Diabetes, Endocrine and Metabolic Diseases
As far as concern research activities, the Unit performs both spontaneous and sponsored clinical trials, in collaboration with the Trial Office and the main five clinical areas of the Institute. The Unit has also activated collaborations with the Research Units of CCM to carry on studies managed by nurses and psychologists on the psycho-social aspects of diabetes.
An important collaboration has been started with the Department of Cardiovascular, Dysmetabolic and Aging Diseases of the Istituto Superiore di Sanità (ISS) focused on the study of diabetes, cardiovascular diseases and related risk factors. ISS and CCM will share the data collected by the Institutes on these topics, in particular the data from the CUORE Project, and carry out detailed statistical analyses for:
- evaluation of lifestyles aspects in diabetic patients, and association with other clinical and socio-economic risk conditions;
- assessment of the role of fasting glucose for the prediction of cardiovascular risk in the general population;
- implementation of nested case-control studies, using biological data and samples available from both parties for project proposals in public health setting;
- realization of common projects for the implementation of strategies to prevent diabetes and its complications, and more generally chronic diseases at the population level;
- activation of initiative services of primary prevention aiming to slow, and/or avoid, and/or postpone the disease in people with dysglycemia and pre-hypertension, improving lifestyles and in particular physical activity;
- dissemination of information on dysglycemia and diabetes and on the promotion of prevention through healthy lifestyles, indicated in the mission of the Department of Cardiovascular, Dysmetabolic and Aging Diseases of ISS.
Clinical Trials
Effects of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin on left ventricular myocardial dysfunction in patients with type 2 diabetes mellitus and concentric left ventricular geometry (DYDA2-trial)
The glucagon-like peptide-1 receptors (glucagon-like peptide-1, GLP-1) have been identified in the myocardium and in the endothelium and the hypothesis that they carry out anti-apoptotic protective effects has been advanced. Experimental data suggest that GLP-1, besides exercising the classic glucoregulatory actions, has direct effects on the cardiovascular system. These direct effects have characteristics of cardioprotection and vasodilation. Some preliminary human clinical studies seem to support an improvement in mechanical function following GLP-1 administration to patients with dysfunctional left ventricle. GLP-1 receptor agonists such as exenatide have been shown to reduce necrotic damage to post-ischemic reperfused myocardium.
To date, the information available on the effect of dipeptidyl peptidase-4 inhibitors (DPP-4) is poor, on the other hand the unexpected and unclearly increase in hospitalizations for heart failure in patients DDP-4 inhibitor saxagliptin, recently reported as part of the SAVOR TIMI study, requires extensive assessments in this field. In animal experiments (rat), a cardioprotective function of linagliptin has been demonstrated in the setting of acute myocardial infarction and uremic cardiomyopathy. Based on these observations, we propose the evaluation of the addition of linagliptin on left ventricular function in patients with type 2 diabetes mellitus (DMT2) adequately controlled with the usual therapy, as part of a randomized study, placebo-controlled, on subjects with concentric LV geometry, defined by a prior basic echocardiographic evaluation.
The aim of the study is to gather information on the efficacy and safety of linagliptin administered as adjunctive therapy to patients with DMT2 with asymptomatic LV systolic dysfunction.