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6. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., Capuano G., Vitale, M, Masulli, M, Rivellese, A, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo, P, Giorgino, F, Gnasso, A, Mannucci, E, Mazzotti, A, Nappo, R, Palena, A, Pata, P, Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, A, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, Capuano, G, Vitale M., Masulli M., Rivellese A. A., Bonora E., Cappellini F., Nicolucci A., Squatrito S., Antenucci D., Barrea A., Bianchi C., Bianchini F., Fontana L., Fornengo P., Giorgino F., Gnasso A., Mannucci E., Mazzotti A., Nappo R., Palena A. P., Pata P., Perriello G., Potenziani S., Radin R., Ricci L., Romeo F., Santini C., Scarponi M., Serra R., Timi A., Turco A. A., Vedovato M., Zavaroni D., Grioni S., Riccardi G., Vaccaro O., Cocozza S., Auciello S., Cigolini M., Pichiri I., Brangani C., Tomasetto E., Sinagra T., Longhitano S., Tropea V., Ballardini G., Babini A. C., Ripani R., Gregori G., Dolci M., Bruselli L., Salutini I., Mori M., Baccetti F., Lapolla A., Sartore G., Burlina S., Chilelli N. C., Buzzetti R., Venditti C., Carlone A., Galluzzo A., Giordano C., Torregrossa V., Corsi L., Cuneo G., Corsi S., Tizio B., Galluzzo G., Citro G., Natale M., Salvatore V., Di Cianni G., Lacaria E., Russo L., Iannarelli R., De Gregorio A., Sciarretta F., D'Andrea S., Montani V., Cannarsa E., Dolcetti K., Cordera R., Bonabello L. A., Mazzucchelli C., Giorda C. B., Bonetto C., Baldassarre M. P. A., Iovine C., Ciano O., Dall'Aglio E., Mancastroppa G., Grimaldi F., Tonutti L., Boemi M., D'Angelo F., Leotta S., Lauro D., Rinaldi M. E., Cignarelli M., La Macchia O., Fariello S., Tomasi F., Zamboni C., Dozio N., Trevisan R., Scaranna C., Del Prato S., Miccoli R., Garofolo M., Pugliese G., Salvi L., Rangel G., Anichini R., Tedeschi A., Corsini E., Cucinotta D., Di Benedetto A., Giunta L., Ruffo M. C., Bossi A. C., Carpinter R., Dotta F., Ceccarelli E., Bartolo P. D., Caselli C., Luberto A., Calbucci G., Consoli A., Ginestra F., Calabrese M., Zogheri A., Laviola L., Ippolito C., Tarantino L., Avogaro A., Carallo C., Scicchitano C., Livraga S., Perin P. C., Forrnengo P., Prinzis T., De Cosmo S., Bacci S., Lamanna C., Lettina G., Aiello A., Lalli C., Franzetti I., Petrachi F., Asprino V., Capra C., Forte E., Reggiani G. M., Forlani G., Montesi L., Mazzella N., Piatti P. M., Monti L., Stuccillo M., Auletta P., Petraroli E., Capobianco G., Romano G., Cutolo M., De Simone G., Caiazzo G., Nunziata P., Sorrentino S., Amelia U., Calatola P., and Capuano G.

Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes.

Published
2018

7. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Author

Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., Agrusta M., Vaccaro, O, Masulli, M, Nicolucci, A, Bonora, E, Del Prato, S, Maggioni, A, Rivellese, A, Squatrito, S, Giorda, C, Sesti, G, Mocarelli, P, Lucisano, G, Sacco, M, Signorini, S, Cappellini, F, Perriello, G, Babini, A, Lapolla, A, Gregori, G, Giordano, C, Corsi, L, Buzzetti, R, Clemente, G, Di Cianni, G, Iannarelli, R, Cordera, R, La Macchia, O, Zamboni, C, Scaranna, C, Boemi, M, Iovine, C, Lauro, D, Leotta, S, Dall'Aglio, E, Cannarsa, E, Tonutti, L, Pugliese, G, Bossi, A, Anichini, R, Dotta, F, Di Benedetto, A, Citro, G, Antenucci, D, Ricci, L, Giorgino, F, Santini, C, Gnasso, A, De Cosmo, S, Zavaroni, D, Vedovato, M, Consoli, A, Calabrese, M, di Bartolo, P, Fornengo, P, Riccardi, G, D'Angelo, F, Giansanti, R, Tanase, L, Lanari, L, Testa, I, Pancani, F, Ranchelli, A, Vagheggi, P, Scatona, A, Fontana, L, Laviola, L, Tarantino, L, Ippolito, C, Gigantelli, V, Manicone, M, Conte, E, Trevisan, R, Rota, R, Dodesini, A, Reggiani, G, Montesi, L, Mazzella, N, Forlani, G, Caselli, C, Di Luzio, R, Mazzotti, A, Aiello, A, Barrea, A, Musto, A, D'Amico, F, Sinagra, T, Longhitano, S, Trowpea, V, Sparti, M, Italia, S, Lisi, E, Grasso, G, Pezzino, V, Insalaco, F, Carallo, C, Scicchitano, C, De Franceschi, M, Calbucci, G, Ripani, R, Cuneo, G, Corsi, S, Romeo, F, Lesina, A, Comoglio, M, Bonetto, C, Robusto, A, Nada, E, Asprino, V, Cetraro, R, Impieri, M, Lucchese, G, Donnarumma, G, Tizio, B, Lenza, L, Paraggio, P, Tomasi, F, Dozio, N, Scalambra, E, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, O, Fariello, S, Sorrentino, M, Franzetti, I, Radin, R, Annunziata, F, Bonabello, L, Durante, A, Dolcino, M, Gallo, F, Mazzucchelli, C, Aleo, A, Melga, P, Briatore, L, Maggi, D, Storace, D, Cecoli, F, D'Ugo, E, Pupillo, M, Baldassarre, M, Salvati, F, Minnucci, A, De Luca, A, Zugaro, A, Santarelli, L, Bosco, A, Petrella, V, La Verghetta, G, D'Andrea, S, Giuliani, A, Polidoro, W, Sperandio, A, Sciarretta, F, Pezzella, A, Carlone, A, Potenziani, S, Venditti, C, Foffi, C, Carbone, S, Cipolloni, L, Moretti, C, Leto, G, Serra, R, Petrachi, F, Romano, I, Lacaria, E, Russo, L, Goretti, C, Sannino, C, Dolci, M, Bruselli, L, Mori, M, Baccetti, F, Del Freo, M, Cucinotta, D, Giunta, L, Ruffo, M, Cannizzaro, D, Pintaudi, B, Perrone, G, Pata, P, Ragonese, F, Lettina, G, Mancuso, T, Coppolino, A, Piatti, P, Monti, L, Stuccillo, M, Lucotti, P, Setola, M, Crippa, G, Loi, C, Oldani, M, Bottalico, M, Pellegata, B, Bonomo, M, Menicatti, L, Resi, V, Bertuzzi, F, Disoteo, E, Pizzi, G, Annuzzi, G, Capaldo, B, Nappo, R, Auciello, S, Turco, A, Costagliola, L, Corte, G, Vallefuoco, P, Nappi, F, Vitale, M, Cocozza, S, Ciano, O, Massimino, E, Garofalo, N, Avogaro, A, Guarneri, G, Fedele, D, Sartore, G, Chilelli, N, Burlina, S, Bonsembiante, B, Galluzzo, A, Torregrossa, V, Mancastroppa, G, Arsenio, L, Cioni, F, Caronna, S, Papi, M, Santeusanio, F, Calagreti, G, Timi, A, Tantucci, A, Marino, C, Ginestra, F, Di Biagio, R, Taraborelli, M, Miccoli, R, Bianchi, C, Garofolo, M, Politi, K, Penno, G, Livraga, S, Calzoni, F, Corsini, E, Tedeschi, A, Gagliano, M, Ippolito, G, Salutini, E, Cervellino, F, Natale, M, Salvatore, V, Zampino, A, Sinisi, R, Arcangeli, A, Zogheri, A, Guizzotti, S, Longo, R, Pellicano, F, Scolozzi, P, Termine, S, Luberto, A, Ballardini, G, Trojani, C, Mazzuca, P, Bruglia, M, Ciamei, M, Genghini, S, Zannoni, C, Rangel, G, Salvi, L, Zappaterreno, A, Cordone, S, Simonelli, P, Meggiorini, M, Frasheri, A, Di Pippo, C, Maglio, C, Mazzitelli, G, Rinaldi, M, Galli, A, Romano, M, D'Angelo, P, Suraci, C, Bacci, S, Palena, A, Genovese, S, Mancino, M, Rondinelli, M, Capone, F, Calabretto, E, Bulgheroni, M, Bucciarelli, L, Ceccarelli, E, Fondelli, C, Santacroce, C, Guarino, E, Nigi, L, Lalli, C, Di Vizia, G, Scarponi, M, Montani, V, Di Bernardino, P, Romagni, P, Dolcetti, K, Forte, E, Tamburo, L, Perin, P, Prinzis, T, Gruden, G, Bruno, G, Zucco, C, Perotta, M, Marena, S, Monsignore, S, Panero, F, Ponzi, F, Carpinteri, R, Casagrande, M, Coletti, M, Balini, A, Filopanti, M, Madaschi, S, Pulcina, A, Grimaldi, F, Venturini, G, Agus, S, Pagnutti, S, Guidotti, F, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Fainelli, G, Tomasetto, E, Zoppini, G, Galletti, A, Perrone, D, Capra, C, Bianchini, F, Ceseri, M, Di Nardo, B, Sasso, E, Bartolomei, B, Suliman, I, Fabbri, G, Romano, G, Maturo, N, Nunziata, G, Capobianco, G, De Simone, G, Villa, V, Rota, G, Pentangelo, C, Carbonara, O, Caiazzo, G, Cutolo, M, Sorrentino, T, Mastrilli, V, Amelia, U, Masi, S, Corigliano, G, Gaeta, I, Armentano, V, Calatola, P, Capuano, G, Angiulli, B, Auletta, P, Petraroli, E, Iodice, C, Agrusta, M, Vaccaro O., Masulli M., Nicolucci A., Bonora E., Del Prato S., Maggioni A. P., Rivellese A. A., Squatrito S., Giorda C. B., Sesti G., Mocarelli P., Lucisano G., Sacco M., Signorini S., Cappellini F., Perriello G., Babini A. C., Lapolla A., Gregori G., Giordano C., Corsi L., Buzzetti R., Clemente G., Di Cianni G., Iannarelli R., Cordera R., La Macchia O., Zamboni C., Scaranna C., Boemi M., Iovine C., Lauro D., Leotta S., Dall'Aglio E., Cannarsa E., Tonutti L., Pugliese G., Bossi A. C., Anichini R., Dotta F., Di Benedetto A., Citro G., Antenucci D., Ricci L., Giorgino F., Santini C., Gnasso A., De Cosmo S., Zavaroni D., Vedovato M., Consoli A., Calabrese M., di Bartolo P., Fornengo P., Riccardi G., D'Angelo F., Giansanti R., Tanase L., Lanari L., Testa I., Pancani F., Ranchelli A., Vagheggi P., Scatona A., Fontana L., Laviola L., Tarantino L., Ippolito C., Gigantelli V., Manicone M., Conte E., Trevisan R., Rota R., Dodesini A. R., Reggiani G. M., Montesi L., Mazzella N., Forlani G., Caselli C., Di Luzio R., Mazzotti A., Aiello A., Barrea A., Musto A., D'Amico F., Sinagra T., Longhitano S., Trowpea V., Sparti M., Italia S., Lisi E., Grasso G., Pezzino V., Insalaco F., Carallo C., Scicchitano C., De Franceschi M. S., Calbucci G., Ripani R., Cuneo G., Corsi S., Romeo F., Lesina A., Comoglio M., Bonetto C., Robusto A., Nada E., Asprino V., Cetraro R., Impieri M., Lucchese G., Donnarumma G., Tizio B., Lenza L., Paraggio P., Tomasi F., Dozio N., Scalambra E., Mannucci E., Lamanna C., Cignarelli M., Macchia O. L., Fariello S., Sorrentino M. R., Franzetti I., Radin R., Annunziata F., Bonabello L. A., Durante A., Dolcino M., Gallo F., Mazzucchelli C., Aleo A., Melga P., Briatore L., Maggi D., Storace D., Cecoli F., D'Ugo E., Pupillo M., Baldassarre M. P. A., Salvati F., Minnucci A., De Luca A., Zugaro A., Santarelli L., Bosco A., Petrella V., La Verghetta G. G., D'Andrea S., Giuliani A. E., Polidoro W. L., Sperandio A., Sciarretta F., Pezzella A., Carlone A., Potenziani S., Venditti C., Foffi C., Carbone S., Cipolloni L., Moretti C., Leto G., Serra R., Petrachi F., Romano I., Lacaria E., Russo L., Goretti C., Sannino C., Dolci M., Bruselli L., Mori M. L., Baccetti F., Del Freo M., Cucinotta D., Giunta L., Ruffo M. C., Cannizzaro D., Pintaudi B., Perrone G., Pata P., Ragonese F., Lettina G., Mancuso T., Coppolino A., Piatti P. M., Monti L., Stuccillo M., Lucotti P., Setola M., Crippa G. V., Loi C., Oldani M., Bottalico M. L., Pellegata B., Bonomo M., Menicatti L. S. M., Resi V., Bertuzzi F., Disoteo E. O., Pizzi G., Annuzzi G., Capaldo B., Nappo R., Auciello S. M., Turco A. A., Costagliola L., Corte G. D., Vallefuoco P., Nappi F., Vitale M., Cocozza S., Ciano O., Massimino E., Garofalo N., Avogaro A., Guarneri G., Fedele D., Sartore G., Chilelli N. C., Burlina S., Bonsembiante B., Galluzzo A., Torregrossa V., Mancastroppa G., Arsenio L., Cioni F., Caronna S., Papi M., Santeusanio F., Calagreti G., Timi A., Tantucci A., Marino C., Ginestra F., Di Biagio R., Taraborelli M., Miccoli R., Bianchi C., Garofolo M., Politi K. S., Penno G., Livraga S., Calzoni F., Mancastroppa G. L. F., Corsini E., Tedeschi A., Gagliano M. S., Ippolito G., Salutini E., Cervellino F., Natale M., Salvatore V., Zampino A., Sinisi R., Arcangeli A., Zogheri A., Guizzotti S., Longo R., Pellicano F., Scolozzi P., Termine S., Luberto A., Ballardini G., Trojani C., Mazzuca P., Bruglia M., Ciamei M., Genghini S., Zannoni C., Rangel G., Salvi L., Zappaterreno A., Cordone S., Simonelli P., Meggiorini M., Frasheri A., Di Pippo C., Maglio C., Mazzitelli G., Rinaldi M. E., Galli A., Romano M., D'Angelo P., Suraci C., Bacci S., Palena A. P., Genovese S., Mancino M., Rondinelli M., Capone F., Calabretto E., Bulgheroni M., Bucciarelli L., Ceccarelli E., Fondelli C., Santacroce C., Guarino E., Nigi L., Lalli C., Di Vizia G., Scarponi M., Montani V., Di Bernardino P., Romagni P., Dolcetti K., Forte E., Tamburo L., Perin P. C., Prinzis T., Gruden G., Bruno G., Zucco C., Perotta M., Marena S., Monsignore S., Panero F., Ponzi F., Carpinteri R., Casagrande M. L., Coletti M. F., Balini A., Filopanti M., Madaschi S., Pulcina A., Grimaldi F., Venturini G., Agus S., Pagnutti S., Guidotti F., Cavarape A., Cigolini M., Pichiri I., Brangani C., Fainelli G., Tomasetto E., Zoppini G., Galletti A., Perrone D., Capra C., Bianchini F., Ceseri M., Di Nardo B., Sasso E., Bartolomei B., Suliman I., Fabbri G., Romano G., Maturo N., Nunziata G., Capobianco G., De Simone G., Villa V., Rota G., Pentangelo C., Carbonara O., Caiazzo G., Cutolo M., Sorrentino T., Mastrilli V., Amelia U., Masi S., Corigliano G., Gaeta I., Armentano V., Calatola P., Capuano G., Angiulli B., Auletta P., Petraroli E., Iodice C. E., and Agrusta M.

Abstract

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50–75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2–3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15–45 mg) or a sulfonylurea (5–15 mg glibenclamide, 2–6 mg glimepiride, or 30–120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 p

Published
2017

8. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial

Author

Vaccaro, O, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, IT study group, T. O. S. C. A., Sud, Cm, Imbaro, S, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, S, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, G, Rizzo, Mr, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, Francesco, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini, M., Vaccaro, O1, Masulli, M, Bonora, E, Del Prato, S, Giorda, Cb, Maggioni, Ap, Mocarelli, P, Nicolucci, A, Rivellese, Aa, Squatrito, S, Riccardi, G, Collaborators Riccardi G, T. O. S. C. A. IT study g. r. o. u. p., Sud, Cm, Imbaro, S, Vaccaro, O, Garofalo, N, Ferrannini, E, Howard, B, Gerdts, E, Imperatore, G, Tavazzi, L, Pellegrini, F, Fabbri, G, Levantesi, G, Turazza, F, Gentile, Sandro, Panico, S, Brambilla, P, Signorini, S, Cappellini, F, Parma, C, D'Alonzo, D, Di Nardo, B, Ferrari, S, Franciosi, M, Pecce, R, Valentini, M, Ceseri, M, Bianchini, F, Baldini, E, Atzori, A, Boemi, M, D'Angelo, F, Giansanti, R, Ricci, L, Ranchelli, A, Di Berardino, P, Cannarsa, E, Giorgino, F, Manicone, M, Tarantino, L, Trevisan, R, Scaranna, C, Forlani, G, Montesi, L, Aiello, A, Barrea, A, Sinagra, T, Longhitano, S, Sesti, G, Gnasso, A, Carallo, C, Scicchitano, C, Santini, C, Calbucci, G, Ripani, R, Corsi, L, Corsi, S, Romeo, F, Asprino, V, Donnarumma, G, Tizio, B, Clemente, G, Tomasi, F, Dozio, N, Mannucci, E, Lamanna, C, Cignarelli, M, Macchia, Ol, Fariello, S, Cordera, R, Mazzucchelli, C, Pupillo, M, Zugaro, A, Bosco, A, De Luca, A, Iannarelli, R, Giuliani, A, Polidoro, L, Sperandio, A, Sciarretta, F, Raffaella, B, Venditti, C, Di Cianni, G, Goretti, C, Dolci, Ma, Bruselli, L, Mori, M, Baccetti, F, Gregori, G, Venezia, A, Cucinotta, D, Pintaudi, B, Ragonese, F, Pata, P, Piatti, Pm, Luccotti, P, Orsi, E, Bonomo, M, Menicatti, L, Turco, Aa, Ciano, O, Vallefuoco, P, Corigliano, G, Pentangelo, C, Petraroli, E, Auletta, P, Carbonara, O, Capobianco, G, Caiazzo, G, Angiulli, B, De Simone, G, Michele, C, Mastrilli, V, Nunziata, G, Romano, G, Gaeta, I, Sorrentino, T, Iovine, C, Nappi, F, Paolisso, Giuseppe, Rizzo, Maria Rosaria, Avogaro, A, Vedovato, M, Lapolla, A, Sartore, G, Burlina, S, Chilelli, Nc, Galluzzoy, A, Giordano, C, Torregrossa, V, Arsenio, L, Dall'Aglio, E, Cioni, F, Babini, M, Moncastroppa, G, Perriello, G, Timi, A, Consoli, A, Ginestra, F, Zavaroni, D, Calzoni, F, Miccoli, R, Bianchi, C, Politi, S, Anichini, R, Tedeschi, A, Citro, G, Zampino, A, Rosa, S, Natale, M, Giocoli, Cl, Caruso, E, Tramontano, L, Imbroinise, A, Perna, Cd, Calabrese, M, Zogheri, A, Luberto, A, Ballardini, G, Babini, Ac, Zannoni, C, Pugliese, G, Salvi, L, Mazzitelli, G, Zappaterreno, A, Frontoni, S, Ventricini, A, Lauro, D, Galli, A, Rinaldi, Me, Leotta, S, Fontana, L, Goretti, S, Pozzilli, P, Leonetti, F, Morano, S, Filetti, S, Cosmo, Sd, Bacci, S, Palena, Ap, Calatola, P, Capuano, G, Amelia, U, Dotta, F, Guarino, E, Ceccarelli, E, Lalli, C, Scarponi, M, Forte, E, Potenziani, S, Perin, Pc, Marena, S, Zucco, C, Perotto, M, Bossi, A, Filopanti, M, Grimaldi, F, Tonutti, L, Cavarape, A, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Capra, C, Cigolini M., Author information, Vaccaro, Olga, Masulli, Maria, Rivellese, ANGELA ALBAROSA, Riccardi, Gabriele, Giorda, C, Maggioni, A, Rivellese, A, Giorda, CB, Maggioni, AP, and Rivellese, AA

Subjects
Blood Glucose, Male, BIO/12 - BIOCHIMICA CLINICA E BIOLOGIA MOLECOLARE CLINICA, Endocrinology, Diabetes and Metabolism, pioglitazone, sulfonylurea, type 2 diabetes, metformin, cardiovascular events, Medicine (miscellaneous), Type 2 diabetes, Settore MED/13 - Endocrinologia, Body Mass Index, law.invention, Randomized controlled trial, Risk Factors, law, Surveys and Questionnaires, Cardiovascular Disease, pioglitazone, piogllitazone, Stroke, Diabetes, Therapy, Pioglitazone, Nutrition and Dietetics, Diabetes, Thiazolidinedione, cardiovascular events, Type 2 Diabetes Mellitus, sulphonylureas, Middle Aged, Metformin, Sulfonylurea Compound, Treatment Outcome, Tolerability, Cardiovascular Diseases, Drug Therapy, Combination, Female, type 2 diabetes, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Endpoint Determination, sulfonylurea, cardiovascualr event, Sudden death, Follow-Up Studie, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, sulfonylureas, interventio trial, randomized controlled trial, Aged, Hypoglycemic Agent, Questionnaire, business.industry, Risk Factor, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Quality of Life, Thiazolidinediones, Therapy, business, metformin, Pioglitazone, Follow-Up Studies
Abstract

Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50–75 years, BMI 20–45 Kg/m 2 , on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. Conclusions TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Registration: Clinicaltrials.gov ID NCT00700856.

Published
2012

9. Time course analysis of brachial artery flow mediated dilatation in subjects with gingival inflammation

Author

Carallo, C., Irace, C., Tripolino, C., Franceschi, M. S., Procopio, A., Crispino, A., leonzio Fortunato, and Gnasso, A.

Subjects
Male, Vasodilation, Time Factors, Brachial Artery, Statistics as Topic, Humans, Female, Endothelium, Vascular, Middle Aged, Gingivitis, Aged, Ultrasonography
Abstract

Several investigations report an inverse association between periodontal disease and endothelial function measured by brachial artery Flow-Mediated-Dilatation (FMD) technique. These studies examined endothelial function by using the traditional approach to FMD calculation, that is from diameters assessed at 60 seconds after deflation. Nevertheless, possible relationship between gingival inflammation and endothelial dysfunction observed over this temporal threshold remains still unexplored. The purpose of our study was to explore the relationship between gingival inflammation and endothelial function, by considering the time course of brachial FMD.Forty-six free-living white subjects, participating in a cardiovascular disease prevention campaign, were enrolled. FMD was measured at 60s and at 2 and 3 min after forearm ischemia. Maximal FMD was calculated (Peak FMD), for each patient. Gingival Index (GI) was evaluated as measure of gingival inflammation.In univariate analyses, GI was associated with both FMD at 60 sec (r=-0.30, P=0.038) and Peak FMD (r=-0.41, P=0.004). In multiple regression analyses including GI, age, gender, and known risk factors for atherosclerosis, only GI and age were independently and inversely associated with Peak FMD and FMD at 60 s, but this association was stronger with Peak FMD. Moreover, when we divided subjects on the basis of GI value, patients with GI1 presented lower Peak FMD and higher prevalence of absent FMD.The present study extends previous observations about the negative effects of periodontal disease on endothelial function, highlighting the importance of the evaluation of time course of vascular reactivity.

Published
2014

10. Prehistoric ceramics as recorders of the earth's magnetic field intensity : case studies from North-Central Greece and a multidisciplinary approach for material selection

Author

Kondopoulou, D., Gomez Paccard, Miriam, Aidona, E., Rathossi, C., Carallo, C., Tema, E., School of Geology [Thessaloniki], Aristotle University of Thessaloniki, Géosciences Rennes (GR), Université de Rennes (UR)-Institut national des sciences de l'Univers (INSU - CNRS)-Observatoire des Sciences de l'Univers de Rennes (OSUR), Université de Rennes (UR)-Institut national des sciences de l'Univers (INSU - CNRS)-Université de Rennes 2 (UR2)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut national des sciences de l'Univers (INSU - CNRS)-Université de Rennes 2 (UR2)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Observatoire des Sciences de l'Univers de Rennes (OSUR)-Institut national des sciences de l'Univers (INSU - CNRS)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), and Dubigeon, Isabelle

Subjects
[SDU.STU] Sciences of the Universe [physics]/Earth Sciences, [SDU.STU]Sciences of the Universe [physics]/Earth Sciences, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2014

11. Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial

Author

Bosi, E, Scavini, M, Ceriello, A, Cucinotta, D, Tiengo, A, Marino, R, Bonizzoni, E, Giorgino, F, on behalf of the PRISMA Study Group, Trevisan, R, Dodesini, Ar, Corsi, A, Sciangula, L, Ciucci, A, Olivo, Es, Tonutti, L, Boscariol, C, Armellini, M, Pozzilli, P, Maurizi, Ar, Manfrini, S, Napoli, N, Tuccinardi, D, Ghirlanda, G, Gagliardi, L, Ranalli, L, Zaccuri, S, Giorgianni, L, Guarnieri, G, Di Bartolo, P, Pellicano, F, Scolozzi, P, Leotta, S, Fontana, L, Tonolo, G, Cherchi, S, Canu, L, Foglini, P, Maricotti, R, Tortato, E, Pianti, C, Madaschi, S, Tortul, C, Da Ros, R, Muraro, R, Ansaldi, E, Cacciola, S, Cignarelli, M, Lamacchia, O, Nizzoli, M, Buci, L, Calatola, P, Clemente, G, Caputo, A, Mollo, F, Friogato, G, Rampini, A, Morpurgo, P, Bonino, G, Vita, Mg, Laviola, L, Gnasso, A, Carallo, C, Calabria, M, Beltramello, G, Marangoni, A, Cattaneo, A, Guido, R, Massidda, A, Meloni, G, Bonomo, Ma, Pizzi, G, Camerini, M, Provenzano, V, Ferrara, L, Provenzano, F, Paccagnella, A, Sambataro, M, Almoto, B, Baroni, Mg, Cossu, E, Zedde, A, Consoli, A, Di Fulvio, P, Dotta, Francesco, Guarino, E, Annuzzi, G, Bozzeto, L, Cicioni, G, Calabrese, M, Guizzotti, S, Cabasino, F, Farci, F, Ghiani, M, Tubili, C, Nardone, Mr, Candido, R, Tommasi, E, Jagodnik, G, Strazzabosco, M, Mesturino, Ca, Santeusanio, F, Torlone, E, and Annone, S.

Published
2013

12. Intensive structured self-monitoring of blood glucose and glycemic control in noninsulin-treated type 2 diabetes: The PRISMA randomized trial

Author

Bosi, E., Scavini, M., Ceriello, A., Cucinotta, D., Tiengo, A., Marino, R., Bonizzoni, E., Giorgino, F., Group Collaborators: Trevisan, Prisma Study R., Dodesini, A. R., Corsi, A., Sciangula, L., Ciucci, A., Olivo, E. S., Tonutti, L., Boscariol, C., Armellini, M., Pozzilli, P., Maurizi, A. R., Manfrini, S., Napoli, N., Tuccinardi, D., Ghirlanda, G., Gagliardi, L., Ranalli, L., Zaccuri, S., Giorgianni, L., Guarnieri, G., Di Bartolo, P., Pellicano, F., Scolozzi, P., Leotta, S., Fontana, L., Tonolo, G., Cherchi, S., Canu, L., Foglini, P., Maricotti, R., Tortato, E., Pianti, C., Madaschi, S., Tortul, C., Da Ros, R., Muraro, R., Ansaldi, E., Cacciola, S., Cignarelli, M., Lamacchia, O., Nizzoli, M., Buci, L., Calatola, P., Clemente, G., Caputo, A., Mollo, F., Friogato, G., Rampini, A., Morpurgo, P., Bonino, G., Vita, M. G., Laviola, L., Gnasso, A., Carallo, C., Calabria, M., Beltramello, G., Marangoni, A., Cattaneo, A., Guido, R., Massidda, A., Meloni, G., Bonomo, M. A., Pizzi, G., Camerini, M., Provenzano, V., Ferrara, L., Provenzano, F., Paccagnella, A., Sambataro, M., Almoto, B., Baroni, Marco Giorgio, Cossu, E., Zedde, A., Consoli, A., Di Fulvio, P., Dotta, Francesco, Guarino, E., Annuzzi, G., Bozzeto, L., Cicioni, G., Calabrese, M., Guizzotti, S., Cabasino, F., Farci, F., Ghiani, M., Tubili, C., Nardone, M. R., Candido, R., Tommasi, E., Jagodnik, G., Strazzabosco, M., Mesturino, C. A., Santeusanio, F., Torlone, E., and Annone, S.

Published
2013

13. Endothelial dysfunction or dysfunctions? Identification of three different FMD responses in males with type 2 diabetes

Author

Irace, C, Tschakovsky, M, Carallo, C, Cortese, C, and Gnasso, A

Subjects
Adult, Male, type2 diabetes, Settore MED/09 - Medicina Interna, Models, Statistical, Time Factors, Brachial Artery, Settore BIO/12, Middle Aged, atherosclerosis,endothelial function,type2 diabetes, Cohort Studies, Vasodilation, endothelial function, Diabetes Mellitus, Type 2, Humans, Endothelium, Vascular, Stress, Mechanical, Vascular Diseases, atherosclerosis, Aged, Ultrasonography
Abstract

Endothelial function is widely evaluated by vasodilatation of the brachial artery induced by ischemia (flow-mediated vasodilatation, FMD). The function of the endothelium, in this setting, is to sense wall shear stress (WSS) increase and to release vasodilators. Following current guidelines FMD is measured 50-60s after ischemia. It is not known whether this lapse of time is sufficient to observe maximal vasodilatation, especially in diseased subjects. Sixty-six subjects with type 2 diabetes and 30 controls underwent FMD-test. Brachial artery WSS was measured at rest and during the first 15s after ischemia as index of peripheral resistances vessels reactivity, and FMD at 50, 120, 180, and 300s after ischemia as index of conduit vessel function. All controls exhibited increased WSS and peak FMD at 50s. Among subjects with diabetes three groups were identified based on the time at which peak FMD occurred. Twenty subjects with diabetes exhibited peak at 50s (Early FMD), 28 at 2 min (Late FMD), and 18 showed no FMD (Absent FMD). Peak FMD in Late FMD subgroup was comparable to peak in control subjects and significantly higher than peak in other subjects with diabetes. The "Absent FMD" group showed also impaired WSS. The present findings demonstrate that brachial artery response to ischemia is heterogeneous in type 2 diabetes, suggesting different mechanisms responsible for FMD alteration in this condition.

Published
2007

26. Modulating the vascular behavior of metastatic breast cancer cells by curcumin treatment.

Author

Palange, A. L., Di Mascolo, D., Singh, J., De Franceschi, M. S., Carallo, C., Gnasso, A., and Decuzzi, P.

Subjects
BREAST cancer treatment, METASTASIS, CANCER cells, BLOOD vessels, CURCUMIN
Abstract

The spreading of tumor cells to secondary sites (tumor metastasis) is a complex process that involves multiple, sequential steps. Vascular adhesion and extravasation of circulating tumor cells (CTCs) is one, critical step. Curcumin, a natural compound extracted from Curcuma longa, is known to have anti-tumoral, anti-proliferative, anti-inflammatory properties and affect the expression of cell adhesion molecules, mostly by targeting the NF-κB transcription factor. Here, upon treatment with Curcumin, the vascular behavior of three different estrogen receptor negative (ER-) breast adenocarcinoma cell lines (SK-BR-3, MDA-MB-231, MDA-MB-468) is analyzed using a microfluidic system. First, the dose response to curcumin is characterized at 24, 48 and 72h using a XTT assay. For all three cell lines, an IC50 larger than 20 μM is observed at 72 h; whereas no significant reduction in cell viability is detected for curcumin concentrations up to 10 μM. Upon 24 h treatment at 10 μM of curcumin, SK-BR3 and MDA-MB-231 cells show a decrease in adhesion propensity of 40% (p = 0.02) and 47% (p = 0.001), respectively. No significant change is documented for the less metastatic MDA-MB-468 cells. All three treated cell lines show a 20% increase in rolling velocity from 48.3 to 58.7 μm/s in SK-BR-3, from 64.1 to 73.77 μm/s in MDAMB-231 and from 57.5 to 74.4 μm/s in MDA-MB-468. Collectively, these results suggest that mild curcumin treatments could limit the metastatic potential of these adenocarcinoma cell lines, possibly by altering the expression of adhesion molecules, and the organization and stiffness of the cell cytoskeleton. Future studies will elucidate the biophysical mechanisms regulating this curcumin-induced behavior and further explore the clinical relevance of these findings. [ABSTRACT FROM AUTHOR]

Published
2012
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27. Hepatic steatosis, carotid atherosclerosis and metabolic syndrome: the STEATO Study.

Author

Carallo C, Mancuso G, Mauro G, Laghi F, Madafferi B, Irace C, Gnasso A, Scavelli F, Dell'Aquila F, Bartone M, Gullo F, Ferraro M, Spagnuolo V, Belmonte M, Ferrara A, Silvano Rotondaro A, Brandolino N, Parasporo F, Scopelliti F, and Carallo, Claudio

Abstract

Purpose: Hepatic steatosis is frequently observed in subjects with metabolic syndrome (MS). In type 2 diabetics, it is independently associated with cardiovascular diseases. In order to confirm and extend this finding, a large group of patients with risk factors for atherosclerosis was studied.Methods: Carotid atherosclerosis was investigated by echo-Doppler, and hepatic steatosis by ultrasound and transaminase values. Strict exclusion criteria were chosen in order to avoid secondary forms of fatty liver and interference on transaminase values.Results: Among 970 enrolled patients, about 20% were diabetics, half had MS and 76% presented echographic hepatic steatosis. In multivariate analyses, fatty liver and MS were associated with carotid atherosclerosis [odds ratio (95% confidence intervals) 2.15 (1.27-3.63) and 1.72(1.12-2.64), respectively], whereas HOMA index was not. Aspartate aminotransferase and alanine aminotransferase were not independently associated with carotid atherosclerosis, whereas gamma-glutamyl transferase showed a link with atherosclerosis beyond MS and steatosis presence. The analyses of the 780 non diabetics recruited showed similar results.Conclusions: The results of the present study demonstrate that hepatic steatosis measured by echography is associated with carotid atherosclerosis in a large population mostly carrying cardiovascular or metabolic risk factors, independently of MS, cardiovascular diseases, diabetes mellitus and/or insulin resistance. [ABSTRACT FROM AUTHOR]

Published
2009
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31. Blood urea impairs brachial artery flow mediated dilation

Author

Tripolino, C., Irace, C., Carallo, C., Franceschi, M. S., Elisabetta DELLA VALLE, Gnasso, A., Tripolino, C, Irace, C, Carallo, C, De Franceschi, M, DELLA VALLE, Elisabetta, and Gnasso, A.

Subjects
Adult, Male, Brachial Artery, Cholesterol, HDL, Middle Aged, Vasodilation, Cross-Sectional Studies, Risk Factors, Creatinine, Humans, Kidney Failure, Chronic, Regression Analysis, Urea, Female, Endothelium, Vascular, Biomarkers, Aged, Glomerular Filtration Rate
Abstract

Urea, the main product of protein catabolism, is a biochemical marker of renal function. Though it is known that serum urea impairs vascular health, the relationship between its concentration and vascular reactivity in vivo has not been explored. Our study was undertaken to investigate possible association between serum urea and endothelial function in subjects without chronic kidney disease (CKD).Eighty free-living subjects with serum creatinine ≤1 mg/dL and without CKD were enrolled for the present study. Serum analyses and evaluation of endothelial function were performed in all subjects. Endothelial function was measured using the flow-mediated dilation (FMD) technique. Simple and multiple regression analyses were used to test the association between FMD and considered variables.In correlation analyses FMD was found directly associated with HDL cholesterol (r=0.21; P=0.05) and eGFR (r=0.25; P=0.02) and inversely associated with age (r=-0.26; P=0.02), serum urea (r=-0.37; P0.01), serum creatinine (r=-0.31; P0.01) and brachial artery baseline diameter (r=-0.41; P0.01). In multiple regression analysis only baseline artery diameter and serum urea predicted FMD; age, gender and cardiovascular risk factors did not relate with FMD.Our study demonstrates the association between serum urea and FMD, suggesting that the accumulation of waste products of protein metabolism may impair vascular health in subjects without CKD.

34. Delayed flow-mediated vasodilation and critical coronary stenosis

Author

Concetta Irace, Salvatore De Rosa, Cesare Tripolino, Giuseppe Ambrosio, Caterina Covello, Ennio Abramo, Claudio Carallo, Annalisa Mongiardo, Carmen Spaccarotella, Daniele Torella, Agostino Gnasso, Ciro Indolfi, Irace, C., De Rosa, S., Tripolino, C., Ambrosio, G., Covello, C., Abramo, E., Carallo, C., Mongiardo, A., Spaccarotella, C., Torella, D., Gnasso, A., and Indolfi, C.

Subjects
Carotid Arterie, Adult, Male, medicine.medical_specialty, coronary stenosi, Logistic Model, Ischemia, brachial artery, Femoral artery, Coronary stenosis, 030204 cardiovascular system & hematology, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Peripheral Arterial Disease, 0302 clinical medicine, Internal medicine, medicine.artery, medicine, Prevalence, Humans, Endothelial dysfunction, Brachial artery, Multivariate Analysi, Coronary atherosclerosis, flow mediated dilation, Aged, Aged, 80 and over, business.industry, Ultrasound, Coronary Stenosis, General Medicine, Middle Aged, medicine.disease, Vasodilation, Carotid Arteries, Logistic Models, Hemorheology, Multivariate Analysis, Cardiology, Female, coronary angiography, business, 030217 neurology & neurosurgery, Flow-Mediated Vasodilation, Human
Abstract

Endothelial dysfunction, wall thickening and plaque are progressive manifestations of atherosclerosis. Delayed or absent brachial artery dilation after ischemic stimulus has been associated with severity of extracoronary and coronary atherosclerosis. In the current study, we aimed to verify if delayed or absent dilation associates with critical coronary stenosis. We also evaluated the association between coronary stenosis, carotid artery wall thickness and peripheral artery disease. Endothelial function was investigated by flow-mediated dilation of the brachial artery up to 3 min after ischemia, and patients classified as early, late or no dilators. Coronary angiography was performed through transradial or femoral artery approach. Computerized quantitative angiography was used to obtain percent stenosis of all lesions, while the Gensini score was used to evaluate the severity of coronary atherosclerosis. Seventy-four patients were enrolled. Carotid wall thickness and plaque, and peripheral artery disease were detected by ultrasound. Subjects with critical coronary stenosis showed a higher prevalence of delayed or absent dilation (coronary stenosis ≥70 per cent: late dilators 50 per cent, no dilators 35 per cent; coronary stenosis ≤70 per cent: late dilators 27 per cent, no dilators 6 per cent). The Gensini score was progressively higher in late dilators and no dilators compared with early dilators (early: 4.5±13.5; late 17.5±27.1; no 39.7±55.0; P

Published
2018

35. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

Author

Vitale, M., Masulli, M., Rivellese, A. A., Bonora, E., Cappellini, F., Nicolucci, Andrea, Squatrito, S., Antenucci, D., Barrea, A., Bianchi, C., Bianchini, F., Fontana, L., Fornengo, P., Giorgino, F., Gnasso, A., Mannucci, E., Mazzotti, A., Nappo, R., Palena, A. P., Pata, P., Perriello, G., Potenziani, S., Radin, R., Ricci, L., Romeo, F., Santini, C., Scarponi, M., Serra, Riccardo, Timi, A., Turco, A. A., Vedovato, M., Zavaroni, D., Grioni, S., Riccardi, G., Vaccaro, O., Rivellese, Angela Albarosa, Cocozza, Sara, Auciello, Stefania, Turco, Anna Amelia, Bonora, Enzo, Cigolini, Massimo, Pichiri, Isabella, Brangani, Corinna, Tomasetto, Elena, Perriello, Gabriele, Timi, Alessia, Squatrito, Sebastiano, Sinagra, Tiziana, Longhitano, Sara, Tropea, Vanessa, Ballardini, Giorgio, Babini, Anna Carla, Ripani, Raffaella, Gregori, Giovanna, Dolci, Maria, Bruselli, Laura, Salutini, Isabella, Mori, Mary, Baccetti, Fabio, Lapolla, Annunziata, Sartore, Giovanni, Burlina, Silvia, Chilelli, Nino Cristiano, Buzzetti, Raffaella, Venditti, Chiara, Potenziani, Stella, Carlone, Angela, Galluzzoâ€&nbsp, Aldo, Giordano, Carla, Torregrossa, Vittoria, Corsi, Laura, Cuneo, Giacomo, Corsi, Simona, Tizio, Biagio, Clemente, Gennaro, Citro, Giuseppe, Natale, Maria, Salvatore, Vita, Di Cianni, Graziano, Lacaria, Emilia, Russo, Laura, Iannarelli, Rossella, de Gregorio, Antonella, Sciarretta, Filomena, D’Andrea, Settimio, Montani, Valeria, Cannarsa, Emanuela, Dolcetti, Katia, Cordera, Renzo, Bonabello, Laura Affinito, Mazzucchelli, Chiara, Giorda, Carlo Bruno, Romeo, Francesco, Bonetto, Caterina, Antenucci, Daniela, Baldassarre, Maria Pompea Antonia, Iovine, Ciro, Nappo, Rossella, Ciano, Ornella, Dall’Aglio, Elisabetta, Mancastroppa, Giovanni, Grimaldi, Franco, Tonutti, Laura, Boemi, Massimo, D’Angelo, Federica, Leotta, Sergio, Fontana, Lucia, Lauro, Davide, Rinaldi, Maria Elena, Cignarelli, Mauro, la Macchia, Olga, Fariello, Stefania, Tomasi, Franco, Zamboni, Chiara, Dozio, Nicoletta, Trevisan, Roberto, Scaranna, Cristiana, Del Prato, Stefano, Miccoli, Roberto, Bianchi, Cristina, Garofolo, Monia, Pugliese, Giuseppe, Salvi, Laura, Rangel, Graziela, Vitale, Martina, Anichini, Roberto, Tedeschi, Anna, Corsini, Elisa, Cucinotta, Domenico, Di Benedetto, Antonino, Giunta, Loretta, Ruffo, Maria Concetta, Bossi, Antonio Carlo, Carpinter, Rita, Dotta, Francesco, Ceccarelli, Elena, Bartolo, Paolo Di, Caselli, Chiara, Luberto, Alessandra, Santini, Costanza, Mazzotti, Arianna, Calbucci, Giovanni, Consoli, Agostino, Ginestra, Federica, Calabrese, Maria, Zogheri, Alessia, Ricci, Lucia, Giorgino, Francesco, Laviola, Luigi, Ippolito, Claudia, Tarantino, Lucia, Avogaro, Angelo, Vedovato, Monica, Gnasso, Agostino, Carallo, Claudio, Scicchitano, Caterina, Zavaroni, Donatella, Livraga, Stefania, Perin, Paolo Cavallo, Forrnengo, Paolo, Prinzis, Tania, de Cosmo, Salvatore, Palena, Antonio Pio, Bacci, Simonetta, Mannucci, Edoardo, Lamanna, Caterina, Pata, Pietro, Lettina, Gabriele, Aiello, Antimo, Barrea, Angelina, Lalli, Carlo, Scarponi, Maura, Franzetti, Ivano, Radin, Raffaella, Serra, Rosalia, Petrachi, Francesca, Asprino, Vincenzo, Capra, Claudio, Forte, Elisa, Reggiani, Giulio Marchesini, Forlani, Gabriele, Montesi, Luca, Mazzella, Natalia, Piatti, Pier Marco, Monti, Lucilla, Stuccillo, Michela, Auletta, Pasquale, Petraroli, Ettore, Capobianco, Giuseppe, Romano, Geremia, Cutolo, Michele, de Simone, Giosetta, Caiazzo, Gennaro, Nunziata, Peppe, Sorrentino, Susy, Amelia, Umberto, Calatola, Pasqualino, Capuano, Gelsomina, Vitale, M, Masulli, M, Rivellese, AA, Bonora, E, Cappellini, F, Nicolucci, A, Squatrito, S, Antenucci, D, Barrea, A, Bianchi, C, Bianchini, F, Fontana, L, Fornengo,P, Giorgino, F, Gnasso, A, Mannucci, Mazzotti, A, Nappo, R, Palena, AP, Pata, P,Perriello, G, Potenziani, S, Radin, R, Ricci, L, Romeo, F, Santini, C, Scarponi, M, Serra, R, Timi, A, Turco, AA, Vedovato, M, Zavaroni, D, Grioni, S, Riccardi, G, Vaccaro, O, TOSCA.IT Study Group., Giordano, C., Rivellese, Aa, Fornengo, P, Mannucci, E, Mazzotti, A, Nappo, R, Palena, Ap, Pata, P, Perriello, G, Turco, Aa, Tosc, A. IT Study Group., Rivellese, A, Palena, A, Turco, A, Cocozza, S, Auciello, S, Cigolini, M, Pichiri, I, Brangani, C, Tomasetto, E, Sinagra, T, Longhitano, S, Tropea, V, Ballardini, G, Babini, A, Ripani, R, Gregori, G, Dolci, M, Bruselli, L, Salutini, I, Mori, M, Baccetti, F, Lapolla, A, Sartore, G, Burlina, S, Chilelli, N, Buzzetti, R, Venditti, C, Carlone, A, Galluzzo, A, Giordano, C, Torregrossa, V, Corsi, L, Cuneo, G, Corsi, S, Tizio, B, Galluzzo, G, Citro, G, Natale, M, Salvatore, V, Di Cianni, G, Lacaria, E, Russo, L, Iannarelli, R, De Gregorio, A, Sciarretta, F, D'Andrea, S, Montani, V, Cannarsa, E, Dolcetti, K, Cordera, R, Bonabello, L, Mazzucchelli, C, Giorda, C, Bonetto, C, Baldassarre, M, Iovine, C, Ciano, O, Dall'Aglio, E, Mancastroppa, G, Grimaldi, F, Tonutti, L, Boemi, M, D'Angelo, F, Leotta, S, Lauro, D, Rinaldi, M, Cignarelli, M, La Macchia, O, Fariello, S, Tomasi, F, Zamboni, C, Dozio, N, Trevisan, R, Scaranna, C, Del Prato, S, Miccoli, R, Garofolo, M, Pugliese, G, Salvi, L, Rangel, G, Anichini, R, Tedeschi, A, Corsini, E, Cucinotta, D, Di Benedetto, A, Giunta, L, Ruffo, M, Bossi, A, Carpinter, R, Dotta, F, Ceccarelli, E, Bartolo, P, Caselli, C, Luberto, A, Calbucci, G, Consoli, A, Ginestra, F, Calabrese, M, Zogheri, A, Laviola, L, Ippolito, C, Tarantino, L, Avogaro, A, Carallo, C, Scicchitano, C, Livraga, S, Perin, P, Forrnengo, P, Prinzis, T, De Cosmo, S, Bacci, S, Lamanna, C, Lettina, G, Aiello, A, Lalli, C, Franzetti, I, Petrachi, F, Asprino, V, Capra, C, Forte, E, Reggiani, G, Forlani, G, Montesi, L, Mazzella, N, Piatti, P, Monti, L, Stuccillo, M, Auletta, P, Petraroli, E, Capobianco, G, Romano, G, Cutolo, M, De Simone, G, Caiazzo, G, Nunziata, P, Sorrentino, S, Amelia, U, Calatola, P, and Capuano, G

Subjects
0301 basic medicine, Male, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Aged, Antioxidants, Beverages, Cinnamates, Cohort Studies, Cross-Sectional Studies, Databases, Factual, Diabetes Mellitus, Type 2, Female, Flavonoids, Fruit, Glycosides, Humans, Italy, Male, Middle Aged, Nutritive Value, Phenols, Polyphenols, Diet, Diabetic, Diet, Healthy, Patient Compliance, Settore MED/09 - Medicina Interna, Databases, Factual, Cross-sectional study, Medicine (miscellaneous), Type 2 diabetes, Diabete, Antioxidants, Settore MED/13 - Endocrinologia, Food group, Cohort Studies, 0302 clinical medicine, Diet, Diabetic, Medicine, Food science, Glycosides, Age, BMI, Diabetes, Diet, Flavonoids, Food groups, Geographical area, Intake, Phenolic acids, Polyphenols, TOSCA.IT study, Nutrition and Dietetics, Phenolic acid, food and beverages, Middle Aged, Polyphenols, Flavonoids, Phenolic acids, Diabetes, Food groups, Diet, Age, BMI, Geographical area, Intake, TOSCA.IT study, Italy, Tosca,Age,BMI,Diabetes,Diet,Flavonoids,Food groups,Geographical area,Intake,Phenolic acids,Polyphenols,TOSCA.IT study, Cohort, Female, Diet, Healthy, Nutritive Value, Cohort study, Polyphenol, 030209 endocrinology & metabolism, Beverages, 03 medical and health sciences, Phenols, Diabetes mellitus, Humans, Aged, 030109 nutrition & dietetics, business.industry, Anthropometry, medicine.disease, Tosca, Cross-Sectional Studies, Diabetes Mellitus, Type 2, Cinnamates, Fruit, Flavonoid, Patient Compliance, business
Abstract

Purpose: Proper evaluation of polyphenols intake at the population level is a necessary step in order to establish possible associations with health outcomes. Available data are limited, and so far no study has been performed in people with diabetes. The aim of this work was to document the intake of polyphenols and their major food sources in a cohort of people with type 2 diabetes and in socio-demographic subgroups. Methods: We studied 2573 men and women aged 50–75 years. Among others, anthropometry was measured by standard protocol and dietary habits were investigated by food frequency questionnaire (EPIC). The intake of polyphenols was evaluated using US Department of Agriculture and Phenol-Explorer databases. Results: The mean total polyphenol intake was 683.3 ± 5.8 mg/day. Non-alcoholic beverages represented the main food source of dietary polyphenols and provided 35.5% of total polyphenol intake, followed by fruits (23.0%), alcoholic beverages (14.0%), vegetables (12.4%), cereal products and tubers (4.6%), legumes (3.7%) and oils (2.1%); chocolate, cakes and nuts are negligible sources of polyphenols in this cohort. The two most important polyphenol classes contributing to the total intake were flavonoids (47.5%) and phenolic acids (47.4%). Polyphenol intake increased with age and education level and decreased with BMI; furthermore, in the northern regions of Italy, the polyphenol intake was slightly, but significantly higher than in the central or southern regions. Conclusions: The study documents for the first time the intake of polyphenols and their main food sources in people with diabetes using validated and complete databases of the polyphenol content of food. Compared with published data, collected in people without diabetes, these results suggest a lower intake and a different pattern of intake in people with diabetes. © 2016 Springer-Verlag Berlin Heidelberg

Published
2016
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36. Components of the metabolic syndrome and carotid atherosclerosis: role of elevated blood pressure

Author

Concetta Irace, Agostino Gnasso, Eduardo Farinaro, Claudio Cortese, Claudio Carallo, Giorgio Sesti, Elio Fiaschi, Irace, C, Cortese, C, Fiaschi, E, Carallo, C, Sesti, G, Farinaro, Eduardo, and Gnasso, A.

Subjects
Adult, Carotid Artery Diseases, Male, medicine.medical_specialty, Waist, Blood Pressure, Elevated blood, chemistry.chemical_compound, Age Distribution, Internal medicine, Internal Medicine, medicine, atherosclerosis carotid arteries hypertension, Prevalence, Humans, Risk factor, Aged, Aged, 80 and over, Metabolic Syndrome, Cholesterol, Vascular disease, business.industry, Smoking, Middle Aged, medicine.disease, Intracranial Arteriosclerosis, Blood pressure, Endocrinology, chemistry, Hypertension, Cardiology, Linear Models, Female, Metabolic syndrome, business, Lipoprotein
Abstract

Elevated blood pressure is among the factors that contribute to the metabolic syndrome (MetS). It is not known whether subjects with MetS and elevated blood pressure are at the same cardiovascular risk as subjects with MetS but without elevated blood pressure. To clarify this point, we have evaluated the prevalence of carotid atherosclerosis in subjects with MetS with or without elevated blood pressure. A large population was examined (842 women and 1011 men). Blood pressure, lipids, glucose, and waist were measured by routine methods. Carotid atherosclerosis was evaluated by echo Doppler examination. The prevalence of MetS was 24.4% in women and 28.7% in men. The prevalence of carotid atherosclerosis was 35.1% in women and 37.3% in men ( p =NS), and increased with increasing number of MetS components. Age, smoking, and systolic blood pressure (SBP) were associated with the presence of carotid atherosclerosis (logistic model), whereas age, high-density lipoprotein cholesterol, and SBP were associated with the extent of atherosclerosis (linear model). When comparing subjects with an equal number of MetS components, the prevalence of carotid atherosclerosis was significantly higher in subjects with elevated blood pressure than in those without. No difference in carotid atherosclerosis prevalence was found in subjects bearing or not bearing components of the syndrome other than elevated blood pressure. The present findings demonstrate that subjects with MetS and elevated blood pressure have increased carotid atherosclerosis compared with subjects with MetS but without elevated blood pressure. The diagnosis of MetS per se might not adequately identify subjects at elevated cardiovascular risk.

Published
2005

37. Intimal plus media thickness of common carotid arterial wall in subjects with hypertension

Author

Pujia A, Gnasso A, Irace C, Romeo P, Claudio Carallo, Cortese C, Colonna A, Pl, Mattioli, Pujia, A, Gnasso, A, Irace, C, Romeo, P, Carallo, C, Cortese, C, Colonna, Alfredo, and Mattioli, Pl

Subjects
Male, Carotid Artery, Common, Cholesterol, HDL, Reproducibility of Results, Blood Pressure, Coronary Disease, Middle Aged, Body Mass Index, Cholesterol, Reference Values, Risk Factors, Surveys and Questionnaires, Hypertension, Humans, Tunica Intima, Tunica Media, Triglycerides, Ultrasonography
Abstract

Intimal plus media thickening has been described to be associated with several cardiovascular risk factors. Aim of the present study was to evaluate the intimal plus media thickness in male subjects with hypertension compared to age matched males normotensive controls. Twenty subjects with hypertension, defined as systolic blood pressure160 mmHg and/or diastolic blood pressure95 mmHg and/or use of antihypertensive drugs, and forty age matched controls have been enrolled. Intimal plus media thickness has been measured from B-mode echography images by a computer. Plasma lipids have been measured by routine methods. A zero random sphygmomanometer has been used to detect blood pressure. Intima plus media thickness resulted enlarged in subjects with hypertension compared to normotensive controls. The thickening of intima-media complex seems related to atherosclerotic lesions, therefore its early detection by noninvasive techniques might improve the identification and the monitoring of high risk hypertensive subjects.

38. Carotid stents reduce longitudinal movements within the vascular wall.

Author

Carallo C, Destito M, Zaffino P, Caglioti C, Silipo V, De Masi PM, Gnasso A, and Spadea MF

Abstract

Background: Longitudinal Displacement (LD) is the relative motion of the intima-media upon adventitia of the arterial wall during the cardiac cycle, probably linked to atherosclerosis. It has a direction, physiologically first backward in its main components with respect to the arterial flow. Here, LD was investigated in various disease and in presence of a unilateral carotid stent., Methods: Carotid acquisitions were performed by ultrasound imaging on both body sides of 75 participants (150 Arteries). LD was measured in its percent quantity and direction., Results: Obesity (p = 0.001) and carotid plaques (p = 0.01) were independently associated to quantity decrease of LD in the whole population. In a subgroup analysis, it was respectively 143% in healthy (n = 48 carotids), 129% (n = 34) in presence of cardiovascular risk factors, 121% (n = 20) in MACE patients, 119% (n = 24) in the carotid contralateral to a stent, 110% (n = 24) in carotids with stents. Regarding the direction of LD, in a subgroup analysis an inverted movement was identified in aged (p = 0.001) and diseased (p = 0.001) participants who also showed less quantity of LD (p = 0.001), but independently with age only (p = 0.002) in the whole population., Conclusions: This observational study suggests that LD within carotid wall layers is lower additively with ageing, cardiovascular risk factors, cardiovascular diseases, and stent. Even if stent is surely beneficial, these data might shed some light on stent restenosis, emphasising the need for interventional studies.

Published
2024
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39. Effects of Vitamin D Supplementation in Patients with Statin-Associated Muscle Symptoms and Low Vitamin D Levels.

Author

Carallo C, Capozza A, and Gnasso A

Subjects
Humans, Cholesterol, LDL, Dietary Supplements, Muscles, Quality of Life, Vitamin D, Vitamins, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Vitamin D Deficiency complications, Vitamin D Deficiency drug therapy
Abstract

Background: Statin therapy is a cornerstone of cardiovascular disease treatment and prevention. Unfortunately, 7%-29% of statin-treated patients complain of muscular fatigue, cramps, and/or pain (statin-associated muscle symptoms [SAMS]). In recent years, the important role of vitamin D in muscle health maintenance has been highlighted. In addition, hypovitaminosis D is very prevalent, and might be a reversible risk factor for SAMS occurrence. Methods: In our controlled intervention study, patients suffering from both SAMS and hypovitaminosis D underwent vitamin D replacement for 6 months. SAMS intensity and its impact on the quality of life were evaluated with a questionnaire during follow-up. A subgroup of patients who were not at the low-density lipoprotein cholesterol (LDL-C) target attempted a statin rechallenge after 3 months. Control subjects, with SAMS only, were not treated. Results: Blood vitamin D levels reached 261% of baseline values. Pain intensity was reduced by 63%, and all life quality indicators improved. At follow-up, percentage variations in SAMS intensity and in vitamin D levels were inversely related ( r  = 0.57, P  = 0.002). In a multiple regression analysis, this association was found to be independent. Among the rechallenge subgroup, 75% successfully tolerated high-intensity statins during the follow-up. The parameters of interest were unchanged in control subjects. Conclusions: In our findings, the amount of increase in vitamin D concentrations is directly related to SAMS improvement. Although randomized studies are needed, 25(OH)D levels can be measured, and eventually supplemented, in all patients suffering from SAMS, and this can be done together with a statin rechallenge after 3 months for patients who are not at the LDL-C target. Register: The study protocol was registered with the EudraCT clinical trial register [ID: 2019-003250-83] in date April 8, 2020.

Published
2022
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40. Autoimmune thyroiditis and celiac disease do not worsen endothelial function in subjects with type 1 diabetes: an observational study.

Author

Parise M, Cutruzzolà A, Scavelli FB, Carallo C, Gnasso A, and Irace C

Abstract

Background: Type 1 diabetes (T1D) is frequently associated with autoimmune thyroiditis (AT) and coeliac disease (CD). Whether the coexistence of multiple autoimmune diseases increases cardiovascular risk is uncertain. We evaluated the effects of AT and CD on arterial wall thickening and endothelial function in patients with T1D., Methods: This observational study analyzed data from T1D patients regularly followed by the Diabetes Care Centre. Clinical and biochemical characteristics and micro and macrovascular complications were collected from the electronic medical records. All subjects performed Echo-Doppler to evaluate Intima-Media Thickness (IMT) of the common carotid artery (CCA) and endothelial function by the flow-mediated dilation (FMD) technique. The statistical analyses were performed by SPSS for Macintosh. Comparison between means was performed using the t-test for unpaired data and the Mann-Whitney U test. The ANalysis Of VAriance and the Tukey posthoc test were applied to compare patients with and without other autoimmune diseases, and control subjects. The p-value for statistical significance was set at p < 0.05., Results: A total of 110 patients were enrolled. Among these, 69 had T1D and 41 T1D and AT and or CD, of whom 33 AT, 7 CD, and 1 both AT and CD. The mean age was 35 years, mean HbA1c was 7.6%, and mean diabetes duration 18 years. The IMT of the CCA was not significantly different between T1D patients with and without concomitant autoimmune diseases (with AT and CD: right CCA 603 ± 186 µ, left 635 ± 175 µ; without AT and CD: right CCA 611 ± 176 µ, left CCA 631 ± 200 µ). FMD was also comparable between T1D groups, with AT and CD 7.9 ± 4.2%; without AT and CD 8.8 ± 4.4%., Conclusion: Patients with T1D and concomitant AT and or CD show no worse morphological or functional vascular damage, evaluated by CCA IMT and brachial artery flow-mediated dilation, than patients with T1D alone., (© 2022. The Author(s).)

Published
2022
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41. Higher heparin dosages reduce thromboembolic complications in patients with COVID-19 pneumonia.

Author

Carallo C, Pugliese F, Vettorato E, Tripolino C, Delle Donne L, Guarrera G, Spagnolli W, and Cozzio S

Abstract

Coronavirus disease 2019 (COVID-19) is a new viral disease complicating with acute thrombophylic conditions, probably also via an inflammatory burden. Anticoagulants are efficacious, but their optimal preventive doses are unknown. The present study was aimed to compare different enoxaparin doses/kg of body weight in the prevention of clot complications in COVID-19 pneumonia. Retrospective data from a cohort of adult patients hospitalized for COVID-19 pneumonia, never underwent to oropharyngeal intubation before admission, were collected in an Internal Medicine environments equipped for non-invasive ventilation. Unfavorable outcomes were considered as: deep venous thrombosis, myocardial infarction, stroke, pulmonary embolism, cardiovascular death. Fourteen clinical thromboembolic events among 42 hospitalized patients were observed. Patients were divided into two group on the basis of median heparin dose (0.5 mg-or 50 IU-for kg). The decision about heparin dosing was patient by patient. Higher enoxaparin therapy (mean 0.62±0.16 mg/kg) showed a better thromboprophylactic action (HR=0.2, p=0.04) with respect to lower doses (mean 0.42±0.06 mg/kg), independently from the clinical presentation of the disease. Therefore, COVID-19 pneumonia might request higher enoxaparin doses to reduce thromboembolic events in hospitalized patients, even if outside intensive care units., Competing Interests: Competing interests: None declared., (© American Federation for Medical Research 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
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42. Early-stage predictors of the acute phase duration in uncomplicated COVID-19 pneumonia.

Author

Carallo C, Pugliese F, Tripolino C, Lenzi L, Oliveri C, Fasani G, Guarrera GM, Spagnolli W, and Cozzio S

Subjects
Blood Platelets pathology, COVID-19 virology, Female, Hospitalization, Humans, Male, Middle Aged, Pneumonia virology, SARS-CoV-2 pathogenicity, COVID-19 pathology, Pneumonia pathology
Abstract

Objective: In this study, we aimed to highlight the common early-stage clinical and laboratory variables independently related to the acute phase duration in patients with uncomplicated coronavirus disease (COVID-19) pneumonia., Methods: In hospitalized patients, the acute phase disease duration was followed using the Brescia-COVID respiratory severity scale. Noninvasive ventilation was administered based on clinical judgment. Patients requiring oropharyngeal intubation were excluded from the study. For parameters to be measured at the hospital entrance, age, clinical history, National Early Warning Score 2 (a multiparametric score system), partial pressure of oxygen in arterial blood/fraction of inspired oxygen (P/F ratio), C-reactive protein, and blood cell count were selected., Results: In 64 patients, age (direct relationship), P/F, and platelet number (inverse relationship) independently accounted for 43% of the acute phase duration of the disease (P < .001)., Conclusions: For the first time, the present results revealed that the acute phase duration of noncomplicated pneumonia, resulting from severe acute respiratory syndrome coronavirus 2, is independently predicted from a patient's age, as well as based on the hospital entrance values of P/F ratio and peripheral blood platelet count., (© 2020 The Authors. Journal of Medical Virology Published by Wiley Periodicals LLC.)

Published
2021
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43. Influence of acute reduction of blood viscosity on endothelial function.

Author

Gnasso A, Cacia M, Cutruzzolà A, Minieri M, Carallo C, Cortese C, and Irace C

Subjects
Adult, Humans, Male, Middle Aged, Blood Viscosity physiology, Endothelium, Vascular physiopathology
Abstract

Background: The relationship between blood viscosity (BV) and endothelial function is rather complex. An increase in BV causes an increase in blood flow resistance, with negative hemodynamic effects; on the other hand, a moderate increase in BV causes an increase in wall stress shear (WSS), and consequent beneficial effects. As a matter of fact, the effect of changes in BV on endothelial function is not yet clear., Objectives: Aim of the present study was to evaluate in-vivo the effects of the acute reduction in BV on endothelial function, in healthy male subjects., Methods: Fourteen healthy male blood donors were studied before and 48 hours after blood donation. Blood and plasma viscosity were measured at 37C° with a cone-plate viscometer. Endothelial function was evaluated through flow mediated vasodilation (FMD)., Results: Blood viscosity was reduced after blood donation (BV225 (cP) 4.53±0.59 vs.4.18±0.31, p < 0.05). FMD 50 s after cuff deflation was unchanged: 6.23±3.84 vs. 6.62±4.81, p = NS. The vasodilation, however, lasted longer and the area under the curve of FMD was significantly increased: 8.74±8.77 vs.16.14±8.65, p < 0.005., Conclusions: The present results demonstrate that the acute reduction of BV prolongs vasodilation, without affecting the amount of vasodilatation, possibly as adaptive reaction allowing more time for oxygen release.

Published
2019
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44. Delayed flow-mediated vasodilation and critical coronary stenosis.

Author

Irace C, De Rosa S, Tripolino C, Ambrosio G, Covello C, Abramo E, Carallo C, Mongiardo A, Spaccarotella C, Torella D, Gnasso A, and Indolfi C

Subjects
Adult, Aged, Aged, 80 and over, Carotid Arteries pathology, Coronary Stenosis epidemiology, Female, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Peripheral Arterial Disease physiopathology, Prevalence, Coronary Stenosis physiopathology, Hemorheology physiology, Vasodilation physiology
Abstract

Endothelial dysfunction, wall thickening and plaque are progressive manifestations of atherosclerosis. Delayed or absent brachial artery dilation after ischemic stimulus has been associated with severity of extracoronary and coronary atherosclerosis. In the current study, we aimed to verify if delayed or absent dilation associates with critical coronary stenosis. We also evaluated the association between coronary stenosis, carotid artery wall thickness and peripheral artery disease. Endothelial function was investigated by flow-mediated dilation of the brachial artery up to 3 min after ischemia, and patients classified as early, late or no dilators. Coronary angiography was performed through transradial or femoral artery approach. Computerized quantitative angiography was used to obtain percent stenosis of all lesions, while the Gensini score was used to evaluate the severity of coronary atherosclerosis. Seventy-four patients were enrolled. Carotid wall thickness and plaque, and peripheral artery disease were detected by ultrasound. Subjects with critical coronary stenosis showed a higher prevalence of delayed or absent dilation (coronary stenosis ≥70 per cent: late dilators 50 per cent, no dilators 35 per cent; coronary stenosis ≤70 per cent : late dilators 27 per cent, no dilators 6 per cent). The Gensini score was progressively higher in late dilators and no dilators compared with early dilators (early: 4.5±13.5; late 17.5±27.1; no 39.7±55.0; P<0.02). Carotid atherosclerosis and peripheral artery disease were more prevalent in subjects with critical coronary stenosis. Delayed or absent dilation associates with coronary stenosis and different degree of coronary atherosclerosis. The kinetic of arterial dilation seems to be relevant as the magnitude of dilation., Competing Interests: Competing interests: None declared., (© American Federation for Medical Research (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2018
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45. No effect on the short-term of a decrease in blood viscosity on insulin resistance.

Author

Gnasso A, Cacia M, Cortese C, Succurro E, Andreozzi F, Carallo C, and Irace C

Subjects
Adult, Healthy Volunteers, Humans, Male, Middle Aged, Blood Viscosity immunology, Insulin Resistance physiology
Abstract

Background: Blood viscosity (BV) might influence glucose delivery to peripheral tissues and play an important role in insulin resistance and diabetes mellitus. However, the exact relationship between BV and insulin resistance is not yet clear., Objectives: Aim of the present study is to evaluate the effects of the acute reduction in BV on insulin resistance, in healthy male subjects., Methods: Fifteen healthy male blood donors have been studied before and 48 hours after blood donation. Blood and plasma viscosity have been measured at 37°C with a cone-plate viscometer. Insulin resistance has been evaluated by euglycemic/hyperinsulinemic clamp in eight subjects, and by iHOMA2 Index in further seven subjects., Results: Blood viscosity was markedly reduced after blood donation (BV225 (cP) 4.53 ± 0.59 vs. 4.18 ± 0.31, p < 0.05). Insulin resistance was unchanged: MFFM clamp: 5.6 ± 4.5vs. 4.4 ± 2.2 and iHOMA2 Index 1.2 ± 0.6 vs. 1.2 ± 0.5, before vs. after respectively, p = NS. Blood pressure and lipids were unchanged after blood donation., Conclusions: The present results demonstrate that acute reduction of BV in healthy male subjects does not change the insulin resistance, measured using both euglycemic/hyperinsulinemic clamp and iHOMA2 Index. Further intervention studies are needed to assess the effect that the reduction in BV can have in subjects with insulin resistance.

Published
2018
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46. Longitudinal Motion Assessment of the Carotid Artery Using Speckle Tracking and Scale-Invariant Feature Transform.

Author

Scaramuzzino S, Carallo C, Pileggi G, Gnasso A, and Spadea MF

Subjects
Adventitia physiopathology, Aged, Algorithms, Carotid Arteries physiopathology, Echocardiography methods, Female, Humans, Male, Observer Variation, Pattern Recognition, Automated methods, Reproducibility of Results, Sensitivity and Specificity, Subtraction Technique, Tunica Intima physiopathology, Tunica Media physiopathology, Adventitia diagnostic imaging, Carotid Arteries diagnostic imaging, Carotid Intima-Media Thickness, Image Interpretation, Computer-Assisted methods, Movement, Tunica Intima diagnostic imaging, Tunica Media diagnostic imaging
Abstract

The purpose of this work is to present and validate a novel approach for ultra-sound-based speckle tracking to measure the carotid artery longitudinal displacement, and to assess the apparent sliding between of Intima-Media Complex (IMC) and Adventitia (Ad) layers. This method utilizes feature detectors and descriptors to localize and track keypoints for local motion quantification. The procedure was tested and validated on an in silico dataset and on 18 heathy volunteers and 16 patients. Accuracy measured on in silico data gave a mean ± standard deviation of 23 ± 15 and 19 ± 18 μm for IMC and Ad respectively, and thus smaller than the pixel size (0.0925 mm). Robustness analysis was performed on in vivo images, obtaining a maximum variation coefficient, over 5 repeated measures, of 9.5 and 13.8% for IMC and Ad, respectively. The novel method capability for detecting the relative motion of IMC vs. Ad was compared with visual assessment performed by 2 physicians, leading to a correlation coefficient R of 0.7 in the worst case. (Healthy group scored by rater #1.) In conclusion, our results provide evidence that the novel method is able to accurately and reliably track carotid artery layer motion and that it overcomes limitations currently present in the literature, therefore providing an automatic tool for clinical evaluation of IMC vs. Ad relative displacement.

Published
2017
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47. Body fat and blood rheology: Evaluation of the association between different adiposity indices and blood viscosity.

Author

Tripolino C, Irace C, Carallo C, Scavelli FB, and Gnasso A

Subjects
Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Rheology, Risk Factors, Adipose Tissue metabolism, Adiposity physiology, Blood Viscosity physiology, Obesity complications
Abstract

Background: In recent years, new measures of body adiposity have been introduced: lipid accumulation product (LAP), body adiposity index (BAI) and body shape index (ABSI). These indices have been demonstrated to better associate with cardiovascular disease than other measures of adiposity., Objectives: The aim of the present study was to evaluate if LAP or BAI better associate with blood viscosity than other measures of adiposity (body mass index, BMI; waist circumference, WC; waist-to-hip ratio, W/HR; waist-to-height ratio, W/HtR)., Methods: 344 subjects were recruited for the present investigation. Exclusion criteria were: diabetes, elevated triglycerides, smoking and drug use. Blood lipids and glucose were measured by routine methods. Blood and plasma viscosity were measured by a cone-plate viscometer. Adiposity measures were computed as previously described., Results: In simple correlation analyses, blood viscosity (BV) correlated with BMI, BAI, and LAP in males and with LAP in females. Correlations between plasma viscosity and adiposity indices were weak and not statistically significant. Other variables significantly related with BV were: gender, HDL- and LDL-Cholesterol, and triglycerides (p < 0.05). In multiple regression analysis only LAP was associated with BV., Conclusions: Our data suggest that LAP index is strongly associated to blood viscosity. This result, along with previous evidence, identifies LAP index as a potential cardiovascular risk marker.

Published
2017
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48. Carotid endothelial shear stress reduction with aging is associated with plaque development in twelve years.

Author

Carallo C, Tripolino C, De Franceschi MS, Irace C, Xu XY, and Gnasso A

Subjects
Aged, Blood Flow Velocity, Cross-Sectional Studies, Disease Progression, Echocardiography, Endothelium, Vascular pathology, Female, Hemodynamics, Humans, Incidence, Longitudinal Studies, Male, Middle Aged, Risk Factors, Stress, Mechanical, Aging, Atherosclerosis epidemiology, Carotid Arteries physiopathology, Shear Strength
Abstract

Background and Aims: Atherosclerosis is associated with clinical, biochemical and haemodynamic risk factors. In a group of subjects studied twelve years apart, we evaluated carotid plaque development in relation to baseline and to changes at follow-up in common carotid haemodynamic profile., Methods: Forty-eight participants were recruited to a cardiovascular disease prevention programme. Atherosclerotic plaques were evaluated and scored by echography. Endothelial shear stress, circumferential wall tension, and Peterson's elastic modulus as an index of arterial stiffness, were computed by echo-Doppler, along with blood viscosity data. Binary logistic regression analyses were used to test the association among the development of atherosclerosis, cardiovascular risk factors and haemodynamic variations. Analyses were also performed on participants who presented at the follow-up with carotid haemodynamic variations in the left or right common carotid only., Results: Participants (69% male) were aged 64.5 ± 9.7 years at follow-up. Peak and mean endothelial shear stress was significantly lower at follow-up as previously reported; circumferential wall tension and arterial stiffness were significantly higher. Carotid plaque scores increased after 12 years (0.39 ± 0.72 vs. 0.67 ± 0.86, p < 0.01). Of the 96 common carotids analysed, shear stress reduction with aging was an independent predictor of carotid atherosclerosis (B = -0.063; odds ratio = 0.94; p = 0.01). Out of 48 participants, 21 (44%) showed shear stress reduction with aging in only one side of the body and, on this side, the plaque score increased (0.52 ± 0.98 vs. 0.90 ± 0.94, p < 0.05), remaining unchanged in the contralateral carotid tree., Conclusions: Aging-related shear stress reduction is an independent predictor of atherosclerosis development., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Published
2016
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49. Hemorheological profiles of subjects with prehypertension.

Author

Tripolino C, Gnasso A, Carallo C, Scavelli FB, and Irace C

Subjects
Blood Glucose, Body Mass Index, Cholesterol, HDL blood, Cholesterol, LDL blood, Disease Susceptibility, Female, Hematocrit, Humans, Male, Middle Aged, Prehypertension diagnosis, Risk Factors, Blood Pressure, Blood Viscosity, Prehypertension blood
Abstract

High blood viscosity is associated with increased peripheral resistance and high blood pressure (BP). Prehypertension refers to a systemic BP of 120-139 mm Hg systolic (SBP) and/or 80-89 mm Hg diastolic (DBP). Subjects with prehypertension have an increased risk of overt hypertension and incident cardiovascular disease compared with subjects who have optimal BP. In the present study, we investigated the hemorheological profiles of subjects with prehypertension. A total of 418 apparently healthy subjects were enrolled. BP, plasma lipids and glucose were measured using routine methods. Blood and plasma viscosity were measured using a cone-plate viscometer. The participants were grouped according to BP into the following categories: 'normotensive' (n=100), 'prehypertensive' (n=172), and 'hypertensive' (n=146). The blood viscosity, plasma viscosity and hematocrit of the prehypertensive subjects were higher than those of the normotensive subjects (P<0.01), but they were comparable to those of the hypertensive subjects. In simple correlation analyses, SBP and DBP were directly and significantly correlated with age, body mass index (BMI), blood glucose, hematocrit, plasma viscosity and blood viscosity. In multiple regression analyses, age, fasting blood glucose and plasma viscosity were independently related with SBP, whereas blood viscosity, fasting blood glucose and BMI significantly predicted DBP. These data demonstrate that BP in the range of so-called prehypertension is accompanied by important hemorheological changes, which are similar to those observed in people with overt hypertension. These results could explain the increased cardiovascular risk observed in these subjects as well as their susceptibility to hypertension.

Published
2016
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50. Red blood cell distribution width predicts two-hours plasma glucose levels during OGTT.

Author

Tripolino C, Irace C, Carallo C, De Franceschi MS, Scavelli FB, and Gnasso A

Subjects
Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Blood Glucose analysis, Diabetes Mellitus, Type 2 diagnosis, Erythrocyte Count methods, Glucose Tolerance Test methods
Abstract

Objective: Red blood cell distribution width (RDW) is a numerical measure, reported as part of a standard complete blood count, usually employed for differential diagnosis of anemic state. Some lines of evidence demonstrate that RDW associates with type 2 diabetes incidence and its complications. To further explore the role of RDW as predictor of abnormal glucose metabolism, we have analyzed the relationship between RDW and 2-hours plasma glucose concentration during an oral glucose tolerance test (OGTT)., Methods: Forty-five outpatients were enrolled for the present study. Participants underwent 75 g OGTT and measurements of hematological parameters. Cardiovascular disease risk factors (blood pressure, blood lipids, cigarette smoking, obesity) were evaluated by routine methods., Results: In simple regression analysis 2-hours post-load glucose was directly associated with age (r = 0.36, p = 0.01), fasting glucose levels (r = 0.40, p = 0.002) and RDW (r = 0.31, p = 0.037). In multiple regression analysis fasting glucose, RDW, triglycerides and age significantly and independently predicted 2-hours plasma glucose (p <  0.01 for all coefficients)., Conclusion: The present findings demonstrate that RDW associates with plasma glucose concentration after a 75-g oral glucose tolerance test. Our results highlight the role of RDW as predictor of glucose metabolism disturbance.

Published
2016
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