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1.
Diabetes Obes Metab ; 26(7): 2624-2633, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38603589

RESUMO

AIM: To develop and employ machine learning (ML) algorithms to analyse electrocardiograms (ECGs) for the diagnosis of cardiac autonomic neuropathy (CAN). MATERIALS AND METHODS: We used motif and discord extraction techniques, alongside long short-term memory networks, to analyse 12-lead, 10-s ECG tracings to detect CAN in patients with diabetes. The performance of these methods with the support vector machine classification model was evaluated using 10-fold cross validation with the following metrics: accuracy, precision, recall, F1 score, and area under the receiver-operating characteristic curve (AUC). RESULTS: Among 205 patients (mean age 54 ± 17 years, 54% female), 100 were diagnosed with CAN, including 38 with definite or severe CAN (dsCAN) and 62 with early CAN (eCAN). The best model performance for dsCAN classification was achieved using both motifs and discords, with an accuracy of 0.92, an F1 score of 0.92, a recall at 0.94, a precision of 0.91, and an excellent AUC of 0.93 (95% confidence interval [CI] 0.91-0.94). For the detection of any stage of CAN, the approach combining motifs and discords yielded the best results, with an accuracy of 0.65, F1 score of 0.68, a recall of 0.75, a precision of 0.68, and an AUC of 0.68 (95% CI 0.54-0.81). CONCLUSION: Our study highlights the potential of using ML techniques, particularly motifs and discords, to effectively detect dsCAN in patients with diabetes. This approach could be applied in large-scale screening of CAN, particularly to identify definite/severe CAN where cardiovascular risk factor modification may be initiated.


Assuntos
Inteligência Artificial , Neuropatias Diabéticas , Eletrocardiografia , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Neuropatias Diabéticas/diagnóstico , Neuropatias Diabéticas/fisiopatologia , Eletrocardiografia/métodos , Adulto , Idoso , Algoritmos , Aprendizado de Máquina , Máquina de Vetores de Suporte , Doenças do Sistema Nervoso Autônomo/diagnóstico , Doenças do Sistema Nervoso Autônomo/fisiopatologia , Cardiomiopatias Diabéticas/diagnóstico
2.
Cardiovasc Diabetol ; 22(1): 218, 2023 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-37620935

RESUMO

AIMS: As cardiovascular disease (CVD) is a leading cause of death for patients with diabetes mellitus (DM), we aimed to find important factors that predict cardiovascular (CV) risk using a machine learning (ML) approach. METHODS AND RESULTS: We performed a single center, observational study in a cohort of 238 DM patients (mean age ± SD 52.15 ± 17.27 years, 54% female) as a part of the Silesia Diabetes-Heart Project. Having gathered patients' medical history, demographic data, laboratory test results, results from the Michigan Neuropathy Screening Instrument (assessing diabetic peripheral neuropathy) and Ewing's battery examination (determining the presence of cardiovascular autonomic neuropathy), we managed use a ML approach to predict the occurrence of overt CVD on the basis of five most discriminative predictors with the area under the receiver operating characteristic curve of 0.86 (95% CI 0.80-0.91). Those features included the presence of past or current foot ulceration, age, the treatment with beta-blocker (BB) and angiotensin converting enzyme inhibitor (ACEi). On the basis of the aforementioned parameters, unsupervised clustering identified different CV risk groups. The highest CV risk was determined for the eldest patients treated in large extent with ACEi but not BB and having current foot ulceration, and for slightly younger individuals treated extensively with both above-mentioned drugs, with relatively small percentage of diabetic ulceration. CONCLUSIONS: Using a ML approach in a prospective cohort of patients with DM, we identified important factors that predicted CV risk. If a patient was treated with ACEi or BB, is older and has/had a foot ulcer, this strongly predicts that he/she is at high risk of having overt CVD.


Assuntos
Doenças Cardiovasculares , Diabetes Mellitus , Neuropatias Diabéticas , Humanos , Feminino , Masculino , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Estudos Prospectivos , Fatores de Risco , Inibidores da Enzima Conversora de Angiotensina , Fatores de Risco de Doenças Cardíacas , Aprendizado de Máquina , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia
3.
Cardiovasc Diabetol ; 22(1): 318, 2023 11 20.
Artigo em Inglês | MEDLINE | ID: mdl-37985994

RESUMO

BACKGROUND: Diabetes mellitus (DM), heart failure (HF) and metabolic dysfunction associated steatotic liver disease (MASLD) are overlapping diseases of increasing prevalence. Because there are still high numbers of patients with HF who are undiagnosed and untreated, there is a need for improving efforts to better identify HF in patients with DM with or without MASLD. This study aims to develop machine learning (ML) models for assessing the risk of the HF occurrence in patients with DM with and without MASLD. RESEARCH DESIGN AND METHODS: In the Silesia Diabetes-Heart Project (NCT05626413), patients with DM with and without MASLD were analyzed to identify the most important HF risk factors with the use of a ML approach. The multiple logistic regression (MLR) classifier exploiting the most discriminative patient's parameters selected by the χ2 test following the Monte Carlo strategy was implemented. The classification capabilities of the ML models were quantified using sensitivity, specificity, and the percentage of correctly classified (CC) high- and low-risk patients. RESULTS: We studied 2000 patients with DM (mean age 58.85 ± SD 17.37 years; 48% women). In the feature selection process, we identified 5 parameters: age, type of DM, atrial fibrillation (AF), hyperuricemia and estimated glomerular filtration rate (eGFR). In the case of MASLD( +) patients, the same criterion was met by 3 features: AF, hyperuricemia and eGFR, and for MASLD(-) patients, by 2 features: age and eGFR. Amongst all patients, sensitivity and specificity were 0.81 and 0.70, respectively, with the area under the receiver operating curve (AUC) of 0.84 (95% CI 0.82-0.86). CONCLUSION: A ML approach demonstrated high performance in identifying HF in patients with DM independently of their MASLD status, as well as both in patients with and without MASLD based on easy-to-obtain patient parameters.


Assuntos
Fibrilação Atrial , Diabetes Mellitus , Fígado Gorduroso , Insuficiência Cardíaca , Hiperuricemia , Doenças Metabólicas , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/etiologia , Fatores de Risco , Aprendizado de Máquina
4.
Cardiovasc Diabetol ; 21(1): 203, 2022 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-36209118

RESUMO

BACKGROUND: Guidelines from 2016 onwards recommend early use of SGLT2i or GLP-1 RA for patients with type 2 diabetes (T2D) and cardiovascular disease (CVD), to reduce CV events and mortality. Many eligible patients are not treated accordingly, although data are lacking for Central and Eastern Europe (CEE). METHODS: The CORDIALLY non-interventional study evaluated the real-world characteristics, modern antidiabetic treatment patterns, and the prevalence of CVD and chronic kidney disease (CKD) in adults with T2D at nonhospital-based practices in CEE. Data were retrospectively collated by medical chart review for patients initiating empagliflozin, another SGLT2i, DPP4i, or GLP-1 RA in autumn 2018. All data were analysed cross-sectionally, except for discontinuations assessed 1 year ± 2 months after initiation. RESULTS: Patients (N = 4055) were enrolled by diabetologists (56.7%), endocrinologists (40.7%), or cardiologists (2.5%). Empagliflozin (48.5%) was the most prescribed medication among SGLT2i, DPP4i, and GLP-1 RA; > 3 times more patients were prescribed empagliflozin than other SGLT2i (10 times more by cardiologists). Overall, 36.6% of patients had diagnosed CVD. Despite guidelines recommending SGLT2i or GLP-1 RA, 26.8% of patients with CVD received DPP4i. Patients initiating DPP4i were older (mean 66.4 years) than with SGLT2i (62.4 years) or GLP-1 RA (58.3 years). CKD prevalence differed by physician assessment (14.5%) or based on eGFR and UACR (27.9%). Many patients with CKD (≥ 41%) received DPP4i, despite guidelines recommending SGLT2is owing to their renal benefits. 1 year ± 2-months after initiation, 10.0% (7.9-12.3%) of patients had discontinued study medication: 23.7-45.0% due to 'financial burden of co-payment', 0-1.9% due to adverse events (no patients discontinued DPP4i due to adverse events). Treatment guidelines were 'highly relevant' for a greater proportion of cardiologists (79.4%) and endocrinologists (72.9%) than diabetologists (56.9%), and ≤ 20% of physicians consulted other physicians when choosing and discontinuing treatments. CONCLUSIONS: In CORDIALLY, significant proportions of patients with T2D and CVD/CKD who initiated modern antidiabetic medication in CEE in autumn 2018 were not treated with cardioprotective T2D medications. Use of DPP4i instead of SGLT2i or GLP-1 RA may be related to lack of affordable access, the perceived safety of these medications, lack of adherence to the latest treatment guidelines, and lack of collaboration between physicians. Thus, many patients with T2D and comorbidities may develop preventable complications or die prematurely. Trial registration NCT03807440.


Assuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Insuficiência Renal Crônica , Inibidores do Transportador 2 de Sódio-Glicose , Adulto , Compostos Benzidrílicos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Estudos Transversais , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Peptídeo 1 Semelhante ao Glucagon/uso terapêutico , Receptor do Peptídeo Semelhante ao Glucagon 1 , Glucosídeos , Humanos , Hipoglicemiantes/efeitos adversos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/tratamento farmacológico , Insuficiência Renal Crônica/epidemiologia , Estudos Retrospectivos , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos
5.
Cardiovasc Diabetol ; 21(1): 240, 2022 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-36371249

RESUMO

BACKGROUND: Nonalcoholic fatty liver disease is associated with an increased cardiovascular disease (CVD) risk, although the exact mechanism(s) are less clear. Moreover, the relationship between newly redefined metabolic-associated fatty liver disease (MAFLD) and CVD risk has been poorly investigated. Data-driven machine learning (ML) techniques may be beneficial in discovering the most important risk factors for CVD in patients with MAFLD. METHODS: In this observational study, the patients with MAFLD underwent subclinical atherosclerosis assessment and blood biochemical analysis. Patients were split into two groups based on the presence of CVD (defined as at least one of the following: coronary artery disease; myocardial infarction; coronary bypass grafting; stroke; carotid stenosis; lower extremities artery stenosis). The ML techniques were utilized to construct a model which could identify individuals with the highest risk of CVD. We exploited the multiple logistic regression classifier operating on the most discriminative patient's parameters selected by univariate feature ranking or extracted using principal component analysis (PCA). Receiver operating characteristic (ROC) curves and area under the ROC curve (AUC) were calculated for the investigated classifiers, and the optimal cut-point values were extracted from the ROC curves using the Youden index, the closest to (0, 1) criteria and the Index of Union methods. RESULTS: In 191 patients with MAFLD (mean age: 58, SD: 12 years; 46% female), there were 47 (25%) patients who had the history of CVD. The most important clinical variables included hypercholesterolemia, the plaque scores, and duration of diabetes. The five, ten and fifteen most discriminative parameters extracted using univariate feature ranking and utilized to fit the ML models resulted in AUC of 0.84 (95% confidence interval [CI]: 0.77-0.90, p < 0.0001), 0.86 (95% CI 0.80-0.91, p < 0.0001) and 0.87 (95% CI 0.82-0.92, p < 0.0001), whereas the classifier fitted over 10 principal components extracted using PCA followed by the parallel analysis obtained AUC of 0.86 (95% CI 0.81-0.91, p < 0.0001). The best model operating on 5 most discriminative features correctly identified 114/144 (79.17%) low-risk and 40/47 (85.11%) high-risk patients. CONCLUSION: A ML approach demonstrated high performance in identifying MAFLD patients with prevalent CVD based on the easy-to-obtain patient parameters.


Assuntos
Doenças Cardiovasculares , Hepatopatias , Hepatopatia Gordurosa não Alcoólica , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Fatores de Risco , Aprendizado de Máquina , Fatores de Risco de Doenças Cardíacas , Hepatopatias/complicações , Hepatopatia Gordurosa não Alcoólica/complicações
6.
Medicina (Kaunas) ; 58(3)2022 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-35334574

RESUMO

Background and objectives: Gestational diabetes mellitus (GDM) is a significant risk factor of maternal and fetal complications. The aim of the study was to compare two groups of patients with GDM treated in 2015/2016 (Group-15/16), and in 2017/2018 (Group-17/18) and to answer the question whether the change in the diagnostic criteria for GDM affected maternal and fetal complications. Materials and Methods: A retrospective analysis was conducted. The study included 123 patients with GDM (58 patients/Group-15/16 and 65 patients/Group-17/18). Results: No significant differences were found between the groups. In Group-17/18, GDM was significantly more often diagnosed based on fasting glycemia (33.8%) compared with Group-15/16 (22.4%; p = 0.000001). GDM was significantly more often diagnosed based on 2-h oral glucose tolerance test (OGTT; 44.8%) compared with Group-17/18 (29.2%; p = 0.000005). In Group-15/16, insulin was started in 51.7% of patients compared with 33.8% in Group-17/18 (p = 0.04287). Despite more frequent insulin therapy in Group-15/16, insulin was started later (30th week of gestation) and significantly more frequently in older patients and those with higher BMI values compared with Group-17/18 (27th week of pregnancy). The number of caesarean sections and spontaneous deliveries was also similar in both periods. No difference was found in the prevalence of neonatal complications, including neonatal hypo-glycemia, prolonged jaundice or heart defect. In addition, no differences were found between the parameters in newborns. Conclusions: The change in the criteria for the diagnosis and treatment of GDM translated into the mode of diagnosis and currently it is more often diagnosed based on abnormal fasting glycemia. Currently, a lower percentage of patients require insulin therapy. However, less frequent inclusion of insulin may result in higher postprandial glycemia in the third trimester of pregnancy in mothers, thus increasing the risk of neonatal hypoglycemia immediately after delivery.


Assuntos
Diabetes Gestacional , Idoso , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/epidemiologia , Feminino , Teste de Tolerância a Glucose , Humanos , Recém-Nascido , Polônia/epidemiologia , Gravidez , Estudos Prospectivos , Estudos Retrospectivos
7.
Eur J Clin Invest ; 51(3): e13385, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32810282

RESUMO

INTRODUCTION: Atrial fibrillation (AF) and diabetes mellitus (DM) constitute a heavy burden on healthcare expenditure due to their negative impact on clinical outcomes in the Middle East. The Atrial fibrillation Better Care (ABC) pathway provides a simple strategy of integrated approach of AF management: A-Avoid stroke; B-Better symptom control; C-Cardiovascular comorbidity risk management. AIMS: Evaluation of the AF treatment compliance to ABC pathway in DM patients in the Middle East. Assessment of the impact of ABC pathway adherence on all-cause mortality and the composite outcome of stroke/systemic embolism, all-cause death and cardiovascular hospitalisations. METHODS: From 2043 patients in the Gulf SAFE registry, 603 patients (mean age 63; 48% male) with DM were included in an analysis of ABC pathway compliance: A-appropriate use of anticoagulation according to CHA2 DS2 -VASc score; B-AF symptoms management according to the European Heart Rhythm Association (EHRA) scale; C-Optimised cardiovascular comorbidities management. RESULTS: 86 (14.3%) patients were treated in compliance with the ABC pathway. During 1-year follow-up, 207 composite outcome events and 87 deaths occurred. Mortality was significantly lower in the ABC group vs non-ABC (5.8% vs 15.9%, P = .0014, respectively). On multivariate analysis, ABC compliance was associated with a lower risk of all-cause death and the composite outcome after 6 months (OR 0.18; 95% CI: 0.42-0.75 and OR 0.54; 95% Cl: 0.30-1.00, respectively) and at 1 year (OR 0.30; 95% Cl: 0.11-0.76 and OR 0.57; 95% Cl: 0.33-0.97, respectively) vs the non-ABC group. CONCLUSIONS: Compliance with the ABC pathway care was independently associated with the reduced risk of all-cause death and the composite outcome in DM patients with AF, highlighting the importance of an integrated approach to AF management.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Complicações do Diabetes , Diabetes Mellitus , Inibidores da Agregação Plaquetária/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/fisiopatologia , Doenças Cardiovasculares , Causas de Morte , Embolia/etiologia , Embolia/prevenção & controle , Feminino , Fidelidade a Diretrizes , Fatores de Risco de Doenças Cardíacas , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Oriente Médio , Mortalidade , Guias de Prática Clínica como Assunto , Sistema de Registros , Acidente Vascular Cerebral/etiologia
8.
Int J Mol Sci ; 22(19)2021 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-34639160

RESUMO

The incidence of type 2 diabetes (T2D) has been increasing worldwide, and diabetic kidney disease (DKD) remains one of the leading long-term complications of T2D. Several lines of evidence indicate that glucose-lowering agents prevent the onset and progression of DKD in its early stages but are of limited efficacy in later stages of DKD. However, sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor (GLP-1R) agonists were shown to exert nephroprotective effects in patients with established DKD, i.e., those who had a reduced glomerular filtration rate. These effects cannot be solely attributed to the improved metabolic control of diabetes. In our review, we attempted to discuss the interactions of both groups of agents with inflammation and oxidative stress­the key pathways contributing to organ damage in the course of diabetes. SGLT2i and GLP-1R agonists attenuate inflammation and oxidative stress in experimental in vitro and in vivo models of DKD in several ways. In addition, we have described experiments showing the same protective mechanisms as found in DKD in non-diabetic kidney injury models as well as in some tissues and organs other than the kidney. The interaction between both drug groups, inflammation and oxidative stress appears to have a universal mechanism of organ protection in diabetes and other diseases.


Assuntos
Diabetes Mellitus Tipo 2/complicações , Nefropatias Diabéticas/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Inflamação/fisiopatologia , Estresse Oxidativo , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Nefropatias Diabéticas/etiologia , Nefropatias Diabéticas/patologia , Humanos
9.
Postepy Dermatol Alergol ; 37(6): 932-937, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33603612

RESUMO

INTRODUCTION: Even though uremic pruritus (UP) is very troublesome for haemodialysis (HD) patients, its underlying mechanism is not fully understood. AIM: Due to the possible role of brain-derived neurotrophic factor (BDNF) and its higher serum concentration in haemodialysis diabetic patients compared to non-diabetic ones, this study is aimed to evaluate its association with UP among diabetic and non-diabetic patients on maintenance HD. MATERIAL AND METHODS: A total of 94 patients were enrolled into the study. A visual analogue scale (VAS) was used to assess pruritus. RESULTS: No differences were found between the observed study groups in terms of BDNF serum concentration, other biochemical markers, sleep disturbances, or pruritus presentation. CONCLUSIONS: BDNF serum concentration was not found to be associated with UP among HD patients, however further studies are worth performing on a larger group of individuals.

10.
Cardiovasc Diabetol ; 18(1): 115, 2019 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-31472683

RESUMO

EMPA-REG OUTCOME is recognised by international guidelines as a landmark study that showed a significant cardioprotective benefit with empagliflozin in patients with type 2 diabetes (T2D) and cardiovascular disease. To assess the impact of empagliflozin in routine clinical practice, the ongoing EMPRISE study is collecting real-world evidence to compare effectiveness, safety and health economic outcomes between empagliflozin and DPP-4 inhibitors. A planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient population. In this commentary article, we discuss the new data in the context of current evidence and clinical guidelines, as clinicians experienced in managing cardiovascular risk in patients with T2D. We also look forward to what future insights EMPRISE may offer, as evidence is accumulated over the next years to complement the important findings of EMPA-REG OUTCOME.


Assuntos
Compostos Benzidrílicos/uso terapêutico , Doenças Cardiovasculares/terapia , Ensaios Clínicos como Assunto/métodos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Medicina Baseada em Evidências , Glucosídeos/uso terapêutico , Projetos de Pesquisa , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Compostos Benzidrílicos/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/mortalidade , Tomada de Decisão Clínica , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/mortalidade , Glucosídeos/efeitos adversos , Hospitalização , Humanos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Fatores de Proteção , Medição de Risco , Fatores de Risco , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Resultado do Tratamento
11.
Diabetes Obes Metab ; 21(3): 622-630, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30362250

RESUMO

AIMS: To investigate the association between day-to-day fasting self-monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and to compare day-to-day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). MATERIALS AND METHODS: Data were retrieved from two double-blind, randomized, treat-to-target, two-period (32 weeks each) crossover trials of degludec vs glargine U100 in T1D (SWITCH 1, n = 501) and T2D (SWITCH 2, n = 720). Available fasting SMBGs were used to determine the standard deviation (SD) of day-to-day fasting SMBG variability for each patient and the treatment combination. The association between day-to-day fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia was analysed for the pooled population using linear regression, with fasting SMBG variability included as a three-level factor defined by population tertiles. Finally, day-to-day fasting SMBG variability was compared between treatments. RESULTS: Linear regression showed that day-to-day fasting SMBG variability was significantly associated with overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D (P < 0.05). Day-to-day fasting SMBG variability was significantly associated (P < 0.01) with all categories of hypoglycaemia risk, with the exception of severe hypoglycaemia in T2D when analysed within tertiles. Degludec was associated with 4% lower day-to-day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day-to-day fasting SMBG variability in T2D (P < 0.0001). CONCLUSIONS: Higher day-to-day fasting SMBG variability is associated with an increased risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia. Degludec has significantly lower day-to-day fasting SMBG variability vs glargine U100.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Jejum/sangue , Hipoglicemia/induzido quimicamente , Insulina Glargina/efeitos adversos , Insulina de Ação Prolongada/efeitos adversos , Adolescente , Adulto , Glicemia/metabolismo , Automonitorização da Glicemia , Ritmo Circadiano/efeitos dos fármacos , Ritmo Circadiano/fisiologia , Estudos Cross-Over , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Método Duplo-Cego , Jejum/fisiologia , Feminino , Humanos , Hipoglicemia/sangue , Hipoglicemia/diagnóstico , Hipoglicemia/etiologia , Insulina Glargina/administração & dosagem , Insulina de Ação Prolongada/administração & dosagem , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
13.
JAMA ; 318(1): 33-44, 2017 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-28672316

RESUMO

IMPORTANCE: Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death. OBJECTIVE: To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period. INTERVENTIONS: Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment sequence. MAIN OUTCOMES AND MEASURES: The primary end point was the rate of overall severe or blood glucose-confirmed (<56 mg/dL) symptomatic hypoglycemic episodes during the maintenance period. Secondary end points included the rate of nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period. The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted. RESULTS: Of the 501 patients randomized (mean age, 45.9 years; 53.7% men), 395 (78.8%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001 for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per 100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%). CONCLUSIONS AND RELEVANCE: Among patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02034513.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina Glargina/uso terapêutico , Insulina de Ação Prolongada/uso terapêutico , Adulto , Glicemia/análise , Estudos Cross-Over , Diabetes Mellitus Tipo 1/sangue , Método Duplo-Cego , Feminino , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina Glargina/efeitos adversos , Insulina de Ação Prolongada/efeitos adversos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
14.
Biomedicines ; 12(4)2024 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-38672272

RESUMO

BACKGROUND: Postmenopausal osteoporosis is not only related to hormonal factors but is also associated with environmental and genetic factors. One of the latter is the polymorphism of vitamin D receptor (VDR). The aim of the reported study was to comprehensively analyze the VDR gene polymorphic variants rs731236 (TaqI), rs1544410 (BsmI) and rs7975232 (ApaI) in the Polish population of postmenopausal women. METHODS: The study group consisted of 611 women after menopause (their median age was 65.82 ± 6.29 years). Each of them underwent bone densitometry (DXA) of the non-dominant femoral neck and total hip with a biochemical analysis of vitamin D3 serum concentration and genotyping of the above-mentioned single nucleotide polymorphisms (SNPs); the obtained results were analyzed in the aspect of waist circumference (WC), body mass index (BMI) and past medical history. RESULTS: The genotype prevalence rates of all SNPs were compatible with Hardy-Weinberg equilibrium (p > 0.050). Out of the studied polymorphisms, only rs731236 genotype variants affected DXA, with AG heterozygotes showing the worst bone parameters. Neither patient age nor vitamin D3 concentration, BMI, WC or comorbidities was associated with rs731236 genotype. CONCLUSIONS: Out of the polymorphisms studied, only rs731236 genotypes differed among the DXA results, while the AG heterozygotes were characterized by the lowest median bone mineral density.

15.
J Cancer Res Clin Oncol ; 150(6): 295, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38844723

RESUMO

BACKGROUND: The DIAPH2 gene is one of the genes commonly associated with laryngeal squamous cell carcinoma (LSCC). In our study, we considered the four polymorphisms of this gene, i.e. rs5920828, rs4322175, rs12851931 and rs5921830 as potential genetic risk factors for LSCC. METHODS: We determined the genotyping of the genetic variants of DIAPH2 in 230 male patients with histologically confirmed LSCC compared to the European population. Demographic and environmental exposure data of each subject were examined. To conduct the genetic tests, extraction of total DNA was performed. We genotyped all four variants in each patient and determined their frequencies. RESULTS: In the case of the rs12851931 polymorphism in the DIAPH2 gene, a significant difference was observed in the distribution of the T stage depending on the polymorphism. Heterozygotes were more often associated with T2 stage, while homozygotes were more likely to have higher tumor stages. The rs12851931 homozygotes of DIAPH2 were statistically significantly more prevalent in smokers. The results suggested that rs12851931 polymorphism in DIAPH2 could increase the onset risk of LSCC. CONCLUSIONS: Our results provide further information on the role of the DIAPH2 gene in the pathogenesis of LSCC.


Assuntos
Forminas , Predisposição Genética para Doença , Neoplasias Laríngeas , Polimorfismo de Nucleotídeo Único , Humanos , Masculino , Neoplasias Laríngeas/genética , Neoplasias Laríngeas/epidemiologia , Neoplasias Laríngeas/patologia , Pessoa de Meia-Idade , Forminas/genética , Idoso , Carcinoma de Células Escamosas/genética , Carcinoma de Células Escamosas/patologia , Fatores de Risco , Genótipo , Adulto
16.
Artigo em Inglês | MEDLINE | ID: mdl-38330228

RESUMO

BACKGROUND & AIMS: The presence of metabolic dysfunction associated steatotic liver disease (MASLD) in patients with diabetes mellitus (DM) is associated with a high risk of cardiovascular disease, but is often under-diagnosed. The objective is to develop machine learning (ML) models for risk assessment of MASLD occurrence in patients with DM. METHODS: Feature selection determined the discriminative parameters, utilized to classify DM patients as those with and without MASLD. The multiple logistic regression (MLR) model's performance was quantified by sensitivity, specificity, percentage of correctly classified patients, and receiver operating characteristic (ROC) curve analysis. Decision curve analysis (DCA) assessed the model's net benefit for alternative treatments. RESULTS: We studied 2000 patients with DM (mean age 58.85±17.37 years; 48% women). Eight parameters: age, body mass index, type of DM, alanine aminotransferase, aspartate aminotransferase, platelet count, hyperuricaemia, and treatment with metformin were identified as discriminative. The experiments for 1735 patients show that 744/991 (75.08%) and 586/744 (78.76%) patients with/without MASLD were correctly identified (sensitivity/specificity: 0.75/0.79). The area under ROC (AUC) was 0.84 (95%CI: 0.82-0.86), while DCA showed a higher model's clinical utility, ranging from 30-84% threshold probability. Results for 265 test patients confirm the model's generalizability (sensitivity/specificity: 0.80/0.74, AUC: 0.81 [95%CI: 0.76-0.87]), whereas unsupervised clustering identified high-risk patients. CONCLUSIONS: A ML approach demonstrated high performance in identifying MASLD in patients with DM. This approach may facilitate better risk stratification and cardiovascular risk prevention strategies for high-risk patients with DM at risk of MASLD.

17.
Artigo em Inglês | MEDLINE | ID: mdl-37887693

RESUMO

(1) Background: We compared the impact of the COVID-19 pandemic on the functioning and mental health of chronically ill patients, namely those with hemodialysis (HD) and diabetes (DM). (2) Methods: We used a questionnaire to collect the medical data and the Generalized Anxiety Questionnaire (GAD-7) to measure the mood status. (3) Results: In both groups, a similar percentage of patients had a past COVID-19 infection and similar opinions about pandemic-related inconveniences. The most significant limitations of the study included mask wearing and the restriction of social contact. Mental disorders were significantly more frequently reported in the DM group. Sleep problems were found in approximately 30% of patients. Approximately 20% of patients in both groups declared that the pandemic had negatively affected the quality of their sleep. The mean score of the GAD-7 scale in the HD group did not differ according to gender. In the group of DM patients, a significant difference was observed between men and women, with women scoring higher compared to men. In both groups, the percentage of patients with GAD-7 scores > 5, > 10 and > 15 did not differ significantly. (4) Conclusions: In both groups, chronically ill patients reported anxiety disorders with similar frequency. In the DM group, more severe anxiety disorders were found in women. Mental disorders were significantly more prevalent in DM patients. It seems that HD patients coped better with the psychological aspects of pandemic-related stress and limitations.


Assuntos
COVID-19 , Pandemias , Masculino , Humanos , Feminino , COVID-19/epidemiologia , Transtornos de Ansiedade/epidemiologia , Ansiedade/epidemiologia , Doença Crônica , Atenção à Saúde , Depressão
18.
Adv Ther ; 40(8): 3395-3409, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37326901

RESUMO

iGlarLixi is a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide used in the treatment of type 2 diabetes. iGlarLixi has proven clinical benefits in terms of glycemia, weight control, and safety, defined by the risk of hypoglycemia. It simultaneously targets many pathophysiologic abnormalities which are at the root of type 2 diabetes and thus presents a complementary mode of action. Finally, it may also address diabetes treatment burden, and, by decreasing the complexity of treatment, it may improve patient adherence and persistence and fight against clinical inertia. This article reviews the results of major randomized controlled trials in people with type 2 diabetes that compared iGlarLixi to other therapeutic regimens, representing different intensification strategies, such as basal supported oral therapy, oral antidiabetic drugs, and a combination of the latter with glucagon-like peptide 1 receptor agonists. Moreover, as a supplement to randomized trials, data from real-world evidence have also been included.


Assuntos
Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glicemia , Hemoglobinas Glicadas , Combinação de Medicamentos , Insulina Glargina/uso terapêutico , Hipoglicemiantes/uso terapêutico
19.
JMIR Form Res ; 7: e46513, 2023 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-37247225

RESUMO

BACKGROUND: The transition period of patients with type 1 diabetes from pediatric to adult-oriented health care is associated with poorer glycemic control and less frequent clinic attendance. Fears and anxiety about the unknown, care approach differences in adult settings, and sadness about leaving the pediatric provider all contribute to a patient's reluctance to transition. OBJECTIVE: This study aimed to evaluate the psychological parameters of young patients with type 1 diabetes transitioning to an adult outpatient clinic during the first visit. METHODS: We examined 50 consecutive patients (n=28, 56% female) transitioning from March 2, 2021, to November 21, 2022, into adult care (3 diabetes centers from 3 regions in southern Poland: A, n=16; B, n=21; and C, n=13) and their basic demographic information. They completed the following psychological questionnaires: State-Trait Anxiety Inventory (STAI), Generalized Self-Efficacy Scale, Perceived Stress Scale, Satisfaction with Life Scale, Acceptance of Illness Scale, Multidimensional Health Locus of Control Scale Form C, Courtauld Emotional Control Scale, and Quality of Life Questionnaire Diabetes. We compared their data with those for the general healthy population and patients with diabetes from Polish Test Laboratory validation studies. RESULTS: During the first adult outpatient visit, patients' mean age was 19.2 (SD 1.4) years, with a diabetes duration of 9.8 (SD 4.3) years and BMI of 23.5 (SD 3.1) kg/m2. Patients came from diverse socioeconomic backgrounds: 36% (n=18) live in villages, 26% (n=13) live in towns with ≤100,000 inhabitants, and 38% (n=19) live in bigger cities. Regarding therapy type, 68% (n=34) were treated with insulin pump therapy, whereas 32% (n=16) were treated with multiple daily injections. Patients from center A had a mean glycated hemoglobin level of 7.5% (SD 1.2%). There was no difference regarding the level of life satisfaction, perceived level of stress, and state anxiety between the patients and reference populations. Patients had similar health locus of control and negative emotions control to the general population of patients with diabetes. Most patients (n=31, 62%) believe that control over their health depends on themselves, whereas 52% (n=26) believe that it depends mostly on others. Patients had higher levels of suppression of negative emotions-anger, depression, and anxiety-than the age-matched general population. Additionally, the patients were characterized by a higher acceptance of illness and higher level of self-efficacy compared to the reference populations: 64% (n=32) had a high level of self-efficacy and 26% (n=13) had a high level of life satisfaction. CONCLUSIONS: This study indicated that young patients transitioning to adult outpatient clinics have good psychological resources and coping mechanisms, which might result in adequate adaptation and adult life satisfaction including future metabolic control. These result also disprove the stereotypes that young people with chronic disease have worse life perspectives when entering adulthood.

20.
Endokrynol Pol ; 2023 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-37431873

RESUMO

There is increasing interest in sodium-glucose cotransporter 2 inhibitors (SGLT2i) as not only a new oral glucose-lowering drug class but also one with cardio- and nephroprotective potential. Understanding the underlying mechanisms is therefore of great interest, and postulated benefits have included increased natriuresis, lower blood pressure, increased haematocrit, enhanced cardiac fatty acid utilization, reduced low-grade inflammation, and decreased oxidative stress. In particular, redox homeostasis seems to be crucial in the pathogenesis of heart and kidney disease in diabetes, and there is accumulating evidence that SGLT2i have beneficial effects in this perspective. In this review, we aimed to summarize the potential mechanisms of the influence of SGLT2i on oxidative stress parameters in animal and human studies, with a special focus on heart failure and chronic kidney disease in diabetes mellitus.

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