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1.
Acta Diabetol ; 2020 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-32206903

RESUMO

AIMS: This study aimed to compare the efficacy and safety of generic exenatide with branded exenatide Byetta® in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues. METHODS: A multicenter, randomized, controlled, non-inferiority trial was performed. A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment. The primary endpoint was the change in HbA1c levels from baseline at week 16, with a non-inferiority margin of - 0.35% (- 3.83 mmol/mol) (lower bound of one-sided 95% confidence interval (CI) > - 0.35% (- 3.83 mmol/mol)). Secondary endpoints included the proportion of participants achieving HbA1c < 7% (53 mmol/mol), the changes in fasting plasma glucose (FPG), 2-h postprandial glucose (2hPG) following a standard meal, 7-point self-monitoring blood glucose (SMBG) profiles, body weight change from baseline at week 16 and the change in HbA1c levels from baseline at week 8. Safety issues were also evaluated. RESULTS: After 16 weeks of treatment, HbA1c levels decreased significantly from baseline in the two groups, with a reduction of - 1.10% ± 1.31% (- 12.0 mmol/mol ± 14.3 mmol/mol) in the generic exenatide group and - 1.08% ± 1.11% (- 11.8 mmol/mol ± 12.1 mmol/mol) in the branded exenatide group (both P < 0.001). The least-squares mean difference of HbA1c reduction between the two groups was - 0.03% (- 0.33 mmol/mol), with a lower one-sided 95% CI limit of - 0.27% (- 2.95 mmol/mol), which was higher than the prespecified non-inferiority margin of - 0.35% (- 3.83 mmol/mol). Moreover, there were no significant differences in the proportion of participants achieving HbA1c < 7% (53 mmol/mol) and the changes in FPG, 2hPG, 7-point SMBG profiles and body weight at week 16 and the change in HbA1c levels from baseline at week 8 (all P > 0.05) between the two groups. The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05). CONCLUSIONS: In patients with T2DM inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues, add-on treatment with generic exenatide demonstrated non-inferiority to branded exenatide in terms of improvements in HbA1c after 16 weeks of treatment. Furthermore, the two drugs were also similar for other efficacy endpoints and safety profile. Trial registration Chinese Clinical Trial Registry: ChiCTR-IPR-15006558, Date registered May 27, 2015.

2.
J Diabetes Complications ; 34(2): 107464, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31771933

RESUMO

AIMS: Our aim was to search for clinical predictors of good glycemic control in patients starting or intensifying oral hypoglycemic pharmacological therapy. METHODS: A multicenter, prospective cohort of 499 diabetic subjects was enrolled in this study: patients with newly diagnosed diabetes (NDM group) or poor glycemic control with oral antidiabetic drugs (OADs) (PDM group). All subjects then started or intensified OADs therapy and followed up for 91 days. Glycemic control was determined according to HbA1c at day 91 with HbA1c <7% considered good. RESULTS: The proportions of patients with good glycemic control after follow up for 91 days were 66.9% and 34.8% in NDM group and PDM group respectively. Logistic regression analysis showed that the change in GA at 28 days was the only predictor of good glycemic control in NDM patients (OR = 1.630, 95% CI 1.300-2.044, P < 0.001). In PDM patients, changes in GA at 28 days, CPI, baseline HbA1c, diabetic duration, and BMI were all independent predictors of good glycemic control (All P < 0.05). CONCLUSIONS: GA decline is a good predictor of future success in newly diagnosed patients. In patients intensifying therapy, beside GA decline, other individualized clinical characteristics should also be considered.

3.
Diabetes Ther ; 11(1): 247-257, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31823167

RESUMO

INTRODUCTION: The effect of dipeptidyl peptidase-4 (DDP-4) inhibitors versus α-glucosidase inhibitors (AGIs) on the treatment of type 2 diabetes mellitus (T2DM) in a real-world setting is unknown. The aim of this real-world study was to compare the glucose-lowering effect and tolerability of vildagliptin as add-on to metformin monotherapy (VM) and AGI as add-on to metformin monotherapy (AM) in Chinese patients with T2DM. METHODS: This was a subgroup analysis of the China Prospective Diabetes Study, a post-marketing, prospective, observational, real-world study conducted at 52 centers in China. T2DM patients with inadequate glycemic control on metformin monotherapy who received VM or AM were included. The composite primary endpoint was glycemic control (hemoglobin A1c [HbA1c] < 7%) after 12 months in the absence of tolerability events (hypoglycemia, weight gain ≥ 3%, or gastrointestinal events leading to treatment discontinuation). Propensity score matching (PSM) was used to balance the two groups. RESULTS: The success rates of the composite endpoint were higher in the VM group (n = 604/159 before/after PSM) than in the AM group (n = 159/157 before/after PSM), but the difference was not statistically significant (before PSM: 53.0 vs. 46.5%, P = 0.148; after PSM: 56.7 vs. 45.9%, P = 0.055). The glycemic control rate and HbA1c reduction were similar between groups at 3, 6, and 12 months. Compared with the AM group, the VM group had lower risks of any tolerability event (relative risk [RR] 0.53, 95% confidence interval [CI] 0.33-0.83, P = 0.006), of any adverse event (AE) (RR 0.64, 95% CI 0.41-1.00, P = 0.049), and of any serious AE (RR 0.45, 95% CI 0.25-0.81, P = 0.007). CONCLUSION: The results of this real-world study suggest that vildagliptin as add-on to metformin monotherapy had a similar glucose-lowering effect to AGI as add-on to metformin monotherapy, but with better safety.

4.
Front Neurosci ; 13: 1144, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31708736

RESUMO

Cardiovascular autonomic neuropathy (CAN) is a debilitating condition occurring among diabetic patients especially those with long duration of disease. Whereas incidences and treatment of CAN has been well described for Western populations, fewer studies have been conducted among the Chinese. This study, therefore, aimed to assess the prevalence of CAN among sampled Chinese diabetic patients. Accordingly, 2,048 participants with a history of type 1 diabetes mellitus (T1DM, 73) and type 2 diabetes mellitus (T2DM, 1975) were randomly sampled from 13 hospitals. Patients' biodata were recorded, and autonomic nervous system function tests performed to aid in the preliminary diagnosis of CAN. The final CAN diagnosis was based on the Ewing's test in which heart rate variation (HRV) values were evaluated through deep-breathing (DB), lying-to-standing (LS), and Valsalva (V) tests. Systolic blood pressure (SBP) variation values were also evaluated through LS. In the T1DM group, 61.6% patients were diagnosed with CAN and no differences were observed in the baseline and clinical data between this group and those without CAN (P > 0.05). In the T2DM group, 62.6% patients were diagnosed with CAN and statistically significant differences were found between the CAN and non- CAN group with regards to age, duration of diabetes, metformin treatment, retinopathy, and hypertension history (P < 0.05). The most common manifestations of CAN included weakness (28.6%), dizziness (23.4%), frequent urination (19.6%), upper body sweating (18.3%), and nocturia (15.9%). Additionally, duration of disease and age were independent risk factors for CAN in T1DM and T2DM, respectively. On diagnosis, a combination of the V test + LS test provided the highest sensitivity of detecting CAN among T1DM group (sensitivity = 97.6%, AUC = 0.887) while for T2DM category, DB test had the highest sensitivity (83.6%), and maximal AUC (0.856) was found with V test + DB test. The overall prevalence of diabetes with CAN in the study was up to 63%.

5.
Diabetes Ther ; 10(4): 1391-1405, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31222594

RESUMO

INTRODUCTION: The efficacy and safety of vildagliptin alone or with metformin is well established by randomized trials, but it is unknown whether it can be extrapolated to the real-world setting in Chinese patients with type 2 diabetes mellitus (T2DM). This study aimed to assess the effectiveness and safety of vildagliptin add-on to metformin versus dual oral antidiabetes drug (OAD), non-vildagliptin combination therapies in real-world Chinese patients with T2DM. METHODS: The China Prospective Diabetes Study was a post-marketing, prospective, multicenter, observational, real-world study conducted in 52 centers. Patients inadequately controlled with OAD monotherapy and who initiated vildagliptin add-on to metformin (VM cohort) or two OADs other than vildagliptin (comparator cohort) were included for the present analysis. The composite primary endpoint was glycated hemoglobin (HbA1c) < 7% and without tolerability events (hypoglycemia, weight gain ≥ 3%, or discontinuation due to gastrointestinal events) at 12 months. Secondary endpoints included change in HbA1c from baseline, subgroup analysis, and tolerability. Propensity score matching analysis was performed to adjust for baseline covariates imbalance (body mass index (BMI) and HbA1c). RESULTS: A total of 604 patients received VM and 670 received comparator therapy. Patients who received VM were younger, more obese, and had a higher baseline HbA1c and a shorter duration of T2DM. After propensity score matching, there were 530 patients per cohort. After 12-month treatment, the success rates of the composite primary endpoint were 50.9% and 33.0% in the VM and comparator cohorts, respectively (P < 0.001; odds ratio = 2.10, 95% confidence interval (CI) 1.64-2.70). Furthermore, the success rates of the composite endpoint were higher with VM across geographic area, BMI, and baseline HbA1c subgroups. Fewer tolerability events occurred in the VM cohort versus the comparator cohort (8.3% vs. 16.2%, P < 0.001; relative risk = 0.51, 95% CI 0.36-0.72). CONCLUSION: Compared with dual OAD non-vildagliptin combination therapies, vildagliptin add-on to metformin is effective and safe to achieve glycemic control in Chinese patients with T2DM. FUNDING: Novartis.

6.
Artigo em Inglês | MEDLINE | ID: mdl-30455667

RESUMO

Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes, and its progression significantly worsens the patient's quality of life. This study investigated the prevalence and risk factors associated with DPN in a large sample of Beijing individuals with type 1 and 2 diabetes, as well as compared the diagnostic methods for DPN. A total of 2,048 diabetic patients from 13 centers in Beijing were assessed for DPN through questionnaires and examination. Patients were divided into DPN group and suspected DPN/non-DPN group. The demographic, clinical and biological characteristics between the two groups were compared. Binary logistic regression analysis was performed to identify potential variables associated with DPN in diabetic patients. The diagnostic methods for DPN were also compared. Among the 2,048 diabetic patients, 73 cases of type 1 diabetes mellitus, 1,975 cases of type 2 diabetes were included in this study. Among them, 714 (34.86%) were identified with DPN, 537 (26.22%) were suspected of having DPN, and 797 (38.92%) were identified without DPN. Patient's age, duration of diabetes, and diabetic retinopathy were the significant independent risk factor for DPN among patients with type 2 diabetes. The odds ratio (OR) was 1.439 (95% confidence interval (CI): 1.282-1.616, P < 0.001), 1.297 (95% CI: 1.151-1.462, P < 0.001), and 0.637 (95% CI: 0.506-0.802, P < 0.001), respectively. Ankle reflex, temperature sensation plus vibration sensation are the best screening test for patients with type 1 and 2 diabetes. The Youden indexes were 62.2 and 69.8%, respectively. The prevalence rates of DPN in the Chinese patients with type 1 and type 2 diabetes in Beijing were 21.92 and 35.34%, respectively. Patient's age, duration of diabetes, and diabetic retinopathy are the independent risk factors for DPN.

7.
J Affect Disord ; 237: 80-86, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29793084

RESUMO

BACKGROUND: This study explores the prevalence of subthreshold depression (SubD) and its association with factors in type 2 diabetes mellitus (T2DM) patients. METHODS: This cross-sectional study involved 808 outpatients with T2DM from ten hospitals in Beijing between September 2015 and January 2016. All participants completed the Patient Health Questionnaire 9-item (PHQ-9) to evaluate depressive status, with scores between 5 and 14 considered SubD. Conditional logistic regression was conducted to investigate the variables associated with SubD in T2DM patients. RESULTS: T2DM patients with SubD comprised 11.6% (n = 94) of the sample. The odd ratios for the variables having significant positive associations with SubD were: being a women (OR = 1.90; 95%CI: 1.09-3.32), divorced/widowed (OR = 3.27; 95%CI: 1.46-7.30), comorbidity of cerebrovascular disease (OR = 2.00; 95%CI: 1.06-3.76), more diabetic complications (OR = 8.04; 95%CI: 2.77-23.31), and higher HbA1c in men (OR = 2.41; 95%CI: 1.25-4.64). Being older (OR = 0.78; 95%CI: 0.62-0.98), exercising more (OR = 0.44; 95%CI: 0.22-0.91) and poverty (OR = 0.36; 95%CI: 0.19-0.69) were negatively related to SubD. LIMITATIONS: The sample was mainly recruited from hospital settings, which limits generalization. The study's cross-sectional design precludes making causal inferences. CONCLUSIONS: The proportion of SubD was estimated to be 11.6% among T2DM patients in Beijing. Having more diabetic complications and being divorced/widowed made the odds of having SubD 8-fold and 3-fold higher than not having it, respectively. The relationship between SubD and diabetes necessitates early screening for milder forms of depression, which can alleviate the social burden and individual impairment from major depression or other chronic diseases.


Assuntos
Transtorno Depressivo/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Adolescente , Adulto , Idoso , Pequim/epidemiologia , Estudos Transversais , Transtorno Depressivo/diagnóstico , Diabetes Mellitus Tipo 2/diagnóstico , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Inquéritos e Questionários , Adulto Jovem
8.
J Diabetes ; 10(3): 256-265, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28727270

RESUMO

BACKGROUND: Limited information exists regarding the efficacy of pregabalin in Chinese patients with painful diabetic peripheral neuropathy (pDPN). METHODS: An 11-week double-blind placebo-controlled trial was performed in Chinese pDPN patients randomized (1 : 1) to 300 mg/day pregabalin or placebo. The primary outcome was change from baseline to endpoint in mean pain score (MPS; 0, no pain; 10, worst possible pain; using the mean of the last seven daily pain scores). Secondary outcomes included weekly MPS and responder status (MPS reduced by ≥30% or ≥50% vs baseline). Subgroup analysis assessed patients with severe (≥7) baseline MPS. Adverse events (AEs) were reported. RESULTS: In all, 620 patients were randomized (pregabalin, n = 313; placebo, n = 307). Improvement in MPS with pregabalin versus placebo was not significant (P = 0.0559). Post hoc sensitivity analyses, excluding one patient/site due to Good Clinical Practice (GCP) non-compliance, showed pregabalin significantly improved MPS when excluding the patient (P = 0.0448) or site (P = 0.0142). Pregabalin significantly improved weekly MPS (P = 0.0164) and ≥50% responders at endpoint (P = 0.0384). Improvement in proportion of ≥30% responders, impression of change, pain intensity, and sleep did not differ significantly between the treatment groups. In the severe pDPN subpopulation, pregabalin significantly improved MPS versus placebo (P = 0.0040). The most commonly reported AE was dizziness (9.6% vs 3.9% with placebo). CONCLUSIONS: Pregabalin did not significantly improve the primary measure of pain in the trial. Significant reductions in MPS were observed when excluding the GCP non-compliant patient/site and in the severe pDPN subpopulation. Pregabalin was well tolerated in Chinese pDPN patients.


Assuntos
Bloqueadores dos Canais de Cálcio/uso terapêutico , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Neuropatias Diabéticas/tratamento farmacológico , Pregabalina/uso terapêutico , Adolescente , Adulto , Idoso , Grupo com Ancestrais do Continente Asiático , Biomarcadores/metabolismo , Neuropatias Diabéticas/etiologia , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Segurança , Resultado do Tratamento , Adulto Jovem
9.
Diabetes Obes Metab ; 20(4): 1044-1049, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29144061

RESUMO

This prospective, multicentre, phase III study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5% to 10.5% and fasting plasma glucose (FPG) <15 mmol/L (270 mg/dL) on stable insulin therapy (20-150 U/d) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c. Saxagliptin treatment resulted in a greater adjusted mean change in HbA1c from baseline to week 24 than placebo (-0.58%; P < .001), irrespective of metformin use, and a greater mean change in FPG (0.9 mmol/L [-15.9 mg/dL]; P < .001). More patients achieved HbA1c <7% with saxagliptin (11.4%) than with placebo (3.5%, P = .002). Adverse events and incidence of hypoglycaemia were similar in both groups. Overall, add-on saxagliptin 5 mg once daily significantly improved glycaemic control without increasing hypoglycaemia risk and was well tolerated in Chinese patients with type 2 diabetes inadequately controlled by insulin (± metformin).


Assuntos
Adamantano/análogos & derivados , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Dipeptídeos/administração & dosagem , Insulina/administração & dosagem , Metformina/administração & dosagem , Adamantano/administração & dosagem , Adamantano/efeitos adversos , Adulto , Idoso , Grupo com Ancestrais do Continente Asiático , Glicemia/metabolismo , China , Diabetes Mellitus Tipo 2/sangue , Dipeptídeos/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada/efeitos adversos , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Insulina/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Placebos
10.
Diabetes Obes Metab ; 20(4): 1006-1013, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29227571

RESUMO

AIMS: Metformin treatment for type 2 diabetes mellitus (T2DM) can be limited by gastrointestinal (GI) adverse events (AEs), resulting in treatment discontinuation. We investigated whether once-daily metformin extended release (XR) is superior in terms of GI tolerability, with non-inferior efficacy, compared with thrice-daily metformin immediate release (IR) in treatment-naïve Chinese patients with T2DM. MATERIALS AND METHODS: This prospective, open-label, randomized, multicentre, phase IV interventional study enrolled Chinese T2DM patients to receive either metformin XR or metformin IR with a 2-week screening period, a 16-week treatment period and a 2-week follow-up period without treatment. Co-primary endpoints were a non-inferiority assessment of metformin XR vs metformin IR in glycated haemoglobin (HbA1c) least squares mean (LSM) change from baseline to week 16 and the superiority of GI tolerability for metformin XR vs metformin IR. RESULTS: Overall, 532 patients were randomized to metformin IR (n = 267) or metformin XR (n = 265). The HbA1c LSM change was -1.61% and -1.58% in each group, respectively (LSM difference, 0.03; 95% confidence interval [CI], -0.10, 0.17). Incidences of drug-related AEs were 26.5% (n = 66) in the metformin IR-only group and 32.2% (n = 85) in the metformin XR-only group, and GI AEs were 23.8% and 22.3% in each group, respectively (difference, -1.52; 95% CI, -8.60, 5.56). The treatment difference met the predefined non-inferiority upper CI margin of 0.4% in HbA1c. CONCLUSIONS: Metformin XR was non-inferior to metformin IR for the LSM change in HbA1c from baseline to week 16 and not superior to metformin IR for overall GI AE incidence during treatment of Chinese T2DM patients.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Metformina/administração & dosagem , Adulto , Idoso , Grupo com Ancestrais do Continente Asiático , China , Preparações de Ação Retardada , Diabetes Mellitus Tipo 2/sangue , Composição de Medicamentos , Feminino , Humanos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Resultado do Tratamento
11.
Mater Sci Eng C Mater Biol Appl ; 70(Pt 1): 628-636, 2017 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-27770936

RESUMO

In this paper, FeS nanoparticles anchored on reduced graphene oxide (rGO) nanosheets are synthesized via a facile direct-precipitation method. For the first time, a novel electrochemical sensor is developed based on FeS/rGO nanosheets modified glassy carbon electrode (GCE). It has been proved that the resultant FeS/rGO/GCE sensor is very suitable for the individual and simultaneous measurement of dopamine (DA) and acetaminophen (AC) and delivers excellent anti-interference ability to ascorbic acid (AA) and uric acid (UA). Under optimum conditions with differential pulse voltammetry method, a broad linear response versus the concentrations of DA and AC has been observed in the ranges of 2.0 to 250.0µM and 5.0 to 300.0µM, respectively. The detection limits for DA and AC are 0.098µM and 0.18µM, respectively. Furthermore, the as-obtained sensor has been successfully utilized in real samples and satisfactory results have been achieved. Consequently, by virtue of its outstanding electrocatalytic activity, excellent sensitivity, and long time stability, the as-obtained FeS/rGO modified electrode can be considered as a new promising DA and AC sensor.


Assuntos
Acetaminofen/sangue , Dopamina/sangue , Técnicas Eletroquímicas/métodos , Grafite/química , Nanocompostos/química , Tampões (Química) , Catálise , Eletrodos , Compostos Ferrosos/química , Vidro/química , Humanos , Concentração de Íons de Hidrogênio , Nanocompostos/ultraestrutura , Oxirredução , Padrões de Referência , Soluções
12.
Int J Mol Sci ; 17(9)2016 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-27608006

RESUMO

Diabetes mellitus (DM) is a common chronic medical problem worldwide; one of its complications is painful peripheral neuropathy, which can substantially erode quality of life and increase the cost of management. Despite its clinical importance, the pathogenesis of painful diabetic neuropathy (PDN) is complex and incompletely understood. Voltage-gated sodium channels (VGSCs) link many physiological processes to electrical activity by controlling action potentials in all types of excitable cells. Two isoforms of VGSCs, NaV1.3 and NaV1.7, which are encoded by the sodium voltage-gated channel alpha subunit 3 and 9 (Scn3A and Scn9A) genes, respectively, have been identified in both peripheral nociceptive neurons of dorsal root ganglion (DRG) and pancreatic islet cells. Recent advances in our understanding of tetrodotoxin-sensitive (TTX-S) sodium channels NaV1.3 and NaV1.7 lead to the rational doubt about the cause-effect relation between diabetes and painful neuropathy. In this review, we summarize the roles of NaV1.3 and NaV1.7 in islet cells and DRG neurons, discuss the link between DM and painful neuropathy, and present a model, which may provide a starting point for further studies aimed at identifying the mechanisms underlying diabetes and painful neuropathy.


Assuntos
Diabetes Mellitus/metabolismo , Neuropatias Diabéticas/metabolismo , Canal de Sódio Disparado por Voltagem NAV1.3/metabolismo , Canal de Sódio Disparado por Voltagem NAV1.7/metabolismo , Animais , Humanos , Ilhotas Pancreáticas/metabolismo , Bloqueadores dos Canais de Sódio/farmacologia , Tetrodotoxina/farmacologia
13.
J Diabetes Complications ; 30(8): 1609-1613, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27496253

RESUMO

AIMS: This study was to determine whether serum glycated albumin (GA) was a better indicator of glycemic control than hemoglobin A1c (HbA1c) when starting a new treatment regimen for type 2 diabetes. METHODS: Newly diagnosed type 2 diabetes patients, or patients who had poor glycemic control with oral hypoglycemic agents, were enrolled at 10 hospitals in Beijing. Serum GA, HbA1c, fasting blood glucose (FBG), and C-peptide were assayed on Days 0, 14, 28, and 91 after treatment. RESULTS: Four hundred ninety-nine patients were enrolled. Mean FBG, GA and HbA1c decreased significantly in patients at Days 14, 28, and 91. In patients with improved glycemic control, the reduction of GA and HbA1c levels was 10.5±13.3% vs. 5.1±5.4% on Day 14, 16.0±13.4% vs. 9.0±7.0% on Day 28, and 18.0±16.7% vs. 18.3±9.4% on Day 91, respectively, compared with baseline values. Changes in GA on Day 14, 28 and 91 were all closely correlated with changes in HbA1c on Day 91. Change in GA on Day 14 was correlated with treatment effectiveness evaluated by HbA1c on Day 91. CONCLUSIONS: GA may be a useful marker for assessing glycemic control at an early stage of new diabetes treatment and assist in guiding adjustments to treatment and therapy.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobina A Glicada/análise , Albumina Sérica/análise , Glicemia/análise , Diabetes Mellitus Tipo 2/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
14.
J Diabetes Investig ; 7(1): 85-93, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26816605

RESUMO

AIMS/INTRODUCTION: The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). MATERIALS AND METHODS: In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. RESULTS: Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively. CONCLUSIONS: Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.


Assuntos
Grupo com Ancestrais do Continente Asiático , Insulinas Bifásicas/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hipoglicemiantes/administração & dosagem , Insulina Aspart/administração & dosagem , Insulina Isófana/administração & dosagem , Insulina Regular Humana/administração & dosagem , Adulto , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , China/epidemiologia , Diabetes Mellitus Tipo 2/sangue , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisadores , Sujeitos da Pesquisa
15.
Int J Clin Exp Med ; 8(10): 19466-70, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26770593

RESUMO

OBJECTS: To examine how vascular endothelia (VE)-cadherin plasma levels are correlated with parameters associated with endothelial function such as endothelin-1, nitric oxide, nitric oxide synthase and HbA1c in type 2 diabetic patients with coronary artery disease. METHODS: VE-cadherin levels were analyzed by enzyme-linked immunosorbent assays. Spearman's correlation and multiple stepwise regression analyses were used to examine the relationship between plasma VE-cadherin and other factors. RESULTS: By univariate correlation analysis, plasma VE-cadherin levels were significantly associated with age, total cholesterol, triglyceride, hemoglobin A1c, and endothelin-1. Multiple regression analysis (adjusted for age, total cholesterol, and triglyceride) showed that plasma VE-cadherin levels were independently and significantly associated with HbA1c and ET-1. Plasma VE-cadherin levels were significantly highest in patients with diabetes mellitus and coronary artery disease. While patients with diabetes mellitus had higher levels of VE-cadherin compared with healthy subjects. CONCLUSIONS: This study found that VE-cadherin levels might be a biomarker for some endothelial dysfunction associated with coronary artery disease in type 2 diabetes mellitus.

16.
Anal Chem ; 85(16): 7738-44, 2013 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-23859117

RESUMO

In this article, a Venturi electrosonic spray ionization (V-ESSI) cataluminescence (CTL) sensor array was reported for discriminating saccharides in solution. Integrating electrosonic spray ionization (ESSI), a liquid system of Venturi self-pumping injection for the CTL reaction, was fabricated for enhancing CTL reactivity of aqueous samples. Comparing with simple Venturi injection by air and Venturi easy ambient sonic-spray ionization without electric assistance (V-EASI), the remarkable enhancement of CTL signals resulted from V-ESSI. This system showed higher cross-reactive CTL responses catalyzed by alkaline earth metal-nanomaterials than other catalysts, giving different signals for a given saccharide on different catalysts and different responses for different saccharides on the same catalyst. Then, a 4 × 2 CTL sensor array was used for obtaining "fingerprints" of distinct CTL response patterns. Analyzed by linear discriminant analysis (LDA), this V-ESSI CTL sensor array not only achieved the well discrimination of different saccharides (99.9% of total variation) but also discriminated four groups of urine sugar-level for urine samples from diabetic patients (98.1% of discrimination accuracy). It had good reproducibility and gave a linear range of 22.5-67558 µg/mL (R > 0.99) for xylose with a detection limit of 7.4 µg/mL on MgO. As a new artificial tongue, this system provided a simple, rapid, low cost, low energy consumption, and environmentally friendly pathway for aqueous sample discrimination. It has dramatically expanded applications of the CTL-based senor array and will be applicable to clinical diagnoses, environment monitoring, industrial controls, food industry, and various marine monitoring.


Assuntos
Carboidratos/análise , Luminescência , Espectrometria de Massas por Ionização por Electrospray/instrumentação , Estudos de Casos e Controles , Reações Cruzadas , Diabetes Mellitus/urina , Humanos
17.
PLoS One ; 8(2): e56703, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23460810

RESUMO

BACKGROUND: Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus. METHODS: In a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7-13 mmol/L and HbA1c 7-11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups - drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%. FINDINGS: In drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were -0.70% and -0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of -0.04% (-0.20, 0.12) in the drug naïve group, and those in metformin group were -0.45% and -0.59%, 0.14% (-0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group. INTERPRETATION: In patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide. TRIAL REGISTRATION: Chinese Clinical Trial Register number, ChiCTR-TRC-08000074.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Metformina/efeitos adversos , Metformina/uso terapêutico , Pessoa de Meia-Idade , Resultado do Tratamento
18.
Mater Sci Eng C Mater Biol Appl ; 33(1): 507-11, 2013 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-25428102

RESUMO

In this paper, nichrome was adopted as a substrate, to fabricate the pre-anodized inlaying ultrathin carbon paste electrode (PAIUCPE). The electrochemical behaviors of dopamine (DA) and epinephrine (EP) at the electrode were investigated by cyclic voltammetry (CV). The reaction mechanisms of DA and EP have also been put forward. It was found that the electrode showed an excellent electrochemical behavior for electrode reaction of DA and EP. The cathodic potential difference of DA and EP was about 370 mV and the simultaneous determination of DA and EP was achieved based on it. The reduction peak current was proportional to the DA and EP concentrations in the range of 8.0×10(-7)-3.0×10(-4) M and 2.0×10(-6)-1.5×10(-4) M with the detection limits of 1.70×10(-7) M and 3.27×10(-7) M, respectively. Because the oxidation of ascorbic acid (AA) is an irreversible reaction at the PAIUCPE, the interferences of AA for determining DA and EP were eliminated. The method has been successfully applied to the determination of DA and EP in hydrochloride injection with satisfactory results.


Assuntos
Carbono/química , Ligas de Cromo/química , Dopamina/química , Técnicas Eletroquímicas/métodos , Epinefrina/química , Eletricidade , Eletrodos , Concentração de Íons de Hidrogênio , Limite de Detecção , Reprodutibilidade dos Testes , Fatores de Tempo
19.
J Pediatr Endocrinol Metab ; 25(7-8): 711-6, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23155698

RESUMO

OBJECTIVE: To investigate the relationship between soluble intercellular adhesion molecule (sICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), monocytes chemotactic protein (MCP-1), von Willebrand factor (vWF), and coronary artery stenoses degree in coronary heart disease (CHD) within type 2 diabetes mellitus (T2DM) patients. METHODS: A total of 92 subjects were treated with coronary angiography (CAG), including 62 subjects with CHD. The individuals were divided into three groups, group A (32 patients with CHD and T2DM), group B (30 patients with CHD but no T2DM) and group C (30 patients with no CHD and T2DM). All patients were treated with a Gensini coronary angiography check. The correlations between sICAM-1, VCAM-1, MCP-1 and vWF in peripheral blood and coronary artery stenosis degree were analyzed. RESULTS: The average score of coronary artery stenosis degree was 30.75 +/-12.67 in group A, which was significantly higher than group B (11.20 +/-7.51) and group C (2.40 +/- 1.23) (p < 0.01). The mean levels of sICAM-1, VCAM-1, MCP-1 and vWF in serum showed that group A was significantly higher than group B and group C (p < 0.01), and also that group B was higher than group C. There were significant positive correlations between the degree of coronary artery stenosis and the mean level of sICAM-1, VCAM-1, MCP-1, vWF in group A (p < 0.01), but these were not shown in group B and group C (p > 0.05). CONCLUSIONS: Association analysis shown that the level of sICAM-1, VCAM-1, MCP-1 and vWF elevated in CHD with T2DM patients. Vascular endothelial dysfunction could be caused to the coronary artery stenosis pathophysiological process. Results from this study suggested that sICAM-1, VCAM-1, MCP-1 and vWF may contribute to the occurrence and development of vascular lesions in T2DM. These endothelial function related factors could be acceptable as a prediction and testing index of vascular complications in T2DM.


Assuntos
Doença das Coronárias/etiologia , Estenose Coronária/etiologia , Diabetes Mellitus Tipo 2/complicações , Cardiomiopatias Diabéticas/etiologia , Endotélio Vascular/fisiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Moléculas de Adesão Celular/sangue , Angiografia Coronária , Doença das Coronárias/sangue , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/fisiopatologia , Estenose Coronária/sangue , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/fisiologia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico por imagem , Diabetes Mellitus Tipo 2/fisiopatologia , Cardiomiopatias Diabéticas/sangue , Cardiomiopatias Diabéticas/diagnóstico por imagem , Cardiomiopatias Diabéticas/fisiopatologia , Progressão da Doença , Endotélio Vascular/diagnóstico por imagem , Endotélio Vascular/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Índice de Gravidade de Doença
20.
J Geriatr Cardiol ; 9(3): 228-36, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23097651

RESUMO

OBJECTIVES: To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. METHODS: In this open-label study, patients aged 40-75 years were randomized to receive conventional therapy alone, or with Cilostazol 100 mg bid, or with Probucol 250 mg bid, or with both in combination. Endpoints included changes in plasma biomarker and safety at 12 weeks. RESULTS: Of the 200 randomized patients, 165 for per-protocol and 160 for the safety (QTc intervals) were set, respectively. Probucol significantly reduced total cholesterol (P < 0.001), low-density lipoprotein cholesterol (LDL-C), (P = 0.01), and high-density lipoprotein cholesterol (HDL-C) (P < 0.001) compared with conventional therapy. Cilostazol was effective in increasing HDL-C (P = 0.002) and reducing triglycerides levels (P < 0.01) compared with conventional therapy. A trend towards significance was observed for the difference between conventional therapy alone and Probucol plus Cilostazol group for the change in oxidized low-density lipoprotein (Ox-LDL, P = 0.065). No significant effects on the majority of the remaining biomarkers were found across the treatment groups. CONCLUSIONS: We have confirmed that Ox-LDL could be a possible plasma atherosclerotic biomarker among the evaluated biomarkers, which reflected the synergetic effect of Cilostazol plus Probucol in patients with T2DM and ASO shown previously in preclinical studies.

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