Diabetology Unit

Ancona, Italy

Diabetology Unit

Ancona, Italy
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Monami M.,University of Florence | Nreu B.,University of Florence | Scatena A.,Diabetology Unit | Cresci B.,University of Florence | And 5 more authors.
Diabetes, Obesity and Metabolism | Year: 2017

Aim: Glucagon-like peptide 1 receptor agonists (GLP1-RA) have been associated with an increased risk of pancreatitis and pancreatic cancer. Prior meta-analyses of randomized controlled trials failed to show any significant increase of risk; however, those meta-analyses did not include the recently published cardiovascular outcome trials (CVOT) with GLP1-RA, which provide a substantial additional body of data. The aim of the present meta-analysis is to assess the effect of GLP1-RA on pancreatitis, pancreatic cancers and cholelithiasis. Materials and methods: A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide or semaglutide) was performed, collecting all randomized clinical trials with a duration >11 weeks, enrolling patients with type 2 diabetes and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. Results: Of the 113 trials fulfilling inclusion criteria, 13 did not report information on pancreatitis, whereas 72 reported no events in all treatment groups. The incidence of pancreatitis and pancreatic cancer with GLP1-RA was not significantly different from that observed in comparator arms (MH-OR [95% CI] 0.93 [0.65-1.34], P =.71, and 0.94 [0.52-1.70], P =.84, respectively), whereas, a significantly increased risk of cholelithiasis (MH-OR [95% CI] 1.30 [1.01-1.68], P =.041) was detected. Conclusions: Presently available data confirm the safety of GLP-1 receptor agonists for pancreatitis. Conversely, therapy with those drugs is associated with an increased risk of cholelithiasis, which deserves further investigation. © 2017 John Wiley & Sons Ltd


Dicembrini I.,University of Florence | Nreu B.,University of Florence | Scatena A.,Diabetology Unit | Andreozzi F.,University of Catanzaro | And 3 more authors.
Acta Diabetologica | Year: 2017

Aims: Results with GLP1-receptor agonists (GLP-1RA) on microvascular complications of diabetes are contrasting. In trials designed for cardiovascular outcomes, both liraglutide and semaglutide were associated with a relevant reduction in the incidence and progression of nephropathy. On the other hand, in the same trials, semaglutide was associated with an increased progression of retinopathy, and a similar trend was observed for liraglutide. This meta-analysis is aimed at assessing the effects of GLP-1RA on retinopathy and nephropathy.Methods: A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, or semaglutide) was performed, collecting all randomized clinical trials with a duration >11 weeks, enrolling patients with type 2 diabetes, and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. Results: Of the 113 trials fulfilling the inclusion criteria, 78 and 62 did not report information on retinopathy and nephropathy, respectively. Treatment with GLP1-RA was not associated with a significant increase in the incidence of retinopathy (MH-OR [95% CI] 0.92 [0.74–1.16]. p = 0.49). In subgroup analyses, GLP1-RA were associated with a lower risk of retinopathy in comparison with sulfonylureas. Cases of macular edema were reported only in nine trials with no sign of increased risk. GLP1-RA reduced the incidence of nephropathy with respect to comparators (MH-OR [95% CI] 0.74 [0.60–0.92]. p = 0.005). This difference was significant versus placebo, but not versus any class of active comparators. Conclusions: GLP1-RA appear to reduce the incidence and/or progression of nephropathy and to have no specific effect on retinopathy—with the notable exception of semaglutide, which could have a negative impact on the retina. © 2017 Springer-Verlag Italia S.r.l.


Modesti P.A.,University of Florence | Castellani S.,University of Florence | Calabrese M.,Diabetology Unit | Malandrino D.,University of Florence | Zhao D.,Capital Medical University
Diabetes Research and Clinical Practice | Year: 2017

Aims Type 2 diabetes (T2DM) is a recognized risk factor for intracranial stenosis (ICS) in China where ischemic stroke is a health priority. In Europe little information is available on T2DM prevalence among Chinese minority groups and vascular screening is commonly limited to extracranial vessels. Feasibility of community-based T2DM screening, differences in T2DM prevalence between Chinese migrants and Italians, and prevalence of ICS among Chinese patients with newly diagnosed T2DM were investigated. Methods Chinese first generation migrants (n = 1200) and native Italians (n = 291) aged 35–59 years were enrolled in a cross-sectional survey. Diagnosis of T2DM was based on fasting plasma glucose and/or current treatment with glucose-lowering drugs. Newly diagnosed Chinese patients were screened for ICS using Doppler ultrasound. Results T2DM was more prevalent among Chinese (n = 168, 14.0%) than Italians (n = 21, 7.3%) (age- and gender adjusted OR 2.29; 95% C.L. 1.41–3.72). Prevalence of ICS among newly diagnosed Chinese was 18.2%. Nine out of the 17 patients with any ICS (52%) had >1 intracranial lesion. Conclusions T2DM screening within the Chinese community was feasible revealing prevalence twice as much as in the Italian cohort; the 18% prevalence of ICS in newly diagnosed Chinese patients stresses the need of implementing appropriate vascular screening strategies. © 2017 Elsevier B.V.


Salvi F.,Italian National Research Centres On Aging Inrca | Marchetti A.,Italian National Research Centres On Aging Inrca | D'Angelo F.,Diabetology Unit | Boemi M.,Diabetology Unit | And 3 more authors.
Drug Safety | Year: 2012

Older adults are about four to seven times more likely than younger persons to experience adverse drug events (ADEs) that cause hospitalization, especially if they are women and take multiple medications. The prevalence of drug-related hospitalizations has been reported to be as high as 31%, with large heterogeneity between different studies, depending on study setting (all hospital admissions or only acute hospital admissions), study population (entire hospital, specific wards, selected population and/or age groups), type of drug-related problem measured (adverse drug reaction or ADE), method of data collection (chart review, spontaneous reporting or database research) and method and definition used to detect ADEs. The higher risk of drug-related hospitalizations in older adults is mainly caused by age-related pharmacokinetic and pharmacodynamic changes, a higher number of chronic conditions and polypharmacy, which is often associated with the use of potentially inappropriate drugs. Other factors that have been involved are errors related to prescription or administration of drugs, medication non-adherence and inadequate monitoring of pharmacological therapies.Afew commonly used drugs are responsible for the majority of emergency hospitalizations in older subjects, i.e. warfarin, oral antiplatelet agents, insulin and oral hypoglycaemic agents, central nervous system agents. The aims of the present review are to summarize recent evidence concerning drug-related hospitalization in older adults, to assess the contribution of specific medications, and to identify potential interventions able to reduce the occurrence of these drug-related events, as they are, at least partly, potentially preventable. Adis © 2012 Springer International Publishing AG. All rights reserved.


Vaccaro O.,University of Naples Federico II | Franzini L.,University of Parma | Miccoli R.,University of Pisa | Cavalot F.,University of Turin | And 7 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-To evaluate the feasibility and effectiveness of an intensive, multifactorial cardiovascular risk reduction intervention in a clinic-based setting. RESEARCH DESIGN AND METHODS-The study was a pragmatic, cluster randomized trial,with the diabetes clinic as the unit of randomization. Clinics were randomly assigned to either continue their usual care (n = 5) or to apply an intensive intervention aimed at the optimal control of cardiovascular disease (CVD) risk factors and hyperglycemia (n = 4). To account for clustering, mixed model regression techniques were used to compare differences in CVD risk factors and HbA1c. Analyses were performed both by intent to treat and as treated per protocol. RESULTS-Nine clinics completed the study; 1,461 patients with type 2 diabetes and no previous cardiovascular events were enrolled. After 2 years, participants in the interventional group had significantly lower BMI, HbA1c, LDL cholesterol, and triglyceride levels and significantly higher HDL cholesterol level than did the usual care group. The proportion of patients reaching the treatment goals was systematically higher in the interventional clinics (35%vs. 24% for LDL cholesterol, P = 0.1299; 93% vs. 82% for HDL cholesterol, P = 0.0005; 80% vs. 64% for triglycerides, P = 0.0002; 39% vs. 22% for HbA1c, P = 0.0259; 13%vs. 5%for blood pressure, P = 0.1638). The analysis as treated per protocol confirmed these findings, showing larger and always significant differences between the study arms for all targets. CONCLUSIONS-A multifactorial intensive intervention in type 2 diabetes is feasible and effective in clinical practice and it is associated with significant and durable improvement in HbA1c and CVD risk profile. © 2013 by the American Diabetes Association.


Monesi L.,Irccs Instituto Of Ricerche Farmacologiche Mario Negri | Tettamanti M.,Irccs Instituto Of Ricerche Farmacologiche Mario Negri | Cortesi L.,Irccs Instituto Of Ricerche Farmacologiche Mario Negri | Baviera M.,Irccs Instituto Of Ricerche Farmacologiche Mario Negri | And 11 more authors.
Nutrition, Metabolism and Cardiovascular Diseases | Year: 2014

Aims: To investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes. Methods and results: We examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of Lombardy followed from 2002 to 2007. Age and sex-adjusted rates were calculated and hazard ratios (HR) were estimated with a matched population without diabetes of the same sex, age (±1 year) and general practitioner.There were 158,426 patients with newly diagnosed diabetes and 314,115 subjects without diabetes. Mean follow-up was 33.0 months (SD ± 17.5). 9.7% of patients with diabetes were hospitalized for cardiovascular events vs. 5.4% of subjects without diabetes; mortality rate was higher in patients with diabetes (7.7% vs. 4.4%). The estimated probability of hospitalization during the follow up was higher in patients with diabetes than in subjects without for coronary heart disease (HR 1.4, 95% CI 1.3-1.4), cerebrovascular disease (HR 1.3.95% CI 1.2-1.3), heart failure (HR 1.4, 95% CI 1.3-1.4) as was mortality (HR 1.4, 95% CI 1.4-1.4).Younger patients with diabetes had a risk of death or hospital admission for cardio-cerebrovascular events similar to subjects without diabetes ten years older. Conclusions: The elevated morbidity and mortality risks were clear since the onset of diabetes and rose over time. These data highlight the importance of prompt and comprehensive patients care in addition to anti-diabetic therapy in patients with newly diagnosed diabetes. © 2013 Elsevier B.V.


PubMed | Diabetology Unit and Clemente Estable Biologic Research Institute IIBCE
Type: Journal Article | Journal: Journal of pediatric genetics | Year: 2016

The concept of a new form of diabetes, with signs of both types 1 and 2, has not been often considered, until recently. It is of immense interest to explore the role of the admixture that characterizes the Uruguayan population (higher and different from other Latin America countries) for the presence of such expression of that particular disease. We describe here a child who possibly presents with this expression. He had typical signs of both diabetic conditions: type 1 (young age, positive immunologic and genetic markers, ketoacidosis) and type 2 (obesity [body mass index = 36 kg/m(2)] and acanthosis nigricans). In spite of complying with the established guidelines, therapeutic and nutritional control, quality of life and good metabolic control, the patients obesity had been continually increasing. Looking for a genetic explanation, we studied three single nucleotide polymorphisms involved in three different metabolic pathways (peroxisome proliferator-activated receptor gamma 2, insulin receptor substrate-1 and uncoupling protein-2) associated with insulin resistance. Our patient showed three mutations, GG, GA, GG, associated with insulin resistance that explains obesity associated with limited response to the commonly used drugs. According to the clinical presentation and the genetic and immunological background, we considered that this patient presents with a new form of diabetes. We have termed this particular disease hybrid diabetes because of the involvement of genes associated with both the classical type of diabetes. However, at least in an admixed population such as in Uruguay, clinical classification would not strictly dictate the choice of treatment.


PubMed | Diabetology Unit, Irccs Instituto Of Ricerche Farmacologiche Mario Negri and Regional Health Ministry
Type: | Journal: Nutrition, metabolism, and cardiovascular diseases : NMCD | Year: 2016

In contrast to the well-documented global prevalence of diabetes, much less is known about the epidemiology of cardiovascular (CV) complications in recent years. We describe the incidence of major CV events, deaths and drug prescribing patterns from 2002 to 2012 in subjects with (DM) or without diabetes mellitus (No DM).Subjects and outcomes were identified using linkable health administrative databases of Lombardy, a region in Northern Italy. A logistic regression model was used to compare myocardial infarction (MI), stroke, major amputation and death between DM and No DM in 2002 and 2012 and between the two index years in each population. The interaction between years and diabetes was introduced in the model. From 2002 to 2012 the incidence of major CV complications and death fell in both groups with a larger reduction among DM only for CV events: OR (95% CI) for the interaction 0.86 (0.79-0.93) for MI, 0.89 (0.82-0.96) for stroke, 0.78 (0.57-1.06) for major amputations. CV prevention drugs rose considerably from 2002 to 2012 particularly in DM and a switch towards safer antihyperglycemic drugs was also observed.Major CV complications and death declined from 2002 to 2012 in both DM and No DM. This might be due to a larger increase in prescriptions of CV drugs in DM and a relevant change toward recommended antihyperglycemic drugs.


Culeddu N.,CNR Institute of Biomolecular Chemistry | Chessa M.,Sardinian Mediterranean Imaging Research Group | Porcu M.C.,CNR Institute of Biomolecular Chemistry | Fresu P.,University of Sassari | And 3 more authors.
Metabolomics | Year: 2012

The genetic homogeneity of the people of Sardinia makes it an ideal place to study genetic related diseases such as type 1 diabetes, which in this island has one of the highest incidence worldwide. The principal objective of this study was to use 1H high-resolution NMR spectroscopy and supervised methods of multivariate data analysis to highlight the importance of the variation of low concentration metabolites between healthy and diabetic Sardinian children. To achieve this goal, statistical analyses were performed after removal of the prevailing signals of sugars and citrate (related to carbohydrate metabolism) and of hippurate (a metabolite of bacterial origins) whose presence overwhelmed all the other compounds effects on classification. The variable influence in the statistical model showed that other metabolites deriving from gut microbial metabolism (p-cresol sulphate and phenylacetylglycine) were heavily involved in classification. This suggests the importance of changes in gut microbiota composition associated with type 1 diabetes in children. © 2012 Springer Science+Business Media, LLC.


PubMed | University of Verona, Diabetology Unit, Azienda Ospedaliera Spedali Civili di Brescia and University of Brescia
Type: | Journal: Scientific reports | Year: 2015

To evaluate the effects of supervised exercise training (SET) on cardiometabolic risk, cardiorespiratory fitness and oxidative stress status in 2 diabetes mellitus (T2DM), twenty male subjects with T2DM were randomly assigned to an intervention group, which performed SET in a hospital-based setting, and to a control group. SET consisted of a 12-month supervised aerobic, resistance and flexibility training. A reference group of ten healthy male subjects was also recruited for baseline evaluation only. Participants underwent medical examination, biochemical analyses and cardiopulmonary exercise testing. Oxidative stress markers (1-palmitoyl-2-[5-oxovaleroyl]-sn-glycero-3-phosphorylcholine [POVPC]; 1-palmitoyl-2-glutaroyl-sn-glycero-3-phosphorylcholine [PGPC]) were measured in plasma and in peripheral blood mononuclear cells. All investigations were carried out at baseline and after 12 months. SET yielded a significant modification (p < 0.05) in the following parameters: VOmax (+14.4%), gas exchange threshold (+23.4%), waist circumference (-1.4%), total cholesterol (-14.6%), LDL cholesterol (-20.2%), fasting insulinemia (-48.5%), HOMA-IR (-52.5%), plasma POVPC (-27.9%) and PGPC (-31.6%). After 12 months, the control group presented a VOmax and a gas exchange threshold significantly lower than the intervention group. Plasma POVC and PGPC were significantly different from healthy subjects before the intervention, but not after. In conclusion, SET was effective in improving cardiorespiratory fitness, cardiometabolic risk and oxidative stress status in T2DM.

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