Ospedale Pesenti Fenaroli

Bergamo, Italy

Ospedale Pesenti Fenaroli

Bergamo, Italy

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Derosa G.,University of Pavia | Franzetti I.,Metabolic Unit | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 5 more authors.
Diabetes Research and Clinical Practice | Year: 2012

Aims: To evaluate the impact on glycemic control, insulin resistance, and insulin secretion of sitagliptin. +. metformin compared to metformin in type 2 diabetic patients. Methods: Patients were instructed to take metformin for 8 ± 2 months, then they were randomly assigned to sitaglipin 100. mg or placebo for 12 months. We evaluated at 3, 6, 9, and 12 months: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin/fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, adiponectin (ADN), and high sensitivity-C reactive protein (Hs-CRP). Before, and after 12 months since the addition of sitagliptin, patients underwent a combined euglycemic hyperinsulinemic and hyperglycemic clamp, with subsequent arginine stimulation. Results: Both treatments similarly decreased body weight, and BMI; on the other hand, they both improved glycemic control, glucagon and HOMA-IR, but sitagliptin. +. metformin were more effective in reducing these parameters. Sitagliptin. +. metformin, but not placebo. +. metformin, decreased FPPr, FPPR/FPI ratio, and increased C-peptide values, even if no differences between the groups were recorded. Sitaglitin. +. metformin gave also a greater increase of HOMA-β, M value, C-peptide response to arginine and disposition index compared to placebo. +. metformin group. Conclusions: Other than improving glycemic control, sitagliptin. +. metformin also improved β-cell function better than metformin alone. © 2012 Elsevier Ireland Ltd.


Derosa G.,University of Pavia | Franzetti I.G.,Regional Hospital | Querci F.,Ospedale Pesenti Fenaroli | Ciccarelli L.,RSA Villa Mafalda | And 3 more authors.
Diabetic Medicine | Year: 2012

Aim To quantify how much exenatide added to metformin improves β-cell function, and to evaluate the impact on glycaemic control, insulin resistance and inflammation compared with metformin alone. Methods A total of 174 patients with Type 2 diabetes with poor glycaemic control were instructed to take metformin for 8±2months, then they were randomly assigned to exenatide (5μg twice a day for the first 4weeks and forced titration to 10μg twice a day thereafter) or placebo for 12months. At 12months we evaluated anthropometric measurements, glycaemic control, insulin resistance and β-cell function variables, glucagon, adiponectin, high sensitivity-C reactive protein and tumour necrosis factor-α. Before and after 12months, patients underwent a combined euglycaemic hyperinsulinaemic and hyperglycaemic clamp, with subsequent arginine stimulation. Results Exenatide+metformin gave a greater decrease in body weight, glycaemic control, fasting plasma proinsulin and insulin and their ratio, homeostasis model assessment for insulin resistance (HOMA-IR), and glucagon values and a greater increase in C-peptide levels, homeostasis model assessment β-cell function index (HOMA-β) and adiponectin compared with placebo+metformin. Exenatide+metformin decreased waist and hip circumference, and reduced concentrations of high sensitivity-C reactive protein and tumour necrosis factor-α. Exenatide+metformin gave a greater increase in M value (+34%), and disposition index (+55%) compared with placebo+metformin; first (+21%) and second phase (+34%) C-peptide response to glucose and C-peptide response to arginine (+25%) were also improved by exenatide+metformin treatment, but not by placebo+metformin. Conclusion Exenatide is effective not only on glycaemic control, but also in protecting β-cells and in reducing inflammation. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.


Derosa G.,University of Pavia | Cicero A.F.G.,University of Bologna | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Journal of the American Society of Hypertension | Year: 2013

The purpose of this study was to evaluate a fixed olmesartan/amlodipine combination on blood pressure control, lipid profile, insulin sensitivity, and some inflammatory markers compared with single-drug monotherapy. A total of 276 hypertensive patients were randomly assigned to olmesartan 20 mg, amlodipine 10 mg, or a single pill containing olmesartan/amlodipine combination 20/5 mg for 12 months. We evaluated the following at baseline and after 6 and 12 months: body weight, body mass index, systolic (SBP) and diastolic blood pressures (DBP), fasting plasma glucose (FPG), fasting plasma insulin (FPI), lipid profile, tumor necrosis factor-α (TNF-α), retinol binding protein-4 (RBP-4), and interleukins 6 and 7 (IL-6 and IL-7). At baseline, and after 6 and 12 months, patients underwent an euglycemic, hyperinsulinemic clamp. The olmesartan/amlodipine combination provided a greater decrease of SBP and DPB compared with amlodipine and olmesartan monotherapies. The olmesartan/amlodipine combination decreased FPG after 12 months compared with amlodipine monotherapy. The combination decreased FPI and homeostasis model assessment index and increased M value both compared with baseline and with olmesartan and amlodipine monotherapies. Olmesartan/amlodipine decreased IL-7, but not IL-6, compared with single drug components. The olmesartan/amlodipine combination is effective and safe in reducing blood pressure and has some additive effects not shown by single drugs, such as an improvement of IL-7. © 2013 American Society of Hypertension. All rights reserved.


Derosa G.,University of Pavia | Cicero A.F.G.,University of Bologna | Franzetti I.G.,Regional Hospital | Querci F.,Ospedale Pesenti Fenaroli | And 4 more authors.
Diabetic Medicine | Year: 2013

Aims: To evaluate which triple oral therapy between metformin + pioglitazone + sitagliptin and metformin + pioglitazone + glibenclamide can be more useful in improving glycaemic control and should be preferred in clinical practice. Methods: During the 2-year run-in period, patients were instructed to take metformin monotherapy for the first year, then a combination of metformin and pioglitazone for the second year, then patients were randomized to add glibenclamide or sitagliptin to the dual combination of metformin and pioglitazone for another year. Results: Body weight reached with sitagliptin at 36 months was lower than that reached with glibenclamide. Fasting plasma insulin and homeostasis model assessment of insulin resistance were significantly increased by triple therapy with glibenclamide and decreased by that with sitagliptin. While sitagliptin did not change homeostasis model assessment of β-cell function, this value was significantly increased by glibenclamide. Fasting plasma proinsulin was not influenced by triple oral therapy including glibenclamide, while it was decreased by the therapy including sitagliptin compared to glibenclamide. Triple oral therapy with sitagliptin better improved β-cell function measures compared with the glibenclamide therapy. Conclusions: Sitagliptin should be preferred to glibenclamide as an addition to the metformin + pioglitazone combination for its better protection of β-cell secretion and its neutral effect on body weight. © 2013 Diabetes UK.


Derosa G.,University of Pavia | Franzetti I.G.,Regional Hospital | Querci F.,Ospedale Pesenti Fenaroli | Ciccarelli L.,RSA Villa Mafalda | And 3 more authors.
Pharmacotherapy | Year: 2013

STUDY OBJECTIVE To evaluate the effects of exenatide on some inflammatory markers and to quantify the effect of exenatide on b-cell function. DESIGN A randomized, double-blind, placebo-controlled trial. SETTING Seven hospitals in Italy. PATIENTS A total of 174 white treatment-naive adults with type 2 diabetes and a glycated hemoglobin (HbA1c) level higher than 7.5%. INTERVENTION After an open-label run-in period of 8-2 months with metformin, patients were randomized to take exenatide (5 lg twice/day for the first 4 weeks, 10 lg twice/day thereafter) or a placebo volume equivalent for 12 months. MEASUREMENTS AND MAIN RESULTS Body mass index, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index, homeostasis model assessment b-cell function index (HOMA-b), fasting plasma proinsulin (FPPr), proinsulin-to-fasting plasma insulin ratio (Pr:FPI ratio), C-peptide, glucagon, vaspin, chemerin, and resistin were evaluated at baseline, at randomization, and at 3, 6, 9, and 12 months. Patients also underwent a combined euglycemic, hyperinsulinemic, and hyperglycemic clamp with subsequent arginine stimulation to assess insulin sensitivity and insulin secretion. HbA1c was significantly improved with exenatide plus metformin compared with placebo plus metformin. Exenatide plus metformin was also significantly more effective than placebo plus metformin in increasing HOMA-b C-peptide, and all measures of b-cell function after the euglycemic hyperinsulinemic and hyperglycemic clamp. We observed that exenatide plus metformin also reduced resistin compared with placebo plus metformin. No variations in vaspin and chemerin were noted in group-to-group comparisons. We observed a significant correlation between M value increase, an index of insulin sensitivity, and a decrease in inflammatory parameters in the exenatide plus metformin group. CONCLUSIONS The combination of exenatide plus metformin was more effective than metformin alone in improving glycemic control, b-cell function, and inflammatory parameters. © 2013 Pharmacotherapy Publications, Inc.


Derosa G.,University of Pavia | D'angelo A.,University of Pavia | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Expert Opinion on Pharmacotherapy | Year: 2012

Aim: To evaluate the impact on glycemic control, insulin secretion and on insulin resistance of a sitagliptin + metformin combination compared to metformin monotherapy in type 2 diabetic, naïve to treatment, patients. Materials and methods: A total of 178 Caucasian type 2 diabetic patients were randomized to take sitagliptin 100 mg once a day or placebo in addition to previously taken metformin, for 12 months. The authors evaluated at 3, 6, 9, and 12 months: body mass index (BMI), glycemic control, fasting plasma insulin (FPI), HOMA-IR, HOMA-β, fasting plasma proinsulin (FPPr), proinsulin/fasting plasma insulin ratio (Pr/FPI ratio), C-peptide, glucagon, retinol binding protein-4 (RBP-4), visfatin, and chemerin. Before and 12 months after the addition of sitagliptin, patients underwent tests to assess insulin sensitivity and insulin secretion. Results: Sitagliptin + metformin gave a better decrease of glycemic control, HOMA-IR and glucagon levels compared to placebo + metformin; sitagliptin + metformin also better increased HOMA-β and all β-cell measurements recorded after the clamp. Regarding adipocytokines, sitagliptin + metformin better reduced RBP-4, visfatin and chemerin levels, compared to placebo + metformin. Conclusion: When metformin alone is not enough to reach an adequate glycemic control, sitagliptin can be a valid option, because of its effects in reducing insulin resistance and in preserving β-cell function. © Informa UK, Ltd.


Derosa G.,University of Pavia | D'Angelo A.,University of Pavia | Querci F.,Ospedale Pesenti Fenaroli | Fogari E.,University of Pavia | And 2 more authors.
Internal Medicine | Year: 2013

Objective The effects of dipeptidyl peptidase-4 (DPP-4) inhibition on adipose tissue inflammation remain obscure. The aim of this study was to evaluate the effects of the addition of sitagliptin on the β-cell function and various inflammatory biomarkers in type 2 diabetic patients. Methods After a run-in period of taking metformin, 178 diabetic patients with poor glycemic control were randomized to take sitagliptin at a dose of 100 mg once a day or a placebo in addition to metformin for 12 months. We evaluated the following parameters at three, six, nine and twelve months: body mass index (BMI), glycemic control, the homeostasis model assessment insulin resistance index (HOMA-IR), the homeo-stasis model assessment β-cell function index (HOMA-β), the proinsulin/fasting plasma insulin ratio (Pr/FPI ratio) and the levels of fasting plasma insulin (FPI), fasting plasma proinsulin (FPPr), C-peptide, glucagon, resistin, vaspin, omentin-1 and tumor necrosis factor-α (TNF-α). Before and twelve months after the addition of sitagliptin, the patients underwent combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation to assess insulin sensitivity and secretion. Results Treatment with sitagliptin + metformin was more effective than placebo + metformin in improving glycemic control, the HOMA-IR and the glucagon level and increasing the HOMA-β and all β-cell measurements after combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation. Regarding inflammatory biomarkers, sitagliptin + metformin more effectively reduced the levels of resistin, vaspin and omentin-1 than placebo + metformin. Conclusion When treatment with metformin alone is not adequate for obtaining glycemic control, the addition of sitagliptin can be considered due to its actions in preserving the β-cell function and reducing the levels of biomarkers of inflammation. © The Japanese Society of Internal Medicine.


Derosa G.,University of Pavia | Querci F.,Ospedale Pesenti Fenaroli | Franzetti I.,S Antonio Abate Hospital | Dario Ragonesi P.,S Carlo Hospital | And 2 more authors.
Hypertension Research | Year: 2015

The aim of this study was to evaluate the effects of barnidipine+losartan compared with telmisartan+hydrochlorothiazide on several parameters of insulin sensitivity in patients with hypertension and type 2 diabetes mellitus. We enrolled 148 normocholesterolemic patients with mild-to-moderate hypertension and type 2 diabetes mellitus. Patients were treated with barnidipine, 20 mg day-1, in combination with losartan, 100 mg day-1, or with telmisartan+hydrochlorothiazide, 80/12.5 mg day-1, for 6 months. We assessed blood pressure (BP) on a monthly basis; additionally, blood samples were collected to assess, at baseline and after 6 months, the following parameters: fasting plasma glucose; glycated hemoglobin; fasting plasma insulin; HOMA index; and some adipocytokines, such as adiponectin (ADN), resistin, leptin, visfatin and vaspin. Patients were also subjected to an euglycemic hyperinsulinemic clamp to assess the M value and glucose infusion rate to ascertain their insulin sensitivity. One hundred and forty-one patients completed the study. The BP was reduced in both groups, although the reduction was greater with barnidipine+losartan (P<0.001 vs. baseline and P<0.01 vs. telmisartan+hydrochlorothiazide). Barnidipine+losartan increased the M value and glucose infusion rate during the euglycemic hyperinsulinemic clamp (P<0.05 vs. baseline and vs. telmisartan+hydrochlorothiazide). With respect to the levels of adipocytokines, ADN was increased (P<0.05), and resistin and leptin were reduced from baseline with barnidipine+losartan (P<0.05 vs. baseline), but they were not reduced with telmisartan+hydrochlorothiazide. Visfatin and vaspin were reduced by barnidipine+losartan compared with baseline (P<0.05). The adipocytokine levels obtained with barnidipine+losartan were significantly better than those obtained with telmisartan+hydrochlorothiazide (P<0.05 for all parameters). In addition to providing a greater BP reduction, barnidipine+losartan improved the insulin sensitivity, as assessed by an euglycemic hyperinsulinemic clamp, and improved some of the adipocytokines related to insulin resistance. © 2015 The Japanese Society of Hypertension.


Parazzini F.,Centro Studi GISED | Cipriani S.,University of Milan | Zinetti C.,Centro Studi GISED | Chatenoud L.,Irccs Instituto Of Ricerche Farmacologiche Mario Negri | And 5 more authors.
Pediatric Allergy and Immunology | Year: 2014

Objective: To analyze the effects of pregnancy and early events in the newborn on the risk of subsequent atopic dermatitis (AD) during the first year of life. Patients and Methods: This is a prospective multicenter cohort study of newborns during the first year of life. Newborns identified on random days in three obstetrics departments in the area of Bergamo, Lombardy, Northern Italy, were eligible. At baseline, the mothers were interviewed by medical staff during their stay in hospital after delivery. At 6 and 12 months after delivery, a postal questionnaire was sent to the parents. Relative risks were calculated with and without adjustment by multiple regression analysis. Results: A total of 1081 newborns entered the study: 796 (74%) parents answered the 12-month questionnaire. Hundred and thirty-eight (17%) reported a diagnosis of AD at 6 months and 222 (28%) at 12 months. Parental history of AD and/or asthma was associated with an increased risk of AD (RR 1.5, 95%CI 1.1-2.0). Birth weight was slightly associated with an increased risk of AD: RR 1.04, 95%CI 1.001-1.08 (continuous variable, increment of 100 grams). No association emerged between breast feeding, smoking, and risk of AD. Conclusions: This study in an Italian offspring cohort points to family history of atopic diseases and body weight at birth as relevant risk factors. The study was unable to document associations with other perinatal factors particularly breast feeding and parental smoking in the perinatal period. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.


Derosa G.,University of Pavia | Franzetti I.,S Antonio Abate Hospital | Querci F.,Ospedale Pesenti Fenaroli | Romano D.,University of Pavia | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

Aim: To compare, using a continuous glucose monitoring (CGM) system, the effect on glycaemic variability of insulin glargine, detemir and lispro protamine. Methods: A total of 49 white people with type 1 diabetes, not well controlled by three times daily insulin lispro, taken for at least 2months before study and on a stable dose, were enrolled. The study participants were randomized to add insulin glargine, detemir or lispro protamine, once daily, in the evening. We used a CGM system, the iPro Digital Recorder (Medtronic MiniMed, Northridge, CA, USA) for 1week. Glycaemic control was assessed according to mean blood glucose values, the area under the glucose curve above 3.9mmol/l (AUC>3.9) or above 10.0mmol/l (AUC>10.0), and the percentage of time spent with glucose values >3.9 or >10.0mmol/l. Intraday glycaemic variability was assessed using standard deviation (s.d.) values, the mean amplitude of glycaemic excursions and continuous overlapping of net glycaemic action. Day-to-day glycaemic variability was assessed using the mean of daily differences. Results: The s.d. was found to be significantly lower with insulin lispro protamine and glargine compared with insulin detemir. AUC>3.9 was higher and AUC>10.0 was lower with insulin lispro protamine and glargine compared with detemir. The mean amplitude of glycaemic excursions and continuous overlapping net glycaemic action values were lower with insulin lispro protamine and glargine compared with detemir. In addition, the mean of daily differences was significantly lower with insulin lispro protamine and glargine compared with detemir. Fewer hypoglycaemic events were recorded during the night-time with insulin lispro protamine compared with glargine and detemir. Conclusions: The results suggest that insulin lispro protamine and glargine are more effective than detemir in reducing glycaemic variability and improving glycaemic control in people with type 1 diabetes. Insulin lispro protamine seems to lead to fewer hypoglycaemic events than other insulin regimens. © 2015 John Wiley & Sons Ltd.

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