipo 1/tratamento farmacológico , Método Duplo-Cego , Glucose/uso terapêutico , Técnica Clamp de Glucose , Humanos , Hipoglicemiantes , Insulina , Insulina Isófana/uso terapêutico , Insulina Regular Humana/uso terapêutico , Equivalência TerapêuticaRESUMO
BACKGROUND: There is a paucity of global data on cardiovascular disease (CVD) prevalence in people with type 2 diabetes (T2D). The primary objective of the CAPTURE study was to estimate the prevalence of established CVD and its management in adults with T2D across 13 countries from five continents. Additional objectives were to further characterize the study sample regarding demographics, clinical parameters and medication usage, with particular reference to blood glucose-lowering agents (GLAs: glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors) with demonstrated cardiovascular benefit in randomized intervention trials. METHODS: Data were collected from adults with T2D managed in primary or specialist care in Australia, China, Japan, Czech Republic, France, Hungary, Italy, Argentina, Brazil, Mexico, Israel, Kingdom of Saudi Arabia, and Turkey in 2019, using standardized methodology. CVD prevalence, weighted by diabetes prevalence in each country, was estimated for the overall CAPTURE sample and participating countries. Country-specific odds ratios for CVD prevalence were further adjusted for relevant demographic and clinical parameters. RESULTS: The overall CAPTURE sample included 9823 adults with T2D (n = 4502 from primary care; n = 5321 from specialist care). The overall CAPTURE sample had median (interquartile range) diabetes duration 10.7 years (5.6-17.9 years) and glycated hemoglobin 7.3% (6.6-8.4%) [56 mmol/mol (49-68 mmol/mol)]. Overall weighted CVD and atherosclerotic CVD prevalence estimates were 34.8% (95% confidence interval [CI] 32.7-36.8) and 31.8% (95% CI 29.7-33.8%), respectively. Age, gender, and clinical parameters accounted for some of the between-country variation in CVD prevalence. GLAs with demonstrated cardiovascular benefit were used by 21.9% of participants, which was similar in participants with and without CVD: 21.5% and 22.2%, respectively. CONCLUSIONS: In 2019, approximately one in three adults with T2D in CAPTURE had diagnosed CVD. The low use of GLAs with demonstrated cardiovascular benefit even in participants with established CVD suggested that most were not managed according to contemporary diabetes and cardiology guidelines. Study registration NCT03786406 (registered on December 20, 2018), NCT03811288 (registered on January 18, 2019).
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Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Fatores de Proteção , Medição de Risco , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: It is important to understand the most diverse cultural aspects related to religiosity. Scientifically, it is important to understand religious manifestations and their relation to health, and to differentiate them from psychopathological manifestations. OBJECTIVE: To evaluate the mental health of a group of mediums and compare it with that of a control group from the same religious context who do not manifest mediumship, using the Dissociative Disorders Interview Schedule (DDIS). METHODS: This was a cross-sectional study, evaluating 47 mediums (Group 1) and comparing them with 22 non-medium volunteers from the same religious context (Group 2) using the DDIS questionnaire. All results were matched with historical data from patients with dissociative identity disorder (DID) who answered the DDIS. RESULTS: Scores obtained from the DDIS were similar in both groups. The number of positive symptoms was comparable in a wide range of analyzed areas, involving but not being restricted to somatization disorder, major depressive episode, borderline personality disorder, extrasensory/paranormal experiences, physical/sexual abuse and five dissociative disorders. There were considerable differences when we compared these results with historical data from patients with DID. CONCLUSION: In agreement with the extant literature, these results showed that mediumship can be considered a non-pathological form of dissociative phenomena.
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Transtornos Dissociativos/diagnóstico , Entrevista Psicológica , Religião e Psicologia , Espiritualismo/psicologia , Adulto , Sobreviventes Adultos de Maus-Tratos Infantis/psicologia , Transtorno da Personalidade Borderline/diagnóstico , Brasil , Estudos Transversais , Transtorno Depressivo Maior/diagnóstico , Diagnóstico Diferencial , Feminino , Humanos , Acontecimentos que Mudam a Vida , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Substâncias/diagnósticoRESUMO
Background: Although aging is a process associated with the development of obesity, metabolic syndrome (MetS), and sarcopenia, the prevalence of these conditions in older adults from São Paulo, Brazil, is unclear. Methods: Therefore, the current study aimed to investigate the prevalence of obesity, sarcopenia, and MetS, both separately and together, in a community-based sample of older adults from São Paulo, Brazil. Data from the medical records of 418 older adults of both genders, aged 60 years or older (mean age 69.3 ± 6.5 years), who were not physically active, were used to conduct this retrospective cross-sectional study. Anthropometric variables were used to determine both body mass index (BMI) and Conicity index (C index). Sarcopenia and MetS were defined according to the criteria of the European Working Group on Sarcopenia in Older People and by the Brazilian Society of Endocrinology and Metabolism, respectively. Results: Based on BMI, the group of older men (n = 91) showed a predominance of adequate weight (n = 49) and the group of older women (n = 327) showed a predominance of obesity (n = 181). In association with obesity, while only the group of older women presented with sarcopenia (n = 5), 52 older women and 9 older men presented with MetS, and two older women presented with sarcopenia + MetS [prevalence ratio = 0.0385, 95% CI (0.007;0.1924)]. Based on the C index, 58 older women and 11 older men presented with MetS, while the occurrence of sarcopenia or MetS + sarcopenia was found in 32 and 5 older women, respectively [prevalence ratio = 0.0910, 95% CI (0.037;0.2241)]. Discussion: Our results suggest that obesity, as measured by BMI or the C Index, was more closely associated with the occurrence of MetS than sarcopenia, regardless of gender, and also that sarcopenic obesity was only found in the group of older women. Additionally, the prevalence ratio of obesity, sarcopenia, and MetS evidenced using the C index was 2.3 times higher than the values found using the BMI classification.
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BACKGROUND: Obesity remains a public health problem worldwide. The high prevalence of this condition in the population raises further concerns, considering that comorbidities are often associated with obesity. Among the comorbidities closely associated with obesity, metabolic syndrome (MS) is particularly important, which potentially increases the risk of manifestation of other disorders, such as the prothrombotic and systemic pro-inflammatory states. METHODS: A randomized, controlled clinical trial was performed involving female patients (n = 32) aged between 18 and 65 years, with a clinical diagnosis of MS, with severe obesity undergoing Roux-en-Y gastric bypass (RYGB). The study design followed the Consolidated Standards of Reporting Trials statement (CONSORT). Lipid profile, blood glucose and adipokines (adiponectin, leptin, and resistin) and (cytokines IL-1ß, IL-6, IL-17, IL-23, and TNF-α) in blood plasma samples were evaluated before and six months after RYGB. RESULTS: Patients undergoing RYGB (BSG) showed a significant improvement from preoperative grade III obesity to postoperative grade I obesity. The results showed that while HDL levels increased, the other parameters showed a significant reduction in their postoperative values when compared not only to the values observed before surgery in the BSG group, but also to the values obtained in the control group (CG). As for systemic inflammatory markers adiponectin, leptin, resistin, IL-1ß, IL-6, IL-17, IL-23 and TNF- α it was observed that the levels of resistin and IL-17 in the second evaluation increased significantly when compared to the levels observed in the first evaluation in the CG. In the BSG group, while the levels of adiponectin increased, the levels of the other markers showed significant reductions in the postoperative period, in relation to the respective preoperative levels. The analysis of Spearman's correlation coefficient showed a significant positive correlation between IL-17 and IL-23 in the preoperative period, significant positive correlations between TNF-α and IL-6, TNF-α and IL-17, IL-6 and IL-17, and IL-17 and IL-23 were observed postoperatively. CONCLUSIONS: According to our results, the reduction of anthropometric measurements induced by RYGB, significantly improves not only the plasma biochemical parameters (lipid profile and glycemia), but also the systemic inflammatory status of severely obese patients with MS. Trials registration NCT02409160.
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Obesity is a troubling public health problem as it increases risks of sleep disorders, respiratory complications, systemic arterial hypertension, cardiovascular diseases, type 2 diabetes mellitus, and metabolic syndrome (MetS). As a measure to counteract comorbidities associated with severe obesity, bariatric surgery stands out. This study aimed to investigate the adiponectin/leptin ratio in women with severe obesity with and without MetS who had undergone Roux-en-Y gastric bypass (RYGB) and to characterize the biochemical, glucose, and inflammatory parameters of blood in women with severe obesity before and after RYGB. Were enrolled females with severe obesity undergoing RYGP with MetS (n = 11) and without (n = 39). Anthropometric data and circulating levels of glucose, total cholesterol, high-density lipoprotein (HDL), non-HDL total cholesterol, low-density lipoprotein (LDL), adiponectin, and leptin were assessed before and 6 months after RYGB. Significant reductions in weight, body mass index, and glucose, total cholesterol, LDL, and leptin were observed after surgery, with higher levels of HDL, adiponectin, and adiponectin/leptin ratio being observed after surgery compared to the preoperative values of those. This study demonstrated that weight loss induced by RYGB in patients with severe obesity with or without MetS improved biochemical and systemic inflammatory parameters, particularly the adiponectin/leptin ratio.
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Diabetes Mellitus Tipo 2 , Derivação Gástrica , Síndrome Metabólica , Obesidade Mórbida , Humanos , Feminino , Leptina , Síndrome Metabólica/complicações , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Adiponectina , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/cirurgia , Diabetes Mellitus Tipo 2/metabolismo , Obesidade/complicações , Colesterol , GlucoseRESUMO
BACKGROUND: Type 2 diabetes (T2D) is a known risk factor for cardiovascular disease (CVD), and CVD is a major cause of mortality in patients with T2D. The CAPTURE study investigated the contemporary (2019) prevalence of established CVD in adults with T2D around the world. We report the findings from Brazil. METHODS: The multinational, non-interventional, cross-sectional CAPTURE study was conducted across 13 countries from five continents. The current manuscript explores data for the CAPTURE study sample in Brazil. Standardized demographic and clinical data were collected from adults with T2D aged ≥ 18 years attending a single routine healthcare visit in primary or specialized care between December 2018 and September 2019. Data were analyzed descriptively. RESULTS: Data from 912 adults with T2D were collected in the CAPTURE study in Brazil, with 822 patients from primary care and 90 patients from specialized care. Median (interquartile range [IQR]) patient characteristics were as follows: age 64 years (57; 71), diabetes duration 11 years (6; 19), glycated hemoglobin 7.7% (6.7; 9.1), and body mass index 29.5 kg/m2 (26.4; 33.5); 59% were female. The CVD prevalence and atherosclerotic CVD prevalence in the Brazil sample were 43.9% (95% confidence interval [CI] 40.9; 46.8) and 37.6% (95% CI 34.7; 40.5), respectively. The majority of patients with CVD had atherosclerotic CVD (85.8%). For the specific CVD subtypes, coronary heart disease prevalence was 27.9% (95% CI 25.2; 30.5), heart failure was 12.4% (95% CI 10.4; 14.4), cerebrovascular disease was 8.7% (95% CI 6.8; 10.5), and carotid artery disease was 3.4% (95% CI 2.3; 4.5). Glucagon-like peptide-1 receptor agonists and/or sodium-glucose co-transporter-2 inhibitors with proven cardiovascular benefit were prescribed to 15.5% of patients with CVD, compared with 18.4% of patients without CVD. CONCLUSIONS: CAPTURE was the first multinational, standardized study to provide contemporary data on CVD prevalence in adults with T2D in Brazil, and it demonstrated that almost one in two adults with T2D had established CVD. Except for carotid artery disease, the prevalence of all CVD subtypes in adults with T2D in Brazil appeared higher than the global CAPTURE prevalence. Trial registration NCT03786406, NCT03811288.
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BACKGROUND: The objective of this study was to evaluate the early results of the laparoscopic interposition of a segment of ileum associated with a sleeve gastrectomy (LII-SG) in order to treat patients with type 2 diabetes mellitus (T2DM) and BMI <35. Data regarding morbidly obese diabetic patients subjected to surgery has consistently been validated. To date, there is scarce information about morbidity and mortality related to the surgical treatment of a "true" typical diabetic population with BMI <35. METHODS: The procedures were performed in 454 patients (322 male, 132 female). Mean age was 53.6 ± 8 years (range = 27-75). Mean BMI was 29.7 ± 3.6 kg/m(2) (range = 19-34.8). All patients had the diagnosis of T2DM for at least 3 years. Insulin therapy was used by 45.6% of patients. Mean duration of T2DM was 10.8 ± 5.9 years (range = 3-35). Mean hemoglobin A(1c) was 8.8 ± 1.9%. Dyslipidemia was observed in 78.4%, hypertension in 64.8%, nephropathy in 28.6%, retinopathy in 32.6%, neuropathy in 34.6%, and coronary heart disease in 13%. RESULTS: There was no conversion to open surgery. All patients were evaluated postoperatively. Mortality was 0.4%. There were 29 major complications (6.4%) in 22 patients (4.8%) and 51 minor complications (11.2%). Reoperations were performed on 8 patients (1.7%). Twenty patients (4.4%) were readmitted to the hospital. Mean postoperative BMI was 25.8 ± 3.5 kg/m(2). Mean fasting plasma glucose decreased from 198 ± 69 to 128 ± 67 mg/dl and mean postprandial plasma glucose decreased from 262 ± 101 to 136 ± 43 mg/dl. CONCLUSIONS: The laparoscopic ileal interposition associated with a sleeve gastrectomy was considered a safe operation with low rates of morbidity and mortality in a diabetic population with BMI < 35. An early control of postprandial glycemia was observed.
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Diabetes Mellitus Tipo 2/cirurgia , Gastrectomia/métodos , Laparoscopia/métodos , Obesidade Mórbida/cirurgia , Adulto , Idoso , Análise de Variância , Índice de Massa Corporal , Brasil/epidemiologia , Distribuição de Qui-Quadrado , Diabetes Mellitus Tipo 2/complicações , Feminino , Gastrectomia/mortalidade , Humanos , Íleo/cirurgia , Laparoscopia/mortalidade , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/complicações , Complicações Pós-Operatórias/mortalidade , Reoperação , Resultado do TratamentoRESUMO
BACKGROUND: Laparoscopic ileal interposition associated with a sleeve gastrectomy (LII-SG) is a safe and effective operation for the treatment of type 2 diabetic (T2DM) patients with BMI below 35. The aim of this study was to evaluate insulin sensitivity (IS) and ß-cell function using the euglycemic hyperinsulinemic clamp (EHC) with the intravenous glucose tolerance test (IVGTT). METHODS: This was a prospective study of 24 T2DM patients submitted to a 3-hour EHC-IVGTT before and 1 month after LII-SG. Mean BMI was 29.0, mean age was 54.8 years and mean duration of T2DM was 10.2 years; insulin therapy was used by 62.5% of the patients. RESULTS: Mean BMI decreased from 29.0 to 25.8 (p < 0.001). Mean fasting plasma glucose and mean postprandial glucose were 202 and 251.3 mg/dl and dropped to 127.7 and 131.8 mg/dl (p < 0.001), respectively. Mean preoperative IS was 1.4 mmol·min(-1)·nmol(-1) and increased to 2.2 mmol· min(-1)·nmol(-1) postoperatively (p < 0.001). Mean C-peptide AUC was 488 pmol·nmol(-1) and increased to 777 pmol· nmol(-1) (p = 0.37). The disposition index increased from 9.4 to 36.4 postoperatively (p = 0.01). CONCLUSIONS: According to the clamp technique, II-SG significantly improved IS and ß-cell function as early as 30 days postoperatively in a T2DM population with a BMI of 21.9-33.8.
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Glicemia/metabolismo , Diabetes Mellitus Tipo 2/fisiopatologia , Gastrectomia , Íleo/cirurgia , Resistência à Insulina/fisiologia , Células Secretoras de Insulina/fisiologia , Adulto , Área Sob a Curva , Cirurgia Bariátrica , Índice de Massa Corporal , Peptídeo C/sangue , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/cirurgia , Feminino , Técnica Clamp de Glucose , Teste de Tolerância a Glucose , Humanos , Insulina/sangue , Laparoscopia , Masculino , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/fisiopatologia , Obesidade/cirurgia , Período Pós-Operatório , Período Pré-Operatório , Estudos Prospectivos , Redução de PesoRESUMO
BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) from Latin American countries face challenges in access to healthcare, leading to under-diagnosis, under-achievement of glycemic target, and long-term complications. Early diagnosis and treatment initiation are of paramount importance in this population due to the high prevalence of risk factors such as obesity and metabolic syndrome. The VERIFY study in patients with newly diagnosed T2DM (across 34 countries), assessed the normoglycemic durability (5 years), with early combination (EC) therapy approach versus the traditional stepwise approach of initiating treatment with metformin monotherapy (MET). Here we present the results from the VERIFY study for participants from eight countries in Latin America. METHODS: Newly diagnosed adult patients with T2DM, HbA1c 6.5-7.5% and body-mass index (BMI) of 22-40 kg/m2 were enrolled. The primary endpoint was time to initial treatment failure (TF; HbA1c ≥ 7.0% at two consecutive scheduled visits 13 weeks apart). Time to second TF was evaluated when patients in both groups were receiving and failing on the vildagliptin combination. Safety and tolerability were also assessed for both treatment approaches during the study. RESULTS: A total of 537 eligible patients (female, 58.8%) were randomly assigned to receive either EC (n = 266) or MET (n = 271). EC significantly reduced the relative risk of time to initial TF by 47% versus MET [HR (95% CI) 0.53 (0.4, 0.7) p < 0.0001]. Overall, 46.4% versus 66.3% of patients achieved the primary endpoint in the EC and MET groups, with a median [interquartile range (IQR)] time to TF of 59.8 (27.5, not evaluable) and 33.4 (12.2, 60.1) months, respectively. The risk for time to second TF was 31% lower with EC (p < 0.0092). A higher proportion of patients receiving EC maintained durable HbA1c < 7.0%, < 6.5%, and < 6.0%. Both treatment approaches were well tolerated, and only 3.2% of participants discontinued the study due to adverse events. All hypoglycemic events (EC: n = 7 and MET: n = 3) were single, mild episodes and did not lead to study discontinuation. CONCLUSION: Similar to the global population, long-term clinical benefits were achieved more frequently and without tolerability issues with EC versus standard-of-care MET in this Latin American sub-population. This study is registered with ClinicalTrials.gov, NCT01528254.
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Introduction: Acupuncture is a widely used technique for the treatment of diabetes in Asian countries. Nevertheless, there are few studies with appropriate methodological rigor evaluating its effectiveness and promoting a standardized procedure in the Western World. Objectives: Evaluate the short-term effect of acupuncture in the treatment of type 2 diabetes mellitus (DM2) using continuous glucose monitoring (CGM). Methods: In a randomized controlled prospective open-label study, we assigned 20 insulin-independent DM2 patients to undergo acupuncture (group 1) or control group (group 2). Participants underwent CGM for 14 days. In group 1, all patients were submitted to acupuncture 4, 8, and 12 days after installation of the monitoring system. Diabetes-specific treatment points were used in all patients (bladder 38, large intestine 4, kidney 24, stomach 36, and spleen 9). This study was approved by the ethics committee (CAAE-60576616.6.0000.5572). Results: There were no statistically significant differences in the baseline characteristics. In group 1, mean glucose level obtained through 14 days monitoring after acupuncture treatment was 143 ± 28.8 mg/dL, whereas in group 2, who did not receive acupuncture, the mean level was 165.8 ± 30.2 mg/dL (P = 0.015). Conclusion: In this randomized pilot study, there was an improvement in global glycemic control during the 14-day monitoring in the acupuncture group. Further studies with larger cohorts over a more extended period of time are needed. Clinical Trials: RBR-3m45y3.
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The treatment aims for type 2 diabetes are to prevent complications and premature mortality, and improve quality of life. Glycaemic control is central to these aims; clinical guidelines have sought to achieve this with a stepwise approach starting with lifestyle measures and metformin, adding further medications once glycated haemoglobin (HbA1c) levels rise above a predefined threshold. However, treatment intensification can be delayed when HbA1c levels increase, and HbA1c levels become inadequately controlled in many patients. Clinical inertia can result in sustained elevated levels of HbA1c; when combined with a late diagnosis, this negatively impacts patients' prognosis. Early combination therapy using medications with complementary modes of action could achieve optimal glycaemic targets and alter the course of the disease more than metformin alone. The multinational VERIFY study (clinicaltrials.gov NCT01528254) provided evidence accrued over 5 years, demonstrating the potential of early combination therapy: time to loss of glycaemic control was nearly doubled, and more than twice the number of patients experienced extended glycaemic control, with a vildagliptin-metformin combination therapy versus metformin alone. The study also showed a delay in secondary treatment failure in patients receiving the combination. Early combination therapy therefore offers a different trajectory to the stepwise approach. Translating these findings into clinical practice will require early detection and diagnosis of type 2 diabetes plus a shift in disease management. Nonetheless, the potential benefits of sustained and continuous disease control that early combination therapy offers represent the start of a new era in early diagnosis and intensive management, to achieve the treatment aims of type 2 diabetes.
Blood glucose progressively increases over time in type 2 diabetes and is currently treated in a stepwise fashion, with more medications added when a single treatment fails. The VERIFY trial studied people with newly or recently diagnosed type 2 diabetes. Treating people early with two glucose-lowering drugs given together could slow the worsening of blood glucose levels, compared with starting with metformin first and then adding a second treatment later. Taking the two treatments together was as well tolerated as taking the single treatment alone. Starting treatment with two glucose-lowering drugs given together lengthened the time before insulin was needed, compared with starting with metformin and then adding a second treatment later. This is important to people with diabetes, as early treatment is straightforward but becomes increasingly complicated in later stages. The long-term benefits of this early combination treatment are awaited. In the meantime, the VERIFY trial has shown that combination therapy given at the start of treatment with medication can improve blood glucose levels and delay the need for insulin.
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Diabetic kidney disease (DKD) is one of the most frequent and dangerous complications of diabetes mellitus type 2, affecting about onethird of the patients. DKD results in increased hospitalizations and mortality rates, especially due to cardiovascular complications. This high burden of kidney disease is mainly due to the increasing complexity of in- outpatient care for patients with DM. There is a strikingly complex interaction of kidney dysfunction with many aspects of diabetes care, such as redefinition of targets of treatment, interactions of traditional and nontraditional risk factors, and pharmacological issues related to pharmacokinetic and side effects of drugs. Particularly when not carefully managed, DKD increases the demand for renal replacement therapies, such as dialysis and kidney transplants. The combined economic and social costs of this disease are high and of concern to the world's health systems. The main objective of this review is to provide insight into the recommendations for the evaluation and stratification of DKD and how the presence of kidney disease changes the optimal management of diabetic patients from an integrated renalcardioendocrine perspective.
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Diabetes Mellitus Tipo 2/terapia , Nefropatias Diabéticas/terapia , Automonitorização da Glicemia , Pressão Sanguínea , Sistema Endócrino , Fibrinolíticos/uso terapêutico , Inibidores de Glicosídeo Hidrolases/uso terapêutico , Coração/fisiopatologia , Homeostase , Humanos , Hiperglicemia/tratamento farmacológico , Hipoglicemia/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Rim/fisiopatologia , Metformina/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Compostos de Sulfonilureia/uso terapêutico , alfa-GlucosidasesRESUMO
BACKGROUND: Type 2 diabetes mellitus (T2DM) is a complex disease, particularly in a continental country like Brazil. We attempted to understand and evaluate the perceptions and routines of Brazilians with T2DM and physicians, compared with other countries. METHODS: We compared the results from a 20-min online survey in Brazil with simultaneously collated data from India, Japan, Spain, UK and USA. RESULTS: In total, 652 adults with T2DM and 337 treating physicians were enrolled, of whom 100 patients and 55 physicians were from Brazil. The numbers of primary care physicians from the five countries were 221 versus 43 in Brazil, diabetes specialists were 61 versus 12. There was disconnect between the opinions of physicians and people with diabetes globally. Further, there were differences between clinical practices in Brazil versus the rest of the world, in many areas Brazilians were performing better. CONCLUSIONS: Communication between patients and physicians should be clearer. There is an urgent need to identify the deficits in education, in order to address the clinical inertia within the diabetes management team. There is a necessity to understand the specific requirements of the Brazilian population in order to contextualise international guidelines and implement local changes in practice.
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BACKGROUND: Since the first position statement on diabetes and cardiovascular prevention published in 2014 by the Brazilian Diabetes Society, the current view on primary and secondary prevention in diabetes has evolved as a result of new approaches on cardiovascular risk stratification, new cholesterol lowering drugs, and new anti-hyperglycemic drugs. Importantly, a pattern of risk heterogeneity has emerged, showing that not all diabetic patients are at high or very high risk. In fact, most younger patients who have no overt cardiovascular risk factors may be more adequately classified as being at intermediate or even low cardiovascular risk. Thus, there is a need for cardiovascular risk stratification in patients with diabetes. The present panel reviews the best current evidence and proposes a practical risk-based approach on treatment for patients with diabetes. MAIN BODY: The Brazilian Diabetes Society, the Brazilian Society of Cardiology, and the Brazilian Endocrinology and Metabolism Society gathered to form an expert panel including 28 cardiologists and endocrinologists to review the best available evidence and to draft up-to-date an evidence-based guideline with practical recommendations for risk stratification and prevention of cardiovascular disease in diabetes. The guideline includes 59 recommendations covering: (1) the impact of new anti-hyperglycemic drugs and new lipid lowering drugs on cardiovascular risk; (2) a guide to statin use, including new definitions of LDL-cholesterol and in non-HDL-cholesterol targets; (3) evaluation of silent myocardial ischemia and subclinical atherosclerosis in patients with diabetes; (4) hypertension treatment; and (5) the use of antiplatelet therapy. CONCLUSIONS: Diabetes is a heterogeneous disease. Although cardiovascular risk is increased in most patients, those without risk factors or evidence of sub-clinical atherosclerosis are at a lower risk. Optimal management must rely on an approach that will cover both cardiovascular disease prevention in individuals in the highest risk as well as protection from overtreatment in those at lower risk. Thus, cardiovascular prevention strategies should be individualized according to cardiovascular risk while intensification of treatment should focus on those at higher risk.
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BACKGROUND: Type 2 diabetes mellitus (DM) globally affects 18-20 % of adults over the age of 65 years. Diabetic kidney disease (DKD) is one of the most frequent and dangerous complications of DM2, affecting about one-third of the patients with DM2. In addition to the pancreas, adipocytes, liver, and intestines, the kidneys also play an important role in glycemic control, particularly due to renal contribution to gluconeogenesis and tubular reabsorption of glucose. METHODS: In this review article, based on a report of discussions from an interdisciplinary group of experts in the areas of endocrinology, diabetology and nephrology, we detail the relationship between diabetes and kidney disease, addressing the care in the diagnosis, the difficulties in achieving glycemic control and possible treatments that can be applied according to the different degrees of impairment. DISCUSSION: Glucose homeostasis is extremely altered in patients with DKD, who are exposed to a high risk of both hyperglycemia and hypoglycemia. Both high and low glycemic levels are associated with increased morbidity and shortened survival in this group of patients. Factors that are associated with an increased risk of hypoglycemia in DKD patients include decreased renal gluconeogenesis, deranged metabolic pathways (including altered metabolism of medications) and decreased insulin clearance. On the other hand, decrease glucose filtration and excretion, and inflammation-induce insulin resistance are predisposing factors to hyperglycemic episodes. CONCLUSION: Appropriate glycaemic monitoring and control tailored for diabetic patients is required to avoid hypoglycaemia and other glycaemic disarrays in patients with DM2 and kidney disease. Understanding the renal physiology and pathophysiology of DKD has become essential to all specialties treating diabetic patients. Disseminating this knowledge and detailing the evidence will be important to initiate breakthrough research and to encourage proper treatment of this group of patients.
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BACKGROUND: The objective of this study was to evaluate the mid-term outcomes of the laparoscopic ileal interposition into the jejunum (JII-SG) or into the duodenum (DII-SG) associated with sleeve gastrectomy for type 2 diabetes mellitus (T2DM) patients with BMI below 35. METHODS: The procedures were performed on 202 consecutive patients. Mean age was 52.2 ± 7.5. Mean duration of T2DM was 9.8 ± 5.2 years. Insulin therapy was used by 41.1%. Dyslipidemia was observed in 78.2%, hypertension in 67.3%, nephropathy in 49.5%, retinopathy in 31.2%, coronary heart disease in 11.9%, and other cardiovascular events in 12.9%. RESULTS: Mean follow-up was 39.1 months (range, 25-61). Early and late mortality was 0.99% and 1.0%, respectively. Early reoperation was performed in 2.5%. Early and late major complications were 8.4% and 3.5%. Early most frequent complications were pneumonia and ileus. Intestinal obstruction was diagnosed in 1.5%. Mean BMI decreased from 29.7 to 23.5 kg/m(2), mean fasting glucose from 202.1 to 112.2 mg/dl, and mean postprandial glucose from 263.3 to 130 mg/dl. Triglycerides diminished from a mean of 273.4 to 110.3 mg/dl and cholesterol from a mean of 204.7 to 160.1 mg/dl. Hypertension was resolved in 87.5%. Mean hemoglobin A(1c) (HbA(1c)) decreased from 8.7 to 6.2% after the JII-SG and to 5.9% following the DII-SG. HbA(1c) below 7% was seen in 89.9% of the patients and below 6.5% in 78.3%. Overall, 86.4% of patients were off antidiabetic medications. CONCLUSION: Both JII-SG and DII-SG demonstrated to be safe, effective, and long-lasting alternatives for the treatment of T2DM patients with BMI <35. Beyond glycemic control, other benefits were achieved.
Assuntos
Diabetes Mellitus Tipo 2/cirurgia , Gastrectomia/métodos , Laparoscopia/métodos , Obesidade/cirurgia , Adulto , Análise de Variância , Anastomose Cirúrgica/métodos , Índice de Massa Corporal , Estudos de Coortes , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Duodeno/cirurgia , Feminino , Seguimentos , Gastrectomia/efeitos adversos , Humanos , Íleo/cirurgia , Jejuno/cirurgia , Laparoscopia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/diagnóstico , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/fisiopatologia , Estudos Retrospectivos , Medição de Risco , Resultado do TratamentoAssuntos
Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Cardiomiopatias Diabéticas/prevenção & controle , Medicina Baseada em Evidências/normas , Brasil , LDL-Colesterol , Cardiomiopatias Diabéticas/etiologia , Humanos , Hipercolesterolemia/complicações , Medição de Risco , Fatores de Risco , Sociedades MédicasRESUMO
Resumo Fundamentação: desde o primeiro posicionamento da Sociedade Brasileira de Diabetes (SBD) sobre diabetes e prevenção cardiovascular, em 2014,1 importantes estudos têm sido publicados na área de prevenção cardiovascular e tratamento do diabetes,2 os quais contribuíram para a evolução na prevenção primária e secundária nos pacientes com diabetes. Ferramentas de estratificação de risco mais precisas, novos fármacos hipolipemiantes e novos antidiabéticos com efeitos cardiovasculares e redução da mortalidade, são parte desta nova abordagem para os pacientes com diabetes. O reconhecimento de que o diabetes é uma doença heterogênea foi fundamental, sendo claramente demonstrado que nem todos os pacientes diabéticos pertencem a categorias de risco alto ou muito alto. Um porcentual elevado é composto por pacientes jovens, sem os fatores de risco clássicos, os quais podem ser classificados adequadamente em categorias de risco intermediário ou mesmo em baixo risco cardiovascular. O presente posicionamento revisa as melhores evidências atualmente disponíveis e propõe uma abordagem prática, baseada em risco, para o tratamento de pacientes com diabetes. Estruturação: perante este desafio e reconhecendo a natureza multifacetada da doença, a SBD uniu-se à Sociedade Brasileira de Cardiologia (SBC) e à Sociedade Brasileira de Endocrinologia e Metabolismo (SBEM), e formou um painel de especialistas, constituído por 28 cardiologistas e endocrinologistas, para revisar as melhores evidências disponíveis e elaborar uma diretriz contendo recomendações práticas para a estratificação de risco e prevenção da Doença Cardiovascular (DVC) no Diabetes Melito (DM). As principais inovações incluem: (1) considerações do impacto de novos hipolipemiantes e das novas medicações antidiabéticas no risco cardiovascular; (2) uma abordagem prática, baseada em fator de risco, para orientar o uso das estatinas, incluindo novas definições das metas da Lipoproteína de Baixa Densidade-colesterol (LDL-colesterol) e colesterol não Lipoproteína de Alta Densidade HDL; (3) uma abordagem baseada em evidências, para avaliar a isquemia miocárdica silenciosa (IMS) e a aterosclerose subclínica em pacientes com diabetes; (4) as abordagens mais atuais para o tratamento da hipertensão; e (5) recomendação de atualizações para o uso de terapia antiplaquetária. Esperamos que esta diretriz auxilie os médicos no cuidado dedicado aos pacientes com diabetes. Métodos: inicialmente, os membros do painel foram divididos em sete subcomitês para definirem os tópicos principais que necessitavam de uma posição atualizada das sociedades. Os membros do painel pesquisaram e buscaram no PubMed estudos clínicos randomizados e metanálises de estudos clínicos e estudos observacionais de boa qualidade, publicados entre 1997 e 2017, usando termos MeSH: [diabetes], [diabetes tipo 2], [doença cardiovascular], [estratificação de risco cardiovascular] [doença arterial coronária], [rastreamento], [isquemia silenciosa], [estatinas], [hipertensão], [ácido acetilsalicílico]. Estudos observacionais de baixa qualidade, metanálises com alta heterogeneidade e estudos transversais não foram incluídos, embora talvez tenham impactado no Nível de Evidência indicado. A opinião de especialistas foi usada quando os resultados das buscas não eram satisfatórios para um item específico. É importante salientar que este posicionamento não teve a intenção de incluir uma revisão sistemática rigorosa. Um manuscrito preliminar, destacando recomendações de graus e níveis de evidência (Quadro 1), foi esboçado. Este passo levou a várias discussões entre os membros dos subcomitês, que revisaram os achados e fizeram novas sugestões. O manuscrito foi, então, revisto pelo autor líder, encarregado da padronização do texto e da inclusão de pequenas alterações, sendo submetido à apreciação mais detalhada pelos membros dos comitês, buscando uma posição de consenso. Depois desta fase, o manuscrito foi enviado para a banca editorial e edição final, sendo encaminhado para publicação. Quadro 1 Graus de recomendações e níveis de evidências adotados nesta revisão Grau de recomendação Classe I A evidência é conclusiva ou, se não, existe consenso de que o procedimento ou tratamento é seguro e eficaz Classe II Há evidências contraditórias ou opiniões divergentes sobre segurança, eficácia, ou utilidade do tratamento ou procedimento Classe IIa As opiniões são favoráveis ao tratamento ou procedimento. A maioria dos especialistas aprova Classe IIb A eficácia é bem menos estabelecida, e as opiniões são divergentes Classe III Há evidências ou consenso de que o tratamento ou procedimento não é útil, eficaz, ou pode ser prejudicial Níveis de Evidência A Múltiplos estudos clínicos randomizados concordantes e bem elaborados ou metanálises robustas de estudos clínicos randomizados B Dados de metanálises menos robustas, um único estudo clínico randomizado ou estudos observacionais C Opinião dos especialistas