Rationale, Design, and Methods of the Study of Comparison of Canagliflozin vs. Teneligliptin Against Basic Metabolic Risks in Patients with Type 2 Diabetes Mellitus (CANTABILE study): Protocol for a Randomized, Parallel-Group Comparison Trial

AbstractBackgroundDipeptidyl peptidase-4 (DPP-4) inhibitors and sodium-glucose co-transporter 2 (SGLT2) inhibitors are widely used antidiabetic drugs. However, to date, no studies have directly compared the effects of these two drugs on the components of the metabolic syndrome in patients with type 2 diabetes mellitus (T2DM).ObjectivesThe Comparison of Canagliflozin vs. Teneligliptin against Basic Metabolic Risks in Patients with T2DM (CANTABILE) study aims to examine whether the DPP-4 inhibitor (teneligliptin) or the SGLT2 inhibitor (canagliflozin) is the more effective drug for reducing metabolic risk factors as a composite in Japanese patients with T2DM.MethodsThe CANTABILE study is a prospective, multicenter, open-label, randomized, parallel-group comparison study. A total of 200 patients with T2DM treated with metformin alone or without glucose-lowering agents will be enrolled if they have one or more of the metabolic risk factors, such as obesity, borderline high blood pressure, and dyslipidemia. They will then will be randomized into the Teneligliptin group or the Canagliflozin group and treated for 24  weeks. The primary endpoint is the composite ratio of subjects with one or more improved metabolic risk factors. The secondary endpoints are the changes in each component of the primary endpoint.Planned outcomesThe CANTABILE study provides valuable evidence to indicate the suitability of SGLT2 inhibitors or DPP-4 inhibitors for Japanese patients with T2DM and metab...
Source: Diabetes Therapy - Category: Endocrinology Source Type: research

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AbstractCardiovascular diseases (CVD) are one of the leading causes of death worldwide. Testosterone (T) is an important sex hormone that triggers several genomic and non-genomic pathways, leading to improvements of several cardiovascular risk factors and quality of life in men. At the vascular level, the key effect of T is the vasorelaxation. This review discusses the molecular pathways and clinical implications of T in the vascular system. Firstly, the mechanisms involved in the T vasodilator effect will be presented. Then, it will be discussed the association of T with the main risks for CVD, namely metabolic syndrome, ...
Source: Journal of Cardiovascular Translational Research - Category: Cardiology Source Type: research
The metabolic syndrome (MetS), characterized by a group of cardiovascular disease (CVD) risk factors including truncal obesity, hypertension, deranged lipid profiles, and abnormal glucose metabolism [1], is a significant risk factor for CVD and type 2 diabetes mellitus (T2DM) [2]. The prevalence of obesity in South Africa is exceptionally high, at 11% in men and 41% in women [3], compared to that of the USA, where 31.7% of men and 33.9% of women are obese [4]. The prevalence of MetS in South Africa is increasing due to the high prevalence of obesity and poor dietary habits, which are now also reported in rural areas [5, 6].
Source: Prostaglandins, Leukotrienes and Essential Fatty Acids - Category: Biomedical Science Authors: Source Type: research
AbstractBackgroundSingle anastomosis sleeve ileal (SASI) bypass is a newly introduced bariatric and metabolic procedure. The present multicenter study aimed to evaluate the efficacy of the SASI bypass in the treatment of patients with morbid obesity and the metabolic syndrome.MethodsThis is a retrospective, seven-country, multicenter study on patients with morbid obesity who underwent the SASI bypass. Data regarding patients ’ demographics, body mass index (BMI), percentage of total weight loss (%TWL), percentage of excess weight loss (%EWL), and improvement in comorbidities at 12 months postoperatively and postopera...
Source: Obesity Surgery - Category: Surgery Source Type: research
Publication date: Available online 23 October 2019Source: The Journal of Steroid Biochemistry and Molecular BiologyAuthor(s): Margarida Lorigo, Melissa Mariana, Manuel C. Lemos, Elisa CairraoAbstractTestosterone (T) is the predominant endogenous androgen in the bloodstream. At the vascular level, T presents genomic and non-genomic effects, and both effects may overlap. The genomic actions assume that androgens can freely cross the plasma membrane of target cells and bind to nuclear androgen receptors, inducing gene transcription and protein synthesis. The non-genomic effects have a more rapid onset and may be related to th...
Source: The Journal of Steroid Biochemistry and Molecular Biology - Category: Biochemistry Source Type: research
Authors: Andreeva-Gateva PA, Mihaleva ID, Dimova II Abstract Diabetes mellitus and cardiovascular diseases are part of the metabolic syndrome and share similar risk factors, including obesity, arterial hypertension, and dyslipidemia. Atherosclerosis and insulin resistance contribute to the development of the diseases, and subclinical inflammation is observed in both conditions. There are many proofs about the connection between epigenetic factors and different diseases, including diabetes and cardiovascular diseases. Interestingly, recent studies show that at least some anti-diabetic drugs, as well as blockers of t...
Source: Postgraduate Medicine - Category: Internal Medicine Tags: Postgrad Med Source Type: research
The Metabolic Syndrome may be tentatively defined as the clustering of several metabolic risk factors in the same individual. A progressively higher number of children and adolescents is affected by this syndrome worldwide, mainly as a consequence of the constant increase of the prevalence of obesity and sedentary habits. As obesity, the chance that the metabolic syndrome traks into adulthood is high. Moreover, the evidence of an association between the duration of the exposition to metabolic risk factors and morbidity and mortality justifies early treatment and prevention of the metabolic syndrome in both children and ado...
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
Authors: Gao RY, Hsu BG, Wu DA, Hou JS, Chen MC Abstract Background: Fibroblast growth factor 21 (FGF21) acts as a potent metabolic regulator. Serum FGF21 levels were significantly higher in obesity and type 2 diabetes mellitus (T2DM) populations. The aim of this study was to evaluate the relationship between serum FGF21 levels and metabolic syndrome (MetS) in T2DM patients. Methods: Fasting blood samples were obtained from 126 T2DM patients. MetS and its components were defined according to the diagnostic criteria from the International Diabetes Federation. Serum FGF21 concentrations were measured using a comm...
Source: International Journal of Endocrinology - Category: Endocrinology Tags: Int J Endocrinol Source Type: research
This article reviews the literature on CAN in obesity, pre-DM and MetS, to help determine a rationale for screening, early intervention treatment and formulate future resear ch questions in this highly prevalent condition.
Source: Diabetes Therapy - Category: Endocrinology Source Type: research
Non-alcoholic fatty liver disease (NAFLD) is a growing challenge to global public health. It is defined as the increased accumulation of hepatic triglyceride (>5%) in the absence of excessive alcohol consumption or other causes of liver disease. The NAFLD spectrum encompasses steatosis (non-alcoholic fatty liver, NAFL) and non-alcoholic steatohepatitis (NASH), an inflammatory form of the condition marked by the presence of hepatocyte damage and progressive fibrosis that may lead to cirrhosis.[1,2] Although NAFLD may occur in patients with normal weight, it is closely associated with the presence of the metabolic syndrom...
Source: Journal of Hepatology - Category: Gastroenterology Authors: Source Type: research
In a society where physical activity is limited and food supply is abundant, metabolic diseases are becoming a serious epidemic. Metabolic syndrome (MetS) represents a cluster of metabolically related symptoms such as obesity, hypertension, dyslipidemia, and carbohydrate intolerance, and significantly increases type 2 diabetes mellitus risk. Insulin resistance and hyperinsulinemia are consistent characteristics of MetS, but which of these features is the initiating insult is still widely debated. Regardless, both of these conditions trigger adverse responses from the pancreatic β cell, which is responsible for produci...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
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