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In type 2 diabetes (T2D), several differences have been described between men and women, concerning risk factors, clinical manifestations and chronic complications. The impact of gender on the efficacy and safety of hypoglycaemic drugs is still to be clarified. Some data suggest that GLP1-RAs may have greater efficacy on body weight in women, but comparable efficacy on glycaemic control and cardiovascular risk (CVD) in both sexes. The aim of our study was to evaluate in real-life clinical practice the possible influence of gender on the effectiveness and safety of GLP1-RAs long-acting therapy in T2D outpatients. In this single-centre observational study, we evaluated laboratory parameters, chronic complications, hypoglycaemic episodes, and any adverse events of subjects with T2D who started treatment with GLP1-RAs long-acting between 1 June 2018 and 31 May 2019, in add on to metformin or other hypoglycaemic drugs, and who practiced this therapy for at least two years. In the present analysis, 391 subjects with T2D were included (men 59.3%, women 40.7%), with a mean age of 64.1 years and mean duration of diabetes of 18.4 years. At baseline, patients were on average obese (BMI 32.8 kg/m2) with an inadequate glycaemic control (HbA1c 7.8%). Women had higher BMI values than men; glycaemic control was similar in both genders. After two years of follow-up, therapy with GLP1-RAs long-acting determined a significant reduction of BMI and blood pressure values, HbA1c, fasting glucose and GPT levels and an improvement in lipid profile. The reduction observed in BMI values was significantly greater in T2D women than in men. At stepwise regression analysis, female gender was among the independent predictors of the effectiveness of GLP1-RAs in terms of BMI reduction, together with fasting blood glucose, but not in terms of reduction of HbA1c levels, which was significantly associated with baseline blood glucose levels and metformin use, irrespective of gender. Overall, the treatment with GLP1-RAs was well tolerated, and only mild gastro-intestinal adverse events were observed (n=22; 5.6%, 14 men and 12 women P0.05), in both genders. In conclusion, in real-life clinical practice, the therapy with GLP1-RAs long-acting is safe and effective in both men and women, and it seems to be associated with a more beneficial effect on body weight in women than in men.

Summary: Background: Despite the overall improvement in care, people with type 2 diabetes (T2D) experience an excess risk of end-stage kidney disease. We evaluated the long-term effectiveness of dapagliflozin on kidney function and albuminuria in patients with T2D. Methods: We included patients with T2D who initiated dapagliflozin or comparators from 2015 to 2020. Propensity score matching (PSM) was performed to balance the two groups. The primary endpoint was the change in estimated glomerular filtration rate (eGFR) from baseline to the end of observation. Secondary endpoints included changes in albuminuria and loss of kidney function. Findings: We analysed two matched groups of 6197 patients each. The comparator group included DPP-4 inhibitors (40%), GLP-1RA (22.3%), sulphonylureas (16.1%), pioglitazone (8%), metformin (5.8%), or acarbose (4%). Only 6.4% had baseline eGFR 30 mg/g. During a mean follow-up of 2.5 year, eGFR declined significantly less in the dapagliflozin vs comparator group by 1.81 ml/min/1.73 m2 (95% C.I. from 1.13 to 2.48; p

Dysphagia is any disorder of the swallowing process. It can be classified according to the disordered phase of swallowing: oral dysphagia, pharyngeal dysphagia, esophageal dysphagia. Approximately 1% of children in the general population will experience swallowing difficulties, although the incidence is much higher in some clinical populations. Although oropharyngeal dysphagia may be the first symptom of a neuromuscular disorder, gastroesophageal reflux disease (GERD), functional esophageal disorders, and eosinophilic esophagitis are the most common causes of esophageal dysphagia. Treatment and management of dysphagia must be tailored to the clinical characteristics of the individual patient.

Abstract Aims To examine the association of the screening frequency of estimated glomerular filtration rate (eGFR) with the substantial reduction in eGFR (≥ 25%) among type 2 diabetes (T2D) patients with normal (eGFR≥60 ml/min/1.73 m2) and impaired kidney function (eGFR

Summary: Background: A delay in reaching HbA1c targets in patients with newly-diagnosed type 2 diabetes (T2D) is associated with an increased long-term risk of developing cardiovascular diseases (CVD), a phenomenon referred to as legacy effect. Whether an early introduction of glucose-lowering drugs with proven benefit on CVD can attenuate this phenomenon is unknown. Methods: Using data derived from a large Italian clinical registry, i.e. the AMD Annals, we identified 251,339 subjects with newly-diagnosed T2D and without CVD at baseline. Through Cox regressions adjusted for multiple risk factors, we examined the association between having a mean HbA1c between 7.1 and 8% or >8%, compared with ≤7%, for various periods of early exposure (0–1, 0–2, 0–3 years) and the development of later (mean subsequent follow-up 4.6 ± 2.9 years) CVD, evaluated as a composite of myocardial infarction, stroke, coronary or peripheral revascularization, and coronary or peripheral bypass. We performed this analysis in the overall cohort and then splitting the population in two groups of patients: those that introduced sodium-glucose transport protein 2 inhibitors (SGLT-2i) during the exposure phase and those not treated with these drugs. Findings: Considering the whole cohort, subjects with both a mean HbA1c between 7.1 and 8% and >8%, compared with patients attaining a mean HbA1c ≤ 7%, showed an increased risk of developing the outcome in all the three early exposure periods assessed, with the highest risk observed in patients with mean HbA1c > 8% in the 3 years exposure period (hazard ratio [HR]1.33; 95% confidence interval [CI] 1.063–1.365). The introduction of SGLT-2i during the exposure periods of 0–1 and 0–2 years eliminated the association between poor glycemic control and the outcome (p for interaction 0.006 and 0.003, respectively, vs. patients with the same degree of glycemic control but not treated with these drugs). Interpretation: Among patients with newly diagnosed T2D and free of CVD at baseline, a poor glycemic control in the first three years after diagnosis is associated with an increased subsequent risk of CVD. This association is no longer evident when SGLT-2i are introduced in the first two years, suggesting that these drugs attenuate the phenomenon of legacy effect. An early treatment with these drugs might thus promote a long-lasting benefit in patients not attaining proper glycemic control after T2D diagnosis. Funding: This work was supported, in part, by the Italian Ministry of Health (Ricerca Corrente) to IRCCS MultiMedica.

Considering other pharmacological approaches, also in the field of insulin therapy, the use of biosimilar drugs instead of originators could help to reduce the worldwide increasing costs of its related disease, that is, diabetes mellitus (DM), and the subsequent risk of insulin underutilization. Available evidences clearly demonstrate that biosimilar efficacy and safety are superimposable to those of the originator insulin with lower expenditure; despite this, however, their underutilization persists both in Eastern and in Western countries. Specific, regional activities are needed in order to improve biosimilar insulin use and to contribute to a substantial reduction of the costs of DM.

Nutcracker syndrome (NCS) is a rare pediatric disease caused by left kidney vein compression. Besides the “Triade’s symptoms”, including hematuria, proteinuria, and flank pain, a wide spectrum of clinical manifestations has been reported. As the significant hemodynamic changes secondary to the dilatation of the left renal vein, serious consequences such as renal vein thrombosis and severe anemia might occur in these children. NCS diagnosis includes a variety of invasive and non-invasive imaging tools, but cutoff values need to be further validated. A conservative treatment represents the most common therapeutic approach for these patients, but operative options are available in selected cases. To complicate matters, a standard diagnostic and treatment algorithm is currently lacking and scientific pediatric evidence in this field is still poor and limited. In this perspective, early recognition of NCS is crucial but challenging for pediatricians. Therefore, a better knowledge of the disease is recommended. Starting from two different clinical presentations of NCS, we aimed to provide a comprehensive overview of the disease in children.

Abstract Background We described, in a large sample of patients with type 1 diabetes mellitus (T1DM) and GFR ≤ 60 mL/min/1.73 m2 (with or without albuminuria), the differences in the clinical features associated with the two different chronic kidney disease phenotypes and we investigated, in a subset of patients, the modulating role of albuminuria on kidney disease progression. Methods Clinical data of 1395 patients with T1DM were extracted from electronic medical records. Results Albuminuria was detected in 676 (48.5%) patients, with the remaining 719 (51.5%) patients having normoalbuminuric renal impairment. Those with albuminuria showed an evident worse cardiovascular risk profile as compared to patients with normoalbuminuria. A subgroup of 582 patients was followed up over a 4-year period. One hundred and twenty five patients (21.5%) showed a loss of eGFR > 30%. The proportion of patients reaching the renal outcome was significantly higher among those with baseline albuminuria as compared to patients with normoalbuminuria (P

Abstract We evaluated 2,656 patients with type 1 diabetes mellitus and preserved renal function from the database of the Italian Association of Clinical Diabetologists network to identify clinical predictors for the development of chronic kidney disease. We measured estimated glomerular filtration rate (eGFR), urinary albumin excretion, HbA1c, lipids, blood pressure. Over a 5-year period 4.3% (n = 115) developed reduced eGFR (

Type 2 Diabetes (T2D) in elderly patients is challenging and it may have a strong impact on patients’ quality of life. In this study we evaluated whether personal, clinical, or gender-related variables may influenceDiabetes Specific Quality of Life(DSQoL) and locus of control (LOC) scores in a group of 100 elderly T2D outpatients (60% men, 40% women; mean age 72 years) on oral hypoglycaemic drugs and in good metabolic control (mean HbA1c 6.7%). Overall, women showed a greater cognitive impairment and a lower autonomy in daily lifeas compared to men. Mean DSQoL scores indicated a good quality of life, with a lower level of satisfaction in women (P=0.009).As for LOC, there was a high prevalence of the internal domain, indicating that these subjects had a good awareness of their own role in diabetes’s management. Women reached lower scores in the LOC external domain, suggesting that external factors were perceived as less important determinants of diabetes’ control in elderly women as compared to men (P=0.048). After stratifying all study variables according to QoL and LOC domains, only diabetes duration and hypoglycemic episodes were significantly associated with QoL, whereas only gender and the number of outpatient visits during the previous two years were associated with LOC domains. In conclusion, in elderly T2D patients QoL and LOC scores are clearly influenced by a number of clinical factors, including gender.

We constantly process top-down and bottom-up inputs concerning our own body that interact to form body representations (BR). Even if some evidence showed BR deficits in children with cerebral palsy, a systematic study that evaluates different kinds of BR in these children, taking into account the possible presence of a general deficit affecting non-body mental representations, is currently lacking. Here we aimed at investigating BR (i.e., Body Semantics, Body Structural Representation and Body Schema) in children with cerebral palsy (CP) taking into account performance in tasks involving body stimuli and performance in tasks involving non-body stimuli. Thirty-three CP (age range: 5–12 years) were compared with a group of 103 typically-developing children (TDC), matched for age and sex. 63.64% of children with CP showed a very poor performance in body representation processing. Present data also show alterations in different body representations in CP in specific developmental stages. In particular, CP and TDC performances did not differ between 5 to 7 years old, whereas CP between 8 and 12 years old showed deficits in the Body Structural Representation and Body Schema but not in Body Semantics. These findings revealed the importance of taking into account the overall development of cognitive domains when investigating specific stimuli processing in children who do not present a typical development and were discussed in terms of their clinical implications.

We performed a real-life analysis of clinical and laboratory parameters, in orally treated T2DM patients aiming at identifying predictors of insulin treatment initiation. Overall, 366955 patients (55.8% males, age 65 ± 11 years, diabetes duration 7 ± 8 years) were followed up between 2004 and 2011. Each patient was analyzed step-by-step until either eventually starting insulin treatment or getting to the end of the follow-up period. Patients switching to insulin showed a worse global risk profile, longer disease duration (10 ± 9 years vs. 6 ± 7 years, respectively; p

BackgroundApparent treatment resistant hypertension (aTRH) is highly prevalent in patients with type 2 diabetes mellitus (T2D) and entails worse cardiovascular prognosis. The impact of aTRH and long‐term achievement of recommended blood pressure (BP) values on renal outcome remains largely unknown. We assessed the role of aTRH and BP on the development of chronic kidney disease in patients with T2D and hypertension in real‐life clinical practice. Methods and ResultsClinical records from a total of 29 923 patients with T2D and hypertension, with normal baseline estimated glomerular filtration rate and regular visits during a 4‐year follow‐up, were retrieved and analyzed. The association between time‐updated BP control (ie, 75% of visits with BP

Type 2 diabetes mellitus (T2DM) is the leading cause of chronic kidney disease (CKD). Diabetic nephropathy (DN) is determined by specific pathological structural and functional alterations of the kidneys in patients with diabetes, and its clinical manifestations are albuminuria and decline of glomerular filtration rate (GFR). Apart from renin−angiotensin−aldosterone system (RAAS) inhibitors, no other drugs are currently available as therapy for diabetic kidney disease (DKD). Glucagon-like peptide-1 receptor (GLP-1R) agonists are a new class of anti-hyperglycemic drugs which have been demonstrated to prevent the onset of macroalbuminuria and reduce the decline of GFR in diabetic patients. These drugs may exert their beneficial actions on the kidneys through blood glucose- and blood pressure (BP)-lowering effects, reduction of insulin levels and weight loss. Clinical benefits of GLP-1R agonists were acknowledged due to data from large randomized phase III clinical trials conducted to assess their cardiovascular(CV) safety. These drugs improved renal biomarkers in placebo-controlled clinical studies, with effects supposed to be independent of the actions on glycemic control. In this review, we will focus on the actions of GLP-1R agonists on glucose metabolism and kidney physiology, and evaluate direct and indirect mechanisms through which these drugs may confer renal protection.

Metabolic Syndrome (Mets) and increased serum uric acid (SUA), are well known renal risk predictors and often coexist in patients with type 2 diabetes (T2D). Whether they independently contribute to the onset of CKD is at present unclear.Within the AMD Annals database we identified patients with T2D and normal renal function and urine albumin excretion at baseline and regular follow-up visits during a 4-year period. Blood pressure, BMI, HDL, triglycerides, and SUA were available in 14,267 patients. The association between Mets and/or hyperuricemia (HU, top fifth gender specific quintile) and the occurrence of renal outcomes were evaluated.At baseline 59% of patients (n = 8,408) showed Mets and 18% (n = 2,584) HU. Over the 4-year follow-up, 14% (n = 1,990) developed low eGFR (i.e. below 60 mL/min/1.73 m2), and 26% (n = 3,740) albuminuria. After adjustment for confounders, BP≥130/85, low HDL, triglycerides ≥150 and HU were independently related to the development of low eGFR (1.57, P

We evaluated gender-differences in quality of type 1 diabetes (T1DM) care. Starting from electronic medical records of 300 centers, 5 process indicators, 3 favorable and 6 unfavorable intermediate outcomes, 6 treatment intensity/appropriateness measures and an overall quality score were measured. The likelihood of women vs. men (reference class) to be monitored, to reach outcomes, or to be treated has been investigated through multilevel logistic regression analyses; results are expressed as Odd Ratios (ORs) and 95% confidence intervals (95%CIs). The inter-center variability in the achievement of the unfavorable outcomes was also investigated. Overall, 28,802 subjects were analyzed (45.5% women). Women and men had similar age (44.5±16.0 vs. 45.0±17.0 years) and diabetes duration (18.3±13.0 vs. 18.8±13.0 years). No between-gender differences were found in process indicators. As for intermediate outcomes, women showed 33% higher likelihood of having HbA1c ≥8.0% (OR = 1.33; 95%CI: 1.25-1.43), 29% lower risk of blood pressure ≥140/90 mmHg (OR = 0.71; 95%CI: 0.65-0.77) and 27% lower risk of micro/macroalbuminuria (OR = 0.73; 95%CI: 0.65-0.81) than men, while BMI, LDL-c and GFR did not significantly differ; treatment intensity/appropriateness was not systematically different between genders; overall quality score was similar in men and women. Consistently across centers a larger proportion of women than men had HbA1c ≥8.0%, while a smaller proportion had BP ≥140/90 mmHg. No gender-disparities were found in process measures and improvements are required in both genders. The systematic worse metabolic control in women and worse blood pressure in men suggest that pathophysiologic differences rather than the care provided might explain these differences.

Background. Dyslipidemia contribute to the excess of coronary heart disease (CHD) risk observed in women with type 2 diabetes (T2DM). Low density lipoprotein-cholesterol (LDL-C) is the major target for CHD prevention, and T2DM women seem to reach LDL-C targets less frequently than men. Aim. To explore age- and gender-related differences in LDL-C management in a large sample of outpatients with T2DM. Results. Overall, 415.294 patients (45.3% women) from 236 diabetes centers in Italy were included. Women were older and more obese, with longer diabetes duration, higher total-cholesterol, LDL-C, and HDL-C serum levels compared to men (P