D Giugliano

Second University of Naples, Napoli, Campania, Italy

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Publications (479)2702.84 Total impact

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    ABSTRACT: Glucagon-like peptide-1 (GLP-1) receptor agonists are available for the treatment of type 2 diabetes. We assessed the efficacy of exenatide and liraglutide to reach the HbA(1c) target of <7% in people with type 2 diabetes. We conducted an electronic search for randomized controlled trials (RCTs) involving GLP-1 agonists through September 2010. RCTs were included if they lasted at least 12 weeks, included 30 patients or more, and reported the proportion of patients reaching the HbA(1c) target of <7%. A total of 25 RCTs reporting 28 comparisons met the selection criteria, which included 9771 study participants evaluated for the primary endpoint, 5083 treated with a GLP-1 agonist and 4688 treated with placebo or a comparator drug. GLP-1 agonists showed a statistically significant reduction in HbA(1c) compared to placebo and the proportion of participants achieving the HbA(1c) goal <7% was 46% for exenatide, 47% for liraglutide, and 63% for exenatide LAR (long-acting release). Moreover, the reduction of the HbA(1c) level and the rate of HbA(1c) goal attainment were higher for both exenatide LAR and liraglutide, as compared to comparator drugs. Higher rates of hypoglycemia with exenatide b.i.d. and liraglutide compared to placebo were associated with the concomitant use of a sulfonylurea. Exenatide b.i.d. and liraglutide were associated with weight loss compared to placebo or other antidiabetic drugs. Baseline HbA(1c) was the best predictor for achievement of A1c target (overall weighted R(2) value = 0.513, p < 0.001). A greater proportion of patients with type 2 diabetes can achieve the HbA(1c) goal <7% with GLP-1 agonists compared to placebo or other antidiabetic drugs; in absolute terms, exenatide LAR was best for the attainment of the HbA(1c) goal.
    Current Medical Research and Opinion 06/2011; 27(8):1519-28. · 2.37 Impact Factor
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    ABSTRACT: Insulin analogues are increasingly used in patients with type 2 diabetes. We performed a systematic review of randomized controlled trials (RCTs) to assess the role of insulin analogues to reach different hemoglobin A1c (HbA1c) targets (from 6.5% to 8%) in type 2 diabetic patients. RCTs involving insulin regimens (basal, prandial, biphasic, and basal-bolus) with insulin analogues in type 2 diabetes were identified through electronic searches (MEDLINE, EMBASE, CINAHL, and The Cochrane Library) through August 2010. We included any study arm of RCTs if they were at least 12 weeks in duration, and reported HbA1c as an outcome and the proportion of diabetic patients reaching the HbA1c target of <7%. The proportion of patients with HbA1c <6.5%, <7.0%, <7.5%, and <8.0% was estimated using mean and standard deviation of HbA1c at the end of treatment. We identified 53 RCTs, with 92 arms, and 32,689 patients. The proportion of patients at target was highest with the basal-bolus regimen, and ranged from 27.8% (95% CI, 22.2-34%) for the HbA1c target <6.5% to 88% (CI 83-92%) for the HbA1c target <8%. Biphasic insulin regimen ranked second at any HbA1c target, while prandial and basal regimens alternated across different HbA1c targets. At any HbA1c target, basal-bolus insulin regimens with insulin analogues obtained the best results, which may be useful for detailing the best treatment effect in individual patients.
    Journal of diabetes and its complications 05/2011; 25(4):275-81. · 2.11 Impact Factor
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    ABSTRACT: We performed a meta-analysis of randomised controlled trials (RCTs) with insulin analogues in type 2 diabetes utilising a least-squared regression model in order to assess the relationship between baseline HbA1c, the magnitude of HbA1c decrease and attainment of HbA1c target of < 7%. Randomised controlled trials involving insulin regimens (basal, prandial, biphasic and basal-bolus) were identified through electronic searches (MEDLINE, EMBASE, CINAHL and The Cochrane Library) through September 2010. We included any study arm of RCTs if they were at least 12 weeks in duration; the number of patients in any arm was more than 30 and reported the baseline HbA1c and change from baseline HbA1c. We found 87 studies, with a total of 135 arms, and 38,803 patients. The weighted R(2) values for the overall analysis assessing the association between baseline HbA1c and absolute change in HbA1c or the proportion of patients at target were 0.485 (p < 0.001) and 0.146 (p < 0.001), respectively. Subanalyses of insulin regimens for the association between basal HbA1c and absolute decrease of HbA1c produced weighted R(2), which were significant for all insulin regimens with the highest association for basal-bolus (R(2) = 0.719, p < 0.001). The strong positive relationship between baseline HbA1c and the magnitude of HbA1c change we found in RCTs using insulin analogues in type 2 diabetes should be considered when assessing the clinical efficacy of insulin therapies.
    International Journal of Clinical Practice 05/2011; 65(5):602-12. · 2.43 Impact Factor
  • Dario Giugliano, Katherine Esposito
    JAMA The Journal of the American Medical Association 04/2011; 305(15):1591-2. · 29.98 Impact Factor
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    ABSTRACT: We conducted a systematic review of randomized controlled trials that evaluated the effectiveness of insulin regimens (basal, biphasic, prandial, and basal-bolus) with insulin analogues to reach the haemoglobin A1c target of <7% in patients with type 2 diabetes. We identified 48 trials, with 85 arms and 30,588 patients. There were 38 arms using basal insulin, with 17,588 patients, and a primary outcome of 41.4% (95% CI=35.6-47.4%); 26 arms using biphasic insulin, with 9237 patients, and a primary outcome of 46.5% (40.8-52.3%); 9 arms using prandial insulin, with 1605 patients, and a primary outcome of 39.6% (95% CI, 28.6-51.3%); and 12 arms using basal-bolus insulin, with 2114 patients, and a primary outcome of 53.9% (43.5-64). The high heterogeneity was related, in part, to first time insulin use, final insulin dose, and use of oral drug. The overall incidence of hypoglycaemia ranged from 0 to 4.71 events/patient/30 days; weight gain ranged from 1.75 kg for basal to 3 kg for biphasic insulin. The HbA1c target of <7% can be achieved in a percentage of type 2 diabetic patients ranging from 40% to 54% depending on the particular insulin regimen.
    Diabetes research and clinical practice 04/2011; 92(1):1-10. · 2.74 Impact Factor
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    ABSTRACT: The aim of this study was to meta-analyze epidemiological studies and clinical trials that have assessed the effect of a Mediterranean diet on metabolic syndrome (MS) as well as its components. The Mediterranean diet has long been associated with low cardiovascular disease risk in adult population. The authors conducted a systematic review and random effects meta-analysis of epidemiological studies and randomized controlled trials, including English-language publications in PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials until April 30, 2010; 50 original research studies (35 clinical trials, 2 prospective and 13 cross-sectional), with 534,906 participants, were included in the analysis. The combined effect of prospective studies and clinical trials showed that adherence to the Mediterranean diet was associated with reduced risk of MS (log hazard ratio: -0.69, 95% confidence interval [CI]: -1.24 to -1.16). Additionally, results from clinical studies (mean difference, 95% CI) revealed the protective role of the Mediterranean diet on components of MS, like waist circumference (-0.42 cm, 95% CI: -0.82 to -0.02), high-density lipoprotein cholesterol (1.17 mg/dl, 95% CI: 0.38 to 1.96), triglycerides (-6.14 mg/dl, 95% CI: -10.35 to -1.93), systolic (-2.35 mm Hg, 95% CI: -3.51 to -1.18) and diastolic blood pressure (-1.58 mm Hg, 95% CI: -2.02 to -1.13), and glucose (-3.89 mg/dl, 95% CI:-5.84 to -1.95), whereas results from epidemiological studies also confirmed those of clinical trials. These results are of considerable public health importance, because this dietary pattern can be easily adopted by all population groups and various cultures and cost-effectively serve for primary and secondary prevention of the MS and its individual components.
    Journal of the American College of Cardiology 03/2011; 57(11):1299-313. · 14.09 Impact Factor
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    ABSTRACT: We conducted a systematic review of randomized controlled trials (RCTs) that evaluated the effectiveness of insulin regimens with insulin analogs to reach the glycosylated hemoglobin (HbA1c) target of <7% in patients with type 2 diabetes. RCTs involving insulin regimens (basal, prandial, biphasic, and basal-bolus) with insulin analogs in type 2 diabetes were identified through electronic searches [MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and The Cochrane Library] through September, 2010. We included any study arm of RCTs if they were at least 12 weeks in duration and reported HbA1c as an outcome. We identified 55 RCTs, with 96 arms and 33,244 patients, that reported the HbA1c target, and 32 RCTs, with 32 arms and 5,559 patients, that did not report the target. The missing targets were calculated with an algorithm that explained 88% of variability between studies. Overall, the proportion of patients at target (HbA1c <7%) was 37.2% [95% confidence interval (CI), 31.5-43.1%] with basal insulin, 35.3% (28.9-42.1%) with biphasic insulin, 37.5% (27.7-47.9%) with prandial insulin, and 51.2% (41.4-61.1%) for basal-bolus insulin, with high heterogeneity (I(2) >80% for all). The HbA1c target <7% can be achieved in a proportion of patients ranging from 35% to 51%, depending on the particular insulin regimen. At least one half of patients with type 2 diabetes receiving insulin analogs do not reach the HbA1c target.
    Metabolic syndrome and related disorders 03/2011; 9(3):167-76.
  • D Giugliano, K Esposito
    Diabetic Medicine 02/2011; 28(2):247. · 3.24 Impact Factor
  • Katherine Esposito, Dario Giugliano
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    ABSTRACT: Commentary on: CarterPGrayLJTroughtonJ. Fruit and vegetable intake and incidence of type 2 diabetes mellitus: systematic review and meta-analysis. BMJ2010;341:c4229.
    Evidence-based medicine 02/2011; 16(1):27-8.
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    ABSTRACT: Insulin analogs are increasingly used in patients with type 2 diabetes. We compared the effect of basal, biphasic, prandial, and basal-bolus insulin regimens with insulin analogs to reach the hemoglobin A(1c) (HbA(1c)) target of <7% in people with type 2 diabetes. We conducted an electronic search for randomized controlled trials (RCTs) involving insulin analogs. RCTs were included if they lasted at least 12 weeks, reported the proportion of diabetic patients reaching the HbA(1c) target of <7% (primary outcome), and the number of patients in any arm was >30. We found 16 RCTs, with 20 comparisons and 7,759 patients. A greater proportion of patients achieved the HbA(1c) goal of <7% with both biphasic (odds ratio 1.88 [95% CI 1.38-2.55]) and prandial (2.07 [1.16-3.69]) insulin compared with basal insulin; this was associated for biphasic insulin with greater hypoglycemia (event/patient/30 days, mean difference, 0.34 [range 0-0.69]) and weight gain in kg (1.0 kg [0.28-1.73]). Compared with biphasic insulin, the basal-bolus regimen was associated with a greater chance to reach the HbA(1c) goal (odds ratio 1.75 [95% CI 1.11-2.77]), with no greater hypoglycemia or weight gain. The effect of insulin analogs on long-term diabetes complications is still lacking. A greater proportion of type 2 diabetic patients can achieve the HbA(1c) goal <7% with biphasic or prandial insulin compared with basal insulin; in absolute terms, the basal-bolus regimen was best for the attainment of the HbA(1c) goal.
    Diabetes care 02/2011; 34(2):510-7. · 7.74 Impact Factor
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    ABSTRACT: We assessed the efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors vildagliptin, sitagliptin, saxagliptin and alogliptin to reach the haemoglobin HbA1c target of <7% in people with type 2 diabetes. We conducted an electronic search for randomized controlled trials (RCTs) involving DPP-4 inhibitors through September 2010. RCTs were included if they lasted at least 12 weeks, included 30 patients or more and reported the proportion of patients reaching the HbA1c target of <7%. A total of 43 RCTs reporting 52 comparisons met the selection criteria, which included 19 101 study participants evaluated for the primary endpoint, 10 467 treated with a DPP-4 inhibitor and 8634 treated with placebo or a comparator drug. DPP-4 inhibitors showed a statistically significant reduction in HbA1c compared to placebo and approximately 40% of participants achieved the HbA1c goal of <7%: this was associated with weight neutrality and no greater hypoglycaemia. The reduction of the HbA1c level and the rate of HbA1c goal attainment was not different from comparator drugs, with similar hypoglycaemia, and different effect on weight owing to the nature of comparator (metformin, sulfonylurea or glitazones). Baseline HbA1c was the best predictor for achievement of A1C target (overall weighted r(2) value = 0.410, p < 0.001). A greater proportion of type 2 diabetic patients can achieve the HbA1c goal <7% with DPP-4 inhibitors compared to placebo, with no weight gain, and no hypoglycaemic risk when used alone; DPP-4 inhibitors were not different from comparator drugs.
    Diabetes Obesity and Metabolism 02/2011; 13(7):594-603. · 5.18 Impact Factor
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    Archives of internal medicine 02/2011; 171(4):365-6. · 11.46 Impact Factor
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    Cardiology research and practice. 01/2011; 2011:386892.
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    ABSTRACT: Endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs) are markers of endothelial injury and repair. We compared the effects of pioglitazone versus metformin on the circulating numbers of EMPs and EPCs in patients with newly diagnosed type 2 diabetes. This was a randomized, double-blind, comparator-controlled, 24-week single-centre trial conducted in a Teaching Hospital in Naples, Italy. One hundred and ten people with newly diagnosed type 2 diabetes who were never treated with antihyperglycaemic drugs and had haemoglobin A1c (HbA1c) levels between 7 and 10% were given pioglitazone hydrochloride (15-45 mg/day) (n = 55) or metformin (1000-2000 mg/day) (n = 55) as an active comparator. Absolute change from baseline to final visit in circulating EMPs and EPCs and their ratio were the main outcomes. Baseline characteristics did not differ between the study groups. The decrease in circulating EMPs CD31+ [intergroup difference, -32 counts/µl (95% CI -51 to -9)] and the increase in EPCs CD34+/KDR+ [intergroup difference, 33 cells/10(6) events (95% CI 13 to 55)] were greater with pioglitazone versus metformin. EMPs/EPCs ratio was reduced with pioglitazone and unchanged with metformin [difference, -1.5 (95% CI -2.6 to -0.5), p < 0.001]. Participants assigned to pioglitazone gained more weight and experienced greater improvements in some coronary risk measures [high-density lipoprotein (HDL)-cholesterol, triglycerides, adiponectin and C-reactive protein (CRP)] than did those assigned to metformin. Compared with metformin, pioglitazone treatment improved the imbalance between endothelial damage and repair capacity and led to more favourable changes in coronary risk factors in patients with newly diagnosed type 2 diabetes.
    Diabetes Obesity and Metabolism 01/2011; 13(5):439-45. · 5.18 Impact Factor
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    ABSTRACT: We report the effects of a Mediterranean-style diet, with or without calorie restriction, on biomarkers of aging and oxidative stress in overweight men. 192 men were randomly assigned to either a Mediterranean-style diet or a conventional diet. The intervention program was based on implementation of a Mediterranean dietary pattern in the overweight group (MED diet group), associated with calorie restriction and increased physical activity in the obese group (lifestyle group). Both groups were compared with participants in two matched control groups (advice groups). After 2 years, there was a significant difference in weight loss between groups, which was -14 kg (95% CI -20 to -8) in lifestyle groups and -2.0 kg (-4.4 to 0) in the advice groups, with a difference of -11.9 kg (CI -19 to -4.7 kg, P < .001); moreover, there was a significant difference between groups at 2 years for insulin (P = .04), 8-iso-PGF2α (P = .037), glucose (P = .04), and adiponectin (P = .01). Prolonged adherence to a Mediterranean-style diet, with or without caloric restriction, in overweight or obese men is associated with significant amelioration of multiple risk factors, including a better cardiovascular risk profile, reduced oxidative stress, and improved insulin sensitivity.
    Cardiology research and practice. 01/2011; 2011:293916.
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    ABSTRACT: Glucagon-like peptide 1 (GLP-1) stimulates insulin secretion. However, GLP-1 also improves endothelial function in diabetes. Sixteen type 2 diabetic patients and 12 control subjects received a meal, an oral glucose tolerance test (OGTT), and two hyperglycemic clamps, with or without GLP-1. The clamps were repeated in diabetic patients after 2 months of strict glycemic control. During the meal, glycemia, nitrotyrosine, and plasma 8-iso prostaglandin F2α (8-iso-PGF2a) remained unchanged in the control subjects, whereas they increased in diabetic patients. Flow-mediated vasodilation (FMD) decreased in diabetes, whereas GLP-1 increased in both groups. During the OGTT, an increase in glycemia, nitrotyrosine, and 8-iso-PGF2a and a decrease in FMD were observed at 1 h in the control subjects and at 1 and 2 h in the diabetic patients. In the same way, GLP-1 increased in both groups at the same levels of the meal. During the clamps, in both the control subjects and the diabetic patients, a significant increase in nitrotyrosine and 8-iso-PGF2a and a decrease in FMD were observed, effects that were significantly reduced by GLP-1. After improved glycemic control, hyperglycemia during the clamps was less effective in producing oxidative stress and endothelial dysfunction and the GLP-1 administration was most effective in reducing these effects. Our data suggest that during the meal GLP-1 can simultaneously exert an incretin effect on insulin secretion and a protective effect on endothelial function, reasonably controlling oxidative stress generation. The ability of GLP-1 in protecting endothelial function seems to depend on the level of glycemia, a phenomenon already described for insulin secretion.
    Diabetes care 01/2011; 34(3):697-702. · 7.74 Impact Factor
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    ABSTRACT: Lifestyle intervention may reduce the risk of type 2 diabetes. The aim of this study was to investigate the role of dietary patterns in the prevention of type 2 diabetes. We did an electronic search through November 30, 2009, for prospective studies that evaluated the role of dietary patterns in type 2 diabetes prevention. Ten large prospective studies were identified, comprising more than 190,000 subjects free of diabetes at baseline, followed for a time ranging from 2 to 23 years, and 8,932 cases of incident diabetes. All ten studies showed consistent results: Relative risk reduction of type 2 diabetes ranged from 83% to 15%. Overall, adherence to a healthy dietary pattern was associated with reduced risk of developing type 2 diabetes: Combined mean difference  = -0.39, 95% confidence interval (CI) -0.54 to -0.24. The reduced risk of developing type 2 diabetes was still present after sensitivity analysis (-0.34, 95% CI -0.44 to -0.24). Dietary patterns characterized by high consumption of fruit and vegetables, whole grains, fish, and poultry, and by decreased consumption of red meat, processed foods, sugar-sweetened beverages, and starchy foods may retard the progression of type 2 diabetes. Healthy diets can help people to live more years without type 2 diabetes.
    Metabolic syndrome and related disorders 10/2010; 8(6):471-6.
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    ABSTRACT: The epidemiological evidence supporting a causal link between Mediterranean diets and body weight is contrasting. We evaluated the effect of Mediterranean diets on body weight in randomized controlled trials (RCTs) using a meta-analysis. We searched English and non-English publications in PubMed, Embase, Scopus, and the Cochrane Central Register of Controlled Trials from inception to January, 2010. Two evaluators independently selected and reviewed eligible studies. Sixteen randomized controlled trials, with 19 arms and 3,436 participants (1,848 assigned to a Mediterranean diet and 1,588 assigned to a control diet) were included. In a random-effects meta-analysis of all 19 arms, the Mediterranean diet group had a significant effect on weight [mean difference between Mediterranean diet and control diet, -1.75 kg; 95% confidence interval (CI), -2.86 to -0.64 kg] and body mass index (mean difference, -0.57 kg/m², -0.93 to -0.21 kg/m²). The effect of Mediterranean diet on body weight was greater in association with energy restriction (mean difference, -3.88 kg, -6.54 to -1.21 kg), increased physical activity (-4.01 kg, -5.79 to -2.23 kg), and follow up longer than 6 months (-2.69 kg, -3.99 to -1.38 kg). No study reported significant weight gain with a Mediterranean diet. Mediterranean diet may be a useful tool to reduce body weight, especially when the Mediterranean diet is energy-restricted, associated with physical activity, and more than 6 months in length. Mediterranean diet does not cause weight gain, which removes the objection to its relatively high fat content. These results may be useful for helping people to lose weight.
    Metabolic syndrome and related disorders 10/2010; 9(1):1-12.
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    ABSTRACT: We conducted a systematic review of the available studies that assessed the effect of a Mediterranean diet in type 2 diabetes. We searched publications up to 30 November 2009. Seventeen studies were included. Two large prospective studies report a substantially lower risk (83% and 35%, respectively) of type 2 diabetes in healthy people or in post-infarct patients with the highest adherence to a Mediterranean diet. Five randomized controlled trials have evaluated the effects of a Mediterranean diet, as compared with other commonly used diets, on indices of glycaemic control in subjects with type 2 diabetes. Improvement of fasting glucose and HbA1c levels was greater with a Mediterranean diet and ranged from 7 to 40mg/dl for fasting glucose, and from 0.1 to 0.6% for HbA1c. No trial reported worsening of glycaemic control with a Mediterranean diet. Two controlled trials in a secondary prevention setting demonstrated that post-infarct patients, including diabetic patients, had cardiovascular benefits from a Mediterranean diet. The evidence so far accumulated suggests that adopting a Mediterranean diet may help prevent type 2 diabetes, and also improve glycaemic control and cardiovascular risk in persons with established diabetes.
    Diabetes research and clinical practice 08/2010; 89(2):97-102. · 2.74 Impact Factor
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    ABSTRACT: To investigate the possibility of reversing endothelial dysfunction and inflammation by glucose normalization, antioxidants and insulin per se, in different subgroups of Type 1 diabetic patients. Three subgroups of Type 1 diabetic patients were studied: patients within 1 month of diagnosis (subgroup 1); patients with approximately 5 years' disease duration and with glycated haemoglobin (HbA(1c)) <or= 7.0% (subgroup 2) or > 7.0% since diagnosis (subgroup 3). Participants underwent four procedures: 2-h hyperglycaemic clamp followed by: (A) 12 h near-normalization of blood glucose, with the addition of vitamin C during the last 6 h; (B) 12-h vitamin C and near-normalization of blood glucose for the last 6 h; (C) both vitamin C and near-normalization of blood glucose for 12 h; (D) hyperglycaemic-hyperinsulinaemic clamp for 12 h, with the addition of vitamin C during the last 6 h. After 2 h of hyperglycaemia, markers of endothelial dysfunction, nitrotyrosine, 8-iso prostaglandin F2alpha, soluble intercellular adhesion molecule-1, soluble vascular adhesion molecule-1, interleukin (IL)-6 and IL-18 were increased in all the subgroups. Levels were normalized, at all time points, by treatments A, B and C in the subgroups 1 and 2. In the third subgroup, levels were normalized only by the simultaneous normalization of blood glucose and vitamin C treatment. During treatment D, the levels were improved at 6 h in all the subgroups, but normalized at 12 h only after vitamin C in subgroups 1 and 2, but not in subgroup 3. This study suggests that different subgroups of Type 1 diabetic patients react identically to acute hyperglycaemia and insulin, but differently to glucose normalization.
    Diabetic Medicine 08/2010; 27(8):911-7. · 3.24 Impact Factor

Publication Stats

14k Citations
2,702.84 Total Impact Points

Institutions

  • 1978–2014
    • Second University of Naples
      • • Dipartimento di Biochimica, Biofisica e Patologia Generale
      • • Faculty of Medicine and Surgery
      • • Centro di Eccellenza di Ricerca sulle Malattie Cardiovascolari
      Napoli, Campania, Italy
  • 2012
    • Ospedale San Giovanni Battista, ACISMOM
      Torino, Piedmont, Italy
  • 2011
    • Lilly Deutschland GmbH
      Homburg vor der Höhe, Hesse, Germany
    • National and Kapodistrian University of Athens
      • Faculty of Medicine
      Athens, Attiki, Greece
  • 2010–2011
    • IDIBAPS August Pi i Sunyer Biomedical Research Institute
      Barcino, Catalonia, Spain
  • 2007–2009
    • The University of Warwick
      • Warwick Medical School (WMS)
      Coventry, ENG, United Kingdom
  • 1992–2005
    • University of Udine
      • Department of Medical and Biological Sciences
      Udine, Friuli Venezia Giulia, Italy
  • 1976–2005
    • University of Naples Federico II
      • Department of Molecular Medicine and Medical Biotechnology
      Napoli, Campania, Italy
  • 2004
    • Università degli Studi del Sannio
      Benevento, Campania, Italy