Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.197
Filtrar
1.
Medicine (Baltimore) ; 99(1): e18553, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31895796

RESUMO

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a chronic disease that is increasing the number of cases worldwide. The treatments currently used have not worked as expected. Alternative and complementary medicines were inserted in health services, especially in primary care, as an attempt to minimize risks and help control diseases such as diabetes. Among the herbal medicines used stands out cinnamon, which can serve as an adjuvant in the control of diabetes. OBJECTIVE: To analyze the effectiveness of 3 grams of cinnamon (Cinnamomum verum) per day for 90 days in reducing glycemic and lipid levels in adults with T2DM compared with placebo METHODS:: A randomized, double-blind, placebo-controlled, phase II trial, which will be conducted at basic health units in the city of Parnaíba, state of Piauí, Brazil. In total, 130 people diagnosed with T2DM, followed at health units, with hemoglobin A1c > 6.5%, and using oral antidiabetic medicines, are expected to participate in the study. The intervention will last for 3 months, and each participant will receive a total of 3 bottles containing 120 capsules in each bottle of cinnamon or placebo. Each person should take 4 capsules daily, for 90 days. The patients will be distributed into the 2 groups by performing block randomization (n = 6) at a ratio of 1:1 according to a code generated by a software. Assessments of socioeconomic, clinical, lifestyle, anthropometric, and laboratory variables will be performed in 2 separate visits. DISCUSSION: This study will be the first to investigate cinnamon to reduce glycemic, lipid, and anthropometric levels in Brazil. In case of favorable results, this therapy may be used as an alternative or additional medicine in cases where only oral antidiabetic agents are used and can promote the use of the product to minimize future complications of patients with diabetes and people who do not have the disease. TRIAL REGISTRATION: RBR-2KKB6D, registered on December 11th, 2018.


Assuntos
Glicemia/efeitos dos fármacos , Cinnamomum zeylanicum , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Lipídeos/sangue , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos Fase II como Assunto , Diabetes Mellitus Tipo 2/sangue , Método Duplo-Cego , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
2.
Diabetes Res Clin Pract ; 157: 107867, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31568801

RESUMO

AIM: To evaluate the efficacy, safety and cost-effectiveness of ipragliflozin as an add-on therapy in patients with type 2 diabetes mellitus (T2DM). METHODS: PubMed, EMBASE, the Cochrane Library, Web of Science and four Chinese databases, as well as the ClinicalTrials.gov website were searched from their inception through Jan 2019. Methodological quality was assessed using the Cochrane risk of bias, and meta-analysis was performed using RevMan5.3. RESULTS: A total of 11 randomized controlled trials with 1766 patients were included. Ipragliflozin administered (50 mg) once daily as an add-on therapy to other glucose-lowering medications (metformin, pioglitazone, sulfonylurea, α-glucosidase inhibitor, sitagliptin, insulin) was associated with reductions in hemoglobin A1c (HbA1c) of -0.74% (95% confidence interval (CI) -1.00 to -0.48), fasting plasma glucose (WMD -25.03 mg/dL; 95% CI -32.89 to -17.16), weight, waist circumference, blood pressure, and triglycerides levels. Neither the incidence of treatment-emergent adverse events (TEAEs) (RR 1.08; 95% CI 1.00 to 1.16) nor drug-related TEAEs (RR 1.19; 95% CI 0.93 to 1.54) was significantly increased. However, it was associated with an increased risk of hypoglycemia when added to insulin (RR 1.71; 95% CI 1.13 to 2.61). Compared with the pioglitazone group and the sitagliptin + metformin group, the incremental cost-effectiveness ratio of ipragliflozin add-on therapy group was $4976.89, $2089.76 per percentage of qualified HbA1c, respectively. CONCLUSION: Ipragliflozin as an add-on therapy is well tolerated and effective. Ipragliflozin as an add-on therapy do not appear cost-effective compared with metformin alone, but may be competitive against pioglitazone group and the sitagliptin + metformin group.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Quimioterapia Combinada/métodos , Farmacoeconomia/normas , Glucosídeos/uso terapêutico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Tiofenos/uso terapêutico , Feminino , Glucosídeos/farmacologia , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Hipoglicemiantes/farmacologia , Masculino , Metformina/farmacologia , Pessoa de Meia-Idade , Inibidores do Transportador 2 de Sódio-Glicose/farmacologia , Tiofenos/farmacologia
3.
Endocr Regul ; 53(3): 187-190, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31517629

RESUMO

OBJECTIVE: While dulaglutide has been approved inpatients with type 2 diabetes (T2DM) in combination with insulin, it has not been studied in insulin-deficient patients, not whether they have type 1 diabetes (T1DM) or T2DM. The aim of this study is to assess the efficacy and safety of dulaglutide 0.75 mg/once weekly (QW) in patients with absolute insulin deficiency (n=10). SUBJECTS AND RESULTS: Significant reductions of HbA1c (9.30±1.03% to 8.61±1.21%; p<0.02) and body mass index (BMI; 23.61±3.95 to 23.41±4.24; p<0.02) levels were observed at 3 months with the addition of dulaglutide to the existing pharmacotherapy. However, in all the patients, post-meal C-peptide levels remained undetectable. One patient had gastrointestinal adverse events and discontinue dulaglutide within the first month. One patient was a non-responder, who had little if any changes in HbA1c levels at 3 months. CONCLUSIONS: The results indicate that dulaglutide is effective in patients with T1DM or T2DM with absolute insulin deficiency, though gastrointestinal adverse events might be of concern. The improvements in glycemic control could not be due to enhanced insulin secretion, but may be as a result of a combination of the other effects of glucagon like peptide 1 (GLP-1), such as postprandial glucagon suppression, delayed gastric emptying, and weight loss.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Fragmentos Fc das Imunoglobulinas/efeitos adversos , Insulina/deficiência , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/efeitos adversos , Idoso , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Esquema de Medicação , Quimioterapia Combinada , Feminino , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Insulina/administração & dosagem , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
4.
Nutrients ; 11(8)2019 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-31398841

RESUMO

Published evidence exploring the effects of dietary resistant starch (RS) on human cardiometabolic health is inconsistent. This review aimed to investigate the effect of dietary RS type 2 (RS2) supplementation on body weight, satiety ratings, fasting plasma glucose, glycated hemoglobin (HbA1c), insulin resistance and lipid levels in healthy individuals and those with overweight/obesity, the metabolic syndrome (MetS), prediabetes or type 2 diabetes mellitus (T2DM). Five electronic databases were searched for randomized controlled trials (RCTs) published in English between 1982 and 2018, with trials eligible for inclusion if they reported RCTs involving humans where at least one group consumed ≥ 8 g of RS2 per day and measured body weight, satiety, glucose and/or lipid metabolic outcomes. Twenty-two RCTs involving 670 participants were included. Meta-analyses indicated that RS2 supplementation significantly reduced serum triacylglycerol concentrations (mean difference (MD) = -0.10 mmol/L; 95% CI -0.19, -0.01, P = 0.03) in healthy individuals (n = 269) and reduced body weight (MD = -1.29 kg; 95% CI -2.40, -0.17, P = 0.02) in people with T2DM (n = 90). However, these outcomes were heavily influenced by positive results from a small number of individual studies which contradicted the conclusions of the majority of trials. RS2 had no effects on any other metabolic outcomes. All studies ranged from 1-12 weeks in duration and contained small sample sizes (10-60 participants), and most had an unclear risk of bias. Short-term RS2 supplementation in humans is of limited cardiometabolic benefit.


Assuntos
Diabetes Mellitus Tipo 2/sangue , Carboidratos da Dieta/farmacologia , Suplementos Nutricionais , Sobrepeso/sangue , Amido/farmacologia , Adulto , Glicemia/efeitos dos fármacos , Peso Corporal/efeitos dos fármacos , Jejum/sangue , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Resistência à Insulina , Lipídeos/sangue , Masculino , Síndrome Metabólica/sangue , Pessoa de Meia-Idade , Obesidade/sangue , Estado Pré-Diabético/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Resposta de Saciedade/efeitos dos fármacos
5.
Molecules ; 24(17)2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31466303

RESUMO

This study was designed to evaluate the effects of purple potato extract of the Blue Congo variety (PP) on diabetes and its antioxidant activities after two-week administration tostreptozotocin (STZ)-induced diabetic rats. The activities of PP were evaluated at a dose of 165 mg/kg body weight (b.w.) by estimating biochemical changes in blood plasma and through a histopathological study of kidney, muscles, and liver tissue. We evaluated the effect of treatment with extract on glucose level, glycated hemoglobin, activities of enzymatic antioxidants (including superoxide dismutase, glutathione peroxidase, and catalase), and lipid peroxidation. Moreover, we determined advanced glycation end-products (AGEs), advanced oxidation protein products (AOPPs), and the level of oxidative modified proteins (OMPs) as markers of carbonyl-oxidative stress in rats with diabetes. Using high-performance liquid chromatography, we identified five anthocyanins and six phenolic acids in the extract from Blue Congo with the dominant acylated anthocyanin as petunidin-3-p-coumaroyl-rutinoside-5-glucoside. The administration of Blue Congo extract lowered blood glucose, improved glucose tolerance, and decreased the amount of glycated hemoglobin. Furthermore, PP demonstrated an antioxidative effect, suppressed malondialdehyde levels, and restored antioxidant enzyme activities in diabetic rats. After administration of PP, we also noticed inhibition of OMP, AGE, and AOPP formation in the rats' blood plasma.


Assuntos
Antioxidantes/administração & dosagem , Diabetes Mellitus Experimental/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Extratos Vegetais/administração & dosagem , Solanum tuberosum/química , Animais , Antocianinas/administração & dosagem , Antocianinas/química , Antocianinas/farmacologia , Antioxidantes/química , Antioxidantes/farmacologia , Glicemia/análise , Glicemia/efeitos dos fármacos , Cromatografia Líquida de Alta Pressão , Diabetes Mellitus Experimental/sangue , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Hidroxibenzoatos/administração & dosagem , Hidroxibenzoatos/química , Hidroxibenzoatos/farmacologia , Hipoglicemiantes/química , Hipoglicemiantes/farmacologia , Masculino , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Ratos , Ratos Wistar , Estreptozocina
6.
Medicine (Baltimore) ; 98(33): e16850, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415414

RESUMO

BACKGROUND: Type 1 Diabetes Mellitus (T1DM) has long required insulin treatment. Sotagliflflozin (SOTA), as a dual SGLT-1/2 inhibitor, has the potential to be the first oral antidiabetic drug (OAD) to be approved for T1DM in the US market. It is important to evaluate the effectiveness of SOTA for T1DM. METHODS: Web of Science, PubMed datebase, Cochrane Library, Embase, Clinical Trials, and CNKI will be searched to identify randomized controlled trials (RCTs) exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluation will be performed on the obtained literature independently by 2 researchers; outcome indexes will be extracted. The bias risk of the included studies will be evaluated based on Cochrane assessment tool. Meta-analysis will be performed on the data using Revman 5.3 software. RESULT: We will provide practical and targeted results assessing the efficacy and safety of SOTA for T1DM patients, to provide reference for clinical use of SOTA. CONCLUSION: The stronger evidence about the efficacy and safety of SOTA for T1DM patients will be provided for clinicians. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019133099.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Glicosídeos/administração & dosagem , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Administração Oral , Terapia Combinada , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisão Sistemática como Assunto
7.
Endocr J ; 66(8): 745-752, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31308304

RESUMO

To examine the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) or once-daily second-generation basal insulin analogs (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes in routine clinical practice. A 12-week multicenter, open-label, randomized, pilot study was performed in 52 subjects with type 2 diabetes treated with oral antidiabetic drugs (OADs). Subjects were randomized to once-daily IDegAsp (n = 26) or basal insulin (n = 26). The primary endpoint was percent change in HbA1c from baseline to week 12. Furthermore, it was analyzed post hoc in subgroups stratified by baseline HbA1c. During a follow-up period, percent change in HbA1c was not significantly different between the two groups (p = 0.161). Daily insulin doses and frequency of overall hypoglycemia were also similar in the two groups. In post hoc analyses, once-daily basal insulin was more effective than IDegAsp in subjects with HbA1c more than or equal to 8.5% (p < 0.05); however, in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant improvement in percent change in HbA1c at week 12, compared with basal insulin (p < 0.01). Although there was no apparent difference in the HbA1c-lowering effects between two groups, when compared in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant effect in comparison with once-daily basal insulin. These findings suggest that the baseline HbA1c level might provide the important information for choosing IDegAsp or basal insulin in patients insufficiently controlled with OADs. This trial was registered with UMIN (no. UMIN000035431).


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina Glargina/administração & dosagem , Insulina Glargina/efeitos adversos , Insulina de Ação Prolongada/administração & dosagem , Insulina de Ação Prolongada/efeitos adversos , Administração Oral , Adulto , Idoso , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Preparações de Ação Retardada , Diabetes Mellitus Tipo 2/sangue , Relação Dose-Resposta a Droga , Esquema de Medicação , Combinação de Medicamentos , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Projetos Piloto
8.
BMJ Case Rep ; 12(6)2019 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-31243025

RESUMO

A female child with deafness was diagnosed to have neonatal diabetes mellitus at the age of 6 months, on routine evaluation prior to cochlear implant surgery. She presented to us at 11 months of age with diabetic ketoacidosis due to an intercurrent febrile illness. Her haematological parameters showed megaloblastic anaemia and thrombocytopenia. Therefore a possibility of Thiamine Responsive Megaloblastic Anaemia (TRMA) syndrome was considered. She was empirically treated with parenteral thiamine hydrochloride (Hcl). Subsequently, due to the unavailability of pharmacological preparation of oral thiamine Hcl in a recommended dose she was treated with benfotiamine. She had a sustained improvement in all her haematological parameters on oral benfotiamine. The insulin requirement progressively reduced and she is currently in remission for last 2 years. The genetic analysis confirmed the diagnosis of TRMA syndrome. Thus benfotiamine can be considered a new treatment option in management of TRMA syndrome.


Assuntos
Anemia Megaloblástica/tratamento farmacológico , Diabetes Mellitus/tratamento farmacológico , Perda Auditiva Neurossensorial/tratamento farmacológico , Deficiência de Tiamina/congênito , Tiamina/análogos & derivados , Administração Oral , Anemia Megaloblástica/complicações , Anemia Megaloblástica/diagnóstico , Diabetes Mellitus/diagnóstico , Cetoacidose Diabética/etiologia , Feminino , Mutação da Fase de Leitura , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Perda Auditiva Neurossensorial/complicações , Perda Auditiva Neurossensorial/diagnóstico , Humanos , Tiamina/administração & dosagem , Tiamina/farmacologia , Deficiência de Tiamina/complicações , Deficiência de Tiamina/diagnóstico , Deficiência de Tiamina/tratamento farmacológico , Resultado do Tratamento
9.
Afr Health Sci ; 19(1): 1594-1601, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31148988

RESUMO

Background: Herbal medicines long have been used in the management of diabetes mellitus (DM). Objective: This study was conducted to ascertain if fenugreek compared with glibenclamide had any impacts on controlling blood glucose in patients with uncontrolled type II DM on conventional therapy. Methods: A total of 12 patients with uncontrolled DM and on metformin were recruited and divided into two groups. Patients in group 1 received 2 g fenugreek per day, whereas those in group 2 received glibenclamide 5 mg once daily. The impacts of fenugreek on the glycemic control and lipid profile were measured before initiation of the regimen and then after 12 weeks. Results: Only 9 of the 12 study participants completed the study. Fenugreek at 2 g/day caused an insignificant drop in fasting blood glucose (P = 0.63), but the fasting insulin level increased significantly (P = 0.04). The ratio of high- to low-density lipoprotein was significantly decreased from before to after treatment (P = 0.006). Fenugreek did not cause any notable adverse impacts on hepatic and renal functions throughout the study. Conclusion: Fenugreek could be used as adjuvant therapy to anti-diabetic drugs to control blood glucose, and further studies are needed.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glibureto/química , Hemoglobina A Glicada/efeitos dos fármacos , Lipídeos/sangue , Extratos Vegetais/farmacologia , Extratos Vegetais/uso terapêutico , Trigonella/química , Adulto , Idoso , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/diagnóstico , Relação Dose-Resposta a Droga , Feminino , Humanos , Hipoglicemiantes/farmacologia , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Fitoterapia/métodos , Extratos Vegetais/química , Sementes , Resultado do Tratamento
10.
Phytother Res ; 33(6): 1616-1626, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30950136

RESUMO

BACKGROUND AND OBJECTIVES: The impetus for the current study was to evaluate the efficacy of propolis supplementation on markers of glycemic status in adults with type 2 diabetes mellitus (T2DM). METHODS: A comprehensive search was conducted in PubMed, Scopus, Cochrane Library, Web of Science, and Google Scholar up to August 2018, identifying randomized controlled trials investigating the effect of propolis supplementation on glycemic markers in adults with T2DM. Cochrane Collaboration tool was used to evaluate the risk of bias assessment. A random-effects model was applied in the meta-analysis to compensate for potential heterogeneity among the included studies. RESULTS: Six randomized controlled trials comprising 373 participants were included in the systematic review and meta-analysis. The results of the meta-analysis revealed significant reductions in fasting plasma glucose (-13.51 mg/dl; 95% CI [-24.98, -2.04]) and hemoglobin A1C (-0.52%; 95% CI [-0.94, -0.10]) concentrations following propolis supplementation. However, no significant lowering effect was observed in fasting insulin levels (-0.53 pmol/L; 95% CI [-1.69, 0.63]) or homeostasis model assessment of insulin resistance (-0.543; 95% CI [-1.72, 0.64]). CONCLUSION: This systematic review and meta-analysis suggested that propolis supplementation may be effective in controlling glycemic levels for T2DM patients. Further studies are needed to confirm these results.


Assuntos
Biomarcadores/sangue , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Própole/uso terapêutico , Adulto , Biomarcadores/análise , Glicemia/análise , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/epidemiologia , Jejum/sangue , Feminino , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Resistência à Insulina/fisiologia , Masculino
11.
PLoS One ; 14(4): e0215840, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31013312

RESUMO

SCOPE: Studies have demonstrated inconsistent effects of curcumin on glycemic outcomes and lipid parameters in patients with prediabetes and type 2 diabetes mellitus (T2DM). This study aimed to assess the effect of curcumin on glycemic control and lipid profile in prediabetes and T2DM. METHODS AND RESULTS: A systematic search of randomized controlled trials (RCTs) was conducted from inception to June 2018 in electronic sources including AMED, ANZCTR, BioMed Central, CENTRAL, CINAHL, ClinicalTrials.gov, Expanded Academic Index, Google Scholar, ISRCTN, LILACS, MEDLINE, NCCIH, Science Direct, Scopus, Web of Science, and WHO ICTRP. Hand search was also performed. Of the total 486 records, four trials (N = 508) and eight trials (N = 646) were eligible for the meta-analysis of individuals with prediabetes and T2DM, respectively. Curcumin significantly reduced glycosylated hemoglobin (HbA1c) in prediabetics (MD: -0.9%, 95% CI: -1.7 to -0.1%, p = 0.03). Furthermore, T2DM subjects gained favorable reduction in both HbA1c (MD: -0.5%, 95% CI: -1.0 to -0.0%, p = 0.04) and fasting plasma glucose (MD: -11.7 mg/dL, 95% CI: -22.1 to -1.3 mg/dL, p = 0.03). Tendency of lipid profile improvement was also observed. CONCLUSION: Our findings may encourage curcumin supplementation based on its meaningful effect on glycemic control and positive trend on lipid outcomes in prediabetes and T2DM.


Assuntos
Curcumina/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Lipídeos/sangue , Estado Pré-Diabético/tratamento farmacológico , Glicemia/efeitos dos fármacos , Colesterol/sangue , Diabetes Mellitus Tipo 2/sangue , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Estado Pré-Diabético/sangue
12.
J Med Econ ; 22(8): 806-813, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31010349

RESUMO

Aims: Several glucagon like peptide-1 (GLP-1) receptor agonists are available as weekly injections for treatment of type 2 diabetes. These medications vary in their injection devices, and these differences could impact quality-of-life and patient preference. The purpose of this study was to examine patient preferences and estimate health state utilities associated with injection devices for two weekly GLP-1 therapies. Materials and methods: Participants with type 2 diabetes in Italy (Milan, Rome) valued three health state vignettes in time trade-off interviews. The health states had identical descriptions of type 2 diabetes, but differed in description of the treatment process: (1) oral treatment regimen, (2) oral plus weekly dulaglutide injection, and (3) oral plus weekly semaglutide injection. Results: A total of 216 participants completed interviews (57.9% male; mean age = 60.5). Almost all patients (99.5%) preferred the oral health state over either injection health state. Comparing between the two injections, 88.4% preferred the dulaglutide health state, while 11.6% preferred the semaglutide state. Mean (SD) utilities were 0.907 (0.076) for oral, 0.894 (0.085) for dulaglutide, and 0.887 (0.087) for semaglutide. The mean (SD) utility difference between the injection device health states was 0.007 (0.019). Limitations: Although the health states were designed to match the injection device instructions for use as closely as possible, vignette-based methods are inherently limited because results are based on perceptions of the health states rather than actual patient experience with the devices. Conclusions: Results provide insight into patient preferences associated with injection devices for weekly GLP-1 receptor agonists. The majority of patients preferred the dulaglutide device over the semaglutide device, and for some patients, this difference had an impact on utility valuations. Patient preferences for injection devices could be an important factor to consider when selecting treatments for type 2 diabetes.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Hipoglicemiantes/uso terapêutico , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Preferência do Paciente , Proteínas Recombinantes de Fusão/uso terapêutico , Administração Oral , Idoso , Glicemia/efeitos dos fármacos , Análise Custo-Benefício , Quimioterapia Combinada , Feminino , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Hipoglicemiantes/administração & dosagem , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Injeções Subcutâneas , Itália , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Proteínas Recombinantes de Fusão/administração & dosagem
13.
Diabetes Res Clin Pract ; 152: 125-134, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31004676

RESUMO

AIMS: Compare the efficacy and safety of albiglutide from a ready-to-use, single-dose, auto-injector system with the lyophilized product in patients with type 2 diabetes mellitus (T2DM). METHODS: In this phase 3 study, 308 patients between 18 and 80 years with T2DM and experiencing inadequate glycemic control on their current regimen of diet/exercise alone or in combination with metformin were randomized 1:1 to weekly injections for 26 weeks with an active albiglutide auto-injector and placebo lyophilized dual-chamber cartridge (DCC) pen injector (n = 154) or active albiglutide lyophilized DCC pen injector and placebo liquid auto-injector (n = 154). Participants received liquid or lyophilized albiglutide 30 mg for 4 weeks, and then 50 mg for the remaining 22 weeks. Change in HbA1c and fasting plasma glucose (FPG), pharmacokinetics, and safety were assessed. RESULTS: In the albiglutide liquid and lyophilized drug product groups, 55.6% (85/153) and 45.5% of patients (70/154) had a baseline HbA1c ≥ 8.0%, respectively. The model-adjusted least squares (LS) mean change in HbA1c from baseline at week 26 was -1.1% (95% CI: -1.3, -1.0) and -1.2% (95% CI: -1.3, -1.0; noninferiority P = 0.0002) in the albiglutide liquid and lyophilized product groups, respectively. Similarly, the model-adjusted LS mean change in FPG from baseline at week 26 in the albiglutide liquid and lyophilized product groups was -2.2 (95% CI: -2.6, -1.8) mmol/L and -1.9 (95% CI: -2.3, -1.5) mmol/L, respectively. No new safety concerns were identified. CONCLUSION: Change from baseline in HbA1c for albiglutide liquid was noninferior to lyophilized drug product in patients with T2DM.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeo 1 Semelhante ao Glucagon/análogos & derivados , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Composição de Medicamentos , Feminino , Liofilização , Peptídeo 1 Semelhante ao Glucagon/administração & dosagem , Peptídeo 1 Semelhante ao Glucagon/efeitos adversos , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/administração & dosagem , Metformina/efeitos adversos , Pessoa de Meia-Idade , Soluções , Resultado do Tratamento , Adulto Jovem
14.
Phytother Res ; 33(6): 1648-1657, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30942510

RESUMO

Diabetes mellitus is a metabolic disease that manifested as hyperglycemia due to the defect in secretion or function of insulin. Studies have shown that saffron and its derivatives cause a significant reduction in plasma glucose levels in experimental models. The purpose of this study was to investigate the effect of the saffron extract on fasting plasma glucose (FPG), glycated hemoglobin level (HbA1c), lipid profile, liver enzymes, and renal function tests in type 2 diabetic patients. In this double-blind randomized clinical trial, 64 type 2 diabetic patients who were on oral anti-diabetic drugs were examined. Participants received either 15 mg of saffron or placebo capsules (two pills per day) for 3 months. Anthropometric indices, dietary intake, FPG, HbA1c, lipid profiles, liver enzymes (ALT, AST, ALP), and renal function (BUN, Cr.) tests were measured pre and post intervention after 3 months. Independent t test and paired t test were used for data analysis. After 3-months intervention, mean difference of FPG, Cholesterol, LDL-c, and LDL/HDL ratio between two groups showed significant reduction(p < 0.0001), but HbA1c, HDL-C, API, TG showed no significant differences (p > 0.05). In saffron group, FPG, HbA1c, cholesterol, LDL-c, and LDL/HDL ratio decreased significantly after 3-months intervention compare with baseline (p < 0.0001).


Assuntos
Crocus/química , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/metabolismo , Rim/efeitos dos fármacos , Fígado/efeitos dos fármacos , Extratos Vegetais/uso terapêutico , Adulto , Idoso , Glicemia/análise , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/fisiopatologia , Método Duplo-Cego , Etanol/química , Jejum/sangue , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/sangue , Rim/fisiologia , Testes de Função Renal , Metabolismo dos Lipídeos/efeitos dos fármacos , Lipídeos/sangue , Fígado/metabolismo , Fígado/fisiologia , Testes de Função Hepática , Masculino , Pessoa de Meia-Idade , Extratos Vegetais/química , Água/química
15.
BMJ ; 365: l1328, 2019 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-30967375

RESUMO

OBJECTIVE: To assess the efficacy and safety of dual sodium glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin in type 1 diabetes mellitus. DESIGN: Meta-analysis of randomised controlled trials. DATA SOURCES: Medline; Cochrane Library; Embase; international meeting abstracts; international and national clinical trial registries; and websites of US, European, and Japanese regulatory authorities, up to 10 January 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials evaluating the effect of sotagliflozin versus active comparators or placebo on glycaemic and non-glycaemic outcomes and on adverse events in type 1 diabetes in participants older than 18. Three reviewers extracted data for study characteristics, outcomes of interest, and risk of bias and summarised strength of evidence using the grading of recommendations assessment, development, and evaluation approach. Main outcomes were pooled using random effects models. RESULTS: Of 739 records identified, six randomised placebo controlled trials (n=3238, duration 4-52 weeks) were included. Sotagliflozin reduced levels of glycated haemoglobin (HbA1c; weighted mean difference -0.34% (95% confidence interval -0.41% to -0.27%), P<0.001); fasting plasma glucose (-16.98 mg/dL, -22.1 to -11.9; 1 mg/dL=0.0555 mmol/L) and two hour-postprandial plasma glucose (-39.2 mg/dL, -50.4 to -28.1); and daily total, basal, and bolus insulin dose (-8.99%, -10.93% to -7.05%; -8.03%, -10.14% to -5.93%; -9.14%, -12.17% to -6.12%; respectively). Sotagliflozin improved time in range (weighted mean difference 9.73%, 6.66% to 12.81%) and other continuous glucose monitoring parameters, and reduced body weight (-3.54%, -3.98% to -3.09%), systolic blood pressure (-3.85 mm Hg, -4.76 to -2.93), and albuminuria (albumin:creatinine ratio -14.57 mg/g, -26.87 to -2.28). Sotagliflozin reduced hypoglycaemia (weighted mean difference -9.09 events per patient year, -13.82 to -4.36) and severe hypoglycaemia (relative risk 0.69, 0.49 to 0.98). However, the drug increased the risk of ketoacidosis (relative risk 3.93, 1.94 to 7.96), genital tract infections (3.12, 2.14 to 4.54), diarrhoea (1.50, 1.08 to 2.10), and volume depletion events (2.19, 1.10 to 4.36). Initial HbA1c and basal insulin dose adjustment were associated with the risk of diabetic ketoacidosis. A sotagliflozin dose of 400 mg/day was associated with a greater improvement in most glycaemic and non-glycaemic outcomes than the 200 mg/day dose, without increasing the risk of adverse events. The quality of evidence was high to moderate for most outcomes, but low for major adverse cardiovascular events and all cause death. The relatively short duration of trials prevented assessment of long term outcomes. CONCLUSIONS: In type 1 diabetes, sotagliflozin improves glycaemic and non-glycaemic outcomes and reduces hypoglycaemia rate and severe hypoglycaemia. The risk of diabetic ketoacidosis could be minimised by appropriate patient selection and down-titration of the basal insulin dose.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Glicosídeos/uso terapêutico , Hipoglicemia/prevenção & controle , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Glicemia/análise , Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/epidemiologia , Cetoacidose Diabética/induzido quimicamente , Cetoacidose Diabética/epidemiologia , Relação Dose-Resposta a Droga , Hemoglobina A Glicada/efeitos dos fármacos , Glicosídeos/administração & dosagem , Glicosídeos/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos
16.
Medicine (Baltimore) ; 98(14): e14970, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30946322

RESUMO

BACKGROUND: Conflicting evidence exists on the effect of vitamin D supplementation on glucose metabolism in subjects with type 2 diabetes (T2D). Therefore, this meta-analysis focuses on the relationship between vitamin D intervention and glycaemic control in subjects with T2D. METHODS: We reviewed available randomized controlled trials (RCTs) studies from the establishment time of each database to March 31, 2018. Stata 13.0 software was used to evaluate the included literature. RESULTS: Finally, a total of 19 RCT studies involving 747 intervention subjects and 627 placebo controls were included in this meta-analysis. Meta-analysis results showed that compared with the control group, the short-term vitamin D supplementation group had a decline in hemoglobin A1c (HbA1c), insulin resistance, and insulin. The Standard Mean Difference (SMD) (95% CI [95% confidence interval]) of HbA1c, insulin resistance, and insulin were -0.17 (-0.29, -0.05), -0.75 (-0.97, -0.53), -0.57 (-0.78, -0.35), respectively with all P value <.05. But there were no significant differences in long-term follow-up vitamin D intervention. CONCLUSION: Vitamin D supplementation in T2D patients can improve HbA1c, insulin resistance, and insulin in short-term intervention, suggesting that vitamin D can be considered as a therapeutic agent along with the other treatments for T2D.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Vitamina D/uso terapêutico , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Insulina/metabolismo , Resistência à Insulina/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Vitamina D/administração & dosagem , Vitaminas/uso terapêutico
17.
J Endocrinol Invest ; 42(10): 1165-1169, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30955180

RESUMO

PURPOSE: We did a meta-analysis with meta-regression to evaluate the relationship between hemoglobin A1c (A1C) reduction and the primary CV outcome of cardiovascular outcome trials (CVOTs). METHODS: We used a random effects meta-analysis of the 12 CVOTs to quantify the effect of A1C reduction on major cardiovascular events (MACE) risk by stratifying the difference in achieved A1C (drug vs placebo) in three strata: A1c < 0.3%, A1c ≥ 0.3% and < 0.5%, and A1c ≥ 0.5%. RESULTS: We found a relation between the reduction in achieved A1C and the hazard ratio reduction for MACE (P = 0.002), explaining almost all (94.1%) the between-study variances: lowering A1C by 0.5% conferred a significant HRR of 20% (95% CI 4-33%) for MACE. CONCLUSIONS: Blood glucose reduction may play a more important role than previously thought in reducing the risk of MACE during treatment with the newer glucose-lowering drugs, including peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors.


Assuntos
Sistema Cardiovascular/efeitos dos fármacos , Ensaios Clínicos como Assunto , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobina A Glicada/metabolismo , Hipoglicemiantes/uso terapêutico , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Doenças Cardiovasculares/induzido quimicamente , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Ensaios Clínicos como Assunto/métodos , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Angiopatias Diabéticas/sangue , Angiopatias Diabéticas/prevenção & controle , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Projetos de Pesquisa , Resultado do Tratamento
18.
Ann Agric Environ Med ; 26(1): 62-66, 2019 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-30922031

RESUMO

INTRODUCTION: Nicotine is an alkaloid that affects the functioning of the central nervous system and produces dependence. In low doses, it acts as a stimulant and relaxant. Nicotine was reported to have pro-cognitive effects in humans and animals. However, high doses of nicotine are harmful for many organs.The aim of the study was to check whether a 30-day exposure to transdermal nicotine affects memory and biochemical parameters in mice. MATERIAL AND METHODS: A total of 32 mice (16 males and 16 females) were used in the experiment. Mice were divided into 4 groups of 8 animals each: I control-females receiving placebo patches for 30 days, II females receiving nicotine patches for 30 days, III control-males receiving placebo patches, IV males receiving nicotine patches. Spontaneous alternation and locomotor activity were examined weekly in a Y-maze. Body mass was recorded daily. On day 30, venous blood samples were obtained and the animals were anaesthetized with CO2. Their blood was used to measure alanine transaminase (ALT), asparagine transaminase (AST), cholesterol, creatinine and glycosylated haemoglobin (HbA1C). RESULTS: Nicotine significantly improved memory in male mice on day 8. It increased ALT and AST activities in males and females, as well as the concentration of cholesterol in their blood sera. CONCLUSIONS: In conclusion, transdermal nicotine may produce transient improvement in fresh spatial memory in male mice, but it is not a long-term effect and therefore nicotine does not seem to be appropriate for use in the treatment of neurodegenerative disorders. It elevates blood cholesterol level and thus may increase the risk of atherosclerosis and cardiovascular events; moreover, it negatively affects liver enzymes. Nicotine use is therefore not recommended.


Assuntos
Nicotina/farmacologia , Memória Espacial/efeitos dos fármacos , Administração Cutânea , Alanina Transaminase/sangue , Animais , Peso Corporal , Colesterol/sangue , Creatinina/sangue , Feminino , Hemoglobina A Glicada/efeitos dos fármacos , Locomoção/efeitos dos fármacos , Masculino , Camundongos , Nicotina/administração & dosagem , Transaminases/sangue
20.
Metabolism ; 94: 39-46, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30653978

RESUMO

AIMS: Metformin and lifestyle intervention are frequently prescribed together as first-line treatments for type 2 diabetes. However, little is known about their interplay. We investigated if the effects of a lifestyle intervention on glycemia, body mass and cardiorespiratory fitness (CRF) were influenced by metformin therapy. METHODS: Participants randomized to intensive lifestyle intervention (ILI) or diabetes support and education (DSE) from the Look AHEAD trial were categorized into metformin therapy vs. no metformin. A two-by-two ANCOVA (i.e., metformin therapy vs. no metformin by ILI vs. DSE) was used to examine the changes in glycated hemoglobin A1C, fasting plasma glucose (FPG), body mass, and CRF over the first year post-randomization, with a primary interest in the metformin-by-lifestyle interaction effect. RESULTS: Data from 1982 participants were analyzed. There was a significant metformin-by-lifestyle interaction effect on A1C (p = 0.031) and FPG (p = 0.043), resulting from larger reductions associated with metformin therapy compared to no metformin following DSE, but slightly smaller reduction associated with metformin therapy compared to no metformin following ILI. Metformin therapy was associated with smaller weight loss (-4.7 ±â€¯6.2 vs. -5.7 ±â€¯6.3 kg; main effect: p = 0.001) but not with differential CRF changes when compared to no metformin. CONCLUSIONS: The interaction between metformin therapy and lifestyle intervention on glycemia highlights the complicated nature of combining therapies. While the small influence of background metformin therapy on intensive lifestyle intervention should not discourage the concomitant use of these therapies, our results showed that, for individuals undergoing intensive lifestyle therapy, background metformin therapy conferred little additional benefits.


Assuntos
Diabetes Mellitus Tipo 2/terapia , Estilo de Vida , Metformina/uso terapêutico , Glicemia/efeitos dos fármacos , Índice de Massa Corporal , Aptidão Cardiorrespiratória , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Resultado do Tratamento , Perda de Peso/efeitos dos fármacos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA