6 results on '"Ginestra F."'
Search Results
2. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study
- Author
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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
3. 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
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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. 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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
4. Liraglutide and Renal Outcomes in Type 2 Diabetes
- Author
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Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB, LEADER Steering Committee and Investigators. 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Sachson R, Sack P, Sadler RK, Sahai S, Salazar J, Salgam M, Samal A, Samson A, Sanagorski R, Sanchez A, Sandberg J, Sanderson M, Sandoval J, Santiago E, Sapp T, Saunders J, Schill J, Schott C, Schreiman R, Schu D, Schuh K, Schutta M, Schwartz J, Schweppe L, Scofield H, Scribner A, Seal J, Sealock J, Seaton B, Sedlak-Hanslik T, Seekins K, Segal M, Seggelke S, Semenza S, Sentman P, Serra M, Seshadri P, Sevilla E, Shah S, Shaheen K, Shanik M, Shaw J, Sheets M, Shellabarger C, Sher J, Shippey J, Shivaswamy V, Shomali M, Shore D, Shroff P, Siddiqui T, Siegwald A, Silver R, Simmons D, Simons R, Sinan A, Singh M, Sirinvaravong S, Skero J, Slover-Zipf J, Small S, Smith B, Smith K, Smith M, Sohl J, Solarz SH, Soler D, Sood A, Sora N, Souchet A, Soule J, Sparks J, Spector L, Speicher R, Spillers L, Spivey T, Springer N, Sprouse H, St John J, Stacey A, Stacey H, Stafford M, Stagner E, Staples K, Steadman E, Steed R, Steeves G, Steinberg H, Stell C, Stirman E, Straub K, Strock E, Sue M, Suris O, Sutton T, Tabbah I, Talsania M, Tang R, Tapia J, Taylor K, Taylor-Hancher R, Teator R, Tekateka M, Temple B, Temple K, Teodori M, Tharp P, Thethi T, Theuma P, Thomas S, Thottan A, Thrasher J, Thrasher L, Tiemeyer M, Tinney I, Tobin T, Toma S, Tovar M, Townsend J, Trantow C, Traylor H, Trevino M, Troy M, Trumper D, Tryggestad J, Tucker C, Turner J, Turney R, Tuten C, Tyzack J, Ullo L, Underkofler C, Unger J, Urdanetta R, Valdivia V, Valenti S, Vanderheiden A, Vanderlinde-Wood M, Varma C, Vasquez E, Vazquez M, Vickery D, Villafuerte B, Villegas C, Vivar J, Vivekananthan K, Vo G, Vukojicic K, Wachter A, Wahl D, Waitmann J, Walker D, Walsh J, Walsh K, Walton A, Wang A, Wardell K, Watkins S, Watkinson J, Watts M, Watwe V, Weaver N, Weber R, Wedick C, Weeks D, Weeks L, Weindorff K, Weinstein R, Weiss S, Wenger K, Wentworth M, Werner A, West M, Whelan S, White B, White J, Whitmire M, Whittington R, Wical J, Wigley C, Wilkins F, Will K, Williams A, Wilson LE, Wince M, Wine S, Winkle P, Winner C, Wise J, Witte M, Wittenmyer J, Wood C, Wood R, Woodruff C, Worthington B, Wynn D, Wysham C, Xavier P, Yela S, Yenoby L, Young L, Younus N, Yourell V, Zaid M, Zubair I., Mann, Jfe, Ørsted, Dd, Brown-Frandsen, K, Marso, Sp, Poulter, Nr, Rasmussen, S, Tornøe, K, Zinman, B, Buse, Jb, Bergenstal R, LEADER Steering Committee and Investigators., Daniels, G, Moses, Ac, Nauck, M, Nissen, S, Pocock, S, Steinberg, W, Stockner, M, Kristensen, P, Ravn, L, Zychma, M, Flyvbjerg, A, Ford, I, Kloos, Rt, Schactman, Mj, Sleight, P, Swedberg, K, Tenner, Sm, Akalın, S, Arechavaleta, R, Bain, S, Babkowski, Mc, Benroubi, M, Berard, L, Comlekci, A, Czupryniak, L, Eliasson, B, Eriksson, M, Fonseca, V, Franek, E, Gross, J, Hafidh, K, Haluzik, M, Hayes, F, Huang, Yy, Jacob, S, Kaddaha, G, Khalil, A, Kilhovd, B, Laakso, M, Leiter, L, Lalic, N, Ji, L, Luedemann, J, Mannucci, E, Marre, M, Masmiquel, L, Mota, M, Omar, M, O’Shea, D, Pan, C, Petrie, J, Pieber, T, Pratley, R, Raz, I, Rea, R, Rutten, G, Satman, I, 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S, Pechmann, L, Costa da Penha, P, Perlamagna, L, Perotta, B, Pimentel, L, Pinto, M, Poço, C, Ponte, C, Prazeres, P, Quintao, E, Raduan, R, Rassi, Dt, Rassi, N, Reck, L, Montenegro, R Jr, Ribeiro, R, Rodovalho, S, Silveira Rodrigues, G, Rollin, G, Rossi, S, Sabino, C, Sales, Ap, Salles, J, Sampaio, Cr, Santana, L, Sato, V, da Silva Santos, M, Santos, Nl, Santos, R, Saraiva, J, Sartori, C, Sena, R, Sevilha, M, Sgarbi, J, Silva, D, D'albuquerque Silva, L, Silva, Me, Siqueira, K, Soares, S, Sobreira, W, Sousa, B, Souza, Ac, Souza, B, Tambascia, M, Tarantino, R, Tenor, F, Tomarchio, M, Triches, C, Tristão, Lj, Valenti, A, Vasques, E, Vencio, S, Vianna, A, Munhoz Vidotto, T, Vieira, S, Villar, H, Visconti, G, Volaco, A, Wajchenberg, B, Zanatta, L, Zimmerman, L, Abbott, Ec, Abu-Bakare, A, Advani, A, Allison, R, Bishara, P, Bowering, Ck, Cheng, A, Chouinard, S, Clayton, D, Conway, J, D'Amours, M, de Tugwell, B, Deyoung, P, D'Ignazio, G, Dube, F, Ekoe, Jm, Fagan, S, Garceau, C, Gottesman, I, 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T, Hagan, A, Hager, S, Haggag, A, Haggar, M, Hamilton, M, Hamlet, P, Hammond, J, Hansen, A, Harrell, W, Harris, E, Harris, K, Harris, M, Harrison, L, Hartman, I, Hatch, A, Hayes, D, Hayes, M, Heath, J, Heineman, R, Heinzman, A, Hendrick, M, Herbst, R, Hermayer, K, Hibbard, J, Hill, Wd, Hilliard, B, Hix, M, Hoch, B, Hollander, P, Holmes, Z, Horobetz, C, Horowitz, R, Hsieh, P, Hsieh, S, Htun, W, Huang, J, Huber, C, Hudson, T, Huizar, S, Hull, B, Hull, J, Hummer, K, Hundal, R, Hunt, G, Hunt, V, Hutchinson, P, Hwang, J, Iannamorelli, A, Iannuzzi, L, Ingram, M, Iram, N, Ismail-Beigi, F, Jabbour, S, Jackson, T, Jaen, L, Jain, V, Jannesari, R, Januski, V, Japa, U, Jarvis, K, Jayson, L, Jensen, R, Jester, D, Jocko, C, Johnson, C, Johnson, M, Johnston, K, Jones, D, Jones, J, Jordan, T, Juarez, M, Kaapuraala, A, Kain, A, Kaiser, V, Kamradt, K, Karatoprakli, P, Karegar, M, Karounos, C, Karounos, D, Karunaratne, H, Katalenich, B, Katic, K, Katz, M, Kaur, G, Kawa, A, Keib, C, Keider, G, Kem, D, 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E, Vazquez, M, Vickery, D, Villafuerte, B, Villegas, C, Vivar, J, Vivekananthan, K, Vo, G, Vukojicic, K, Wachter, A, Wahl, D, Waitmann, J, Walker, D, Walsh, J, Walsh, K, Walton, A, Wang, A, Wardell, K, Watkins, S, Watkinson, J, Watts, M, Watwe, V, Weaver, N, Weber, R, Wedick, C, Weeks, D, Weeks, L, Weindorff, K, Weinstein, R, Weiss, S, Wenger, K, Wentworth, M, Werner, A, West, M, Whelan, S, White, B, White, J, Whitmire, M, Whittington, R, Wical, J, Wigley, C, Wilkins, F, Will, K, Williams, A, Wilson, Le, Wince, M, Wine, S, Winkle, P, Winner, C, Wise, J, Witte, M, Wittenmyer, J, Wood, C, Wood, R, Woodruff, C, Worthington, B, Wynn, D, Wysham, C, Xavier, P, Yela, S, Yenoby, L, Young, L, Younus, N, Yourell, V, Zaid, M, Zubair, I., Mann J.F.E., Orsted D.D., Brown-Frandsen K., Marso S.P., Poulter N.R., Rasmussen S., Tornoe K., Zinman B., Buse J.B., and Buscemi S.
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Male ,Settore MED/09 - Medicina Interna ,Acute Kidney Injury ,Aged ,Albuminuria ,Creatinine ,Diabetes Mellitus, Type 2 ,Diabetic Nephropathies ,Double-Blind Method ,Female ,Follow-Up Studies ,Glomerular Filtration Rate ,Glucagon-Like Peptide 1 ,Humans ,Hypoglycemic Agents ,Intention to Treat Analysis ,Kidney Failure, Chronic ,Liraglutide ,Middle Aged ,Type 2 diabetes ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,GLOMERULAR-FILTRATION-RATE ,KIDNEY-FUNCTION ,DISEASE ,law.invention ,Kidney Failure ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Settore MED/49 - Scienze Tecniche Dietetiche Applicate ,Chronic ,RISK ,Kidney ,Acute kidney injury ,11 Medical And Health Sciences ,General Medicine ,medicine.anatomical_structure ,TRIAL ,liraglutide, randomized controlled trial, type 2 diabetes, renal outcomes ,Life Sciences & Biomedicine ,Type 2 ,medicine.drug ,medicine.medical_specialty ,Renal function ,030209 endocrinology & metabolism ,CARDIOVASCULAR OUTCOMES ,Follow-Up Studie ,03 medical and health sciences ,Medicine, General & Internal ,General & Internal Medicine ,Diabetes mellitus ,Internal medicine ,Diabetes Mellitus ,Intensive care medicine ,Science & Technology ,business.industry ,MORTALITY ,medicine.disease ,INTENSIVE GLUCOSE CONTROL ,INDIVIDUALS ,chemistry ,Diabetic Nephropathie ,LEADER Steering Committee and Investigators ,business - Abstract
BACKGROUND: In a randomized, controlled trial that compared liraglutide, a glucagon-like peptide 1 analogue, with placebo in patients with type 2 diabetes and high cardiovascular risk who were receiving usual care, we found that liraglutide resulted in lower risks of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) and death. However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown. METHODS: We report the prespecified secondary renal outcomes of that randomized, controlled trial in which patients were assigned to receive liraglutide or placebo. The secondary renal outcome was a composite of new-onset persistent macroalbuminuria, persistent doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease. The risk of renal outcomes was determined with the use of time-to-event analyses with an intention-to-treat approach. Changes in the estimated glomerular filtration rate and albuminuria were also analyzed. RESULTS: A total of 9340 patients underwent randomization, and the median follow-up of the patients was 3.84 years. The renal outcome occurred in fewer participants in the liraglutide group than in the placebo group (268 of 4668 patients vs. 337 of 4672; hazard ratio, 0.78; 95% confidence interval [CI], 0.67 to 0.92; P=0.003). This result was driven primarily by the new onset of persistent macroalbuminuria, which occurred in fewer participants in the liraglutide group than in the placebo group (161 vs. 215 patients; hazard ratio, 0.74; 95% CI, 0.60 to 0.91; P=0.004). The rates of renal adverse events were similar in the liraglutide group and the placebo group (15.1 events and 16.5 events per 1000 patient-years), including the rate of acute kidney injury (7.1 and 6.2 events per 1000 patient-years, respectively). CONCLUSIONS: This prespecified secondary analysis shows that, when added to usual care, liraglutide resulted in lower rates of the development and progression of diabetic kidney disease than placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048 .).
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- 2017
5. 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
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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
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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.
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- 2012
6. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study
- Author
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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, Galluzzo†, 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
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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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