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1. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes

Author

Holman, Rr, Bethel, Ma, Mentz, Rj, Thompson, Vp, Lokhnygina, Y, Buse, Jb, Chan, Jc, Choi, J, Gustavson, Sm, Iqbal, N, Maggioni, Ap, Marso, Sp, Öhman, P, Pagidipati, Nj, Poulter, N, Ramachandran, A, Zinman, B, Hernandez, Af, EXSCEL Study Group, : Califf RM, Patel, R, George, J, Sourij, H, Wong, Yw, Hannan, K, Sellers, Ma, Gottlieb, P, Lavender, P, Leloudis, D, Meadows, Y, Larson, D, Anderson, H, Elkins, M, Stone, A, Tisch, A, Perkins, L, Sanders, K, Campbell, C, Kennedy, I, Heal, P, Masterson, M, Darbyshire, J, Mumtaz, L, Athwal, R, Ferch, A, Batra, P, Durborow, L, Vincent, J, Woodall, A, Flanagan, T, Katona, B, Reicher, B, Pozzi, E, Oulhaj, A, Coleman, R, Rouleau, Jl, Pocock, Sj, Gorelick, F, Mcmurray, J, Riddle, M, Gagel, R, Collier, T, Markovic, T, Kong, Aps, Hian, Sk, Scott, R, Panelo, A, Yoon, Kh, Sheu, W, Sritara, P, Linong, J, Pan, C, Yong, H, Schernthaner, G, Mathieu, C, Tankova, T, Widimsky, P, Hanefeld, M, Keltai, M, Wainstein, J, del Prato, S, Pirags, V, Jakuboniene, N, Kooy, A, Dziemidok, P, Veresiu, Ia, Dreval, Av, Murin, J, Torello, Al, Sattar, N, Parkhomenko, O, Omar, M, Diaz, R, Lopes, R, Lanas, F, Urina Triana, M, Leiva-Pons, Jl, Aguliera, D, Bergenstal, R, Goodman, S, Yale, Jf, Caterson, I, Weng, J, Hu, D, Junbo, G, Zannad, F, Anoop, M, Ambrish, M, Gallegos, Ja, Green, Jb, Akerblom, A, Alexander, K, Al-Khatib, S, Armaganijan, L, Barros, P, Batit, M, Bernacki, G, Bernandez, S, Bloomfield, G, Clausen, E, De Souza Brito, F, Devore, A, Dombrowski, K, Eapen, Z, Gellad, Z, George, D, Guimaraes, P, Halim, S, Harrison, R, Hawes, J, Hess, C, Hyland, K, Jackson, L, Jones, S, Jordan, D, Katz, M, Kong, D, Koshizaka, M, Lakey, W, Leblanc, T, Leonardi, S, Luo, N, Mahaffey, K, Mandawat, A, Mehta, R, Melloni, C, Morse, M, Pagidpati, N, Patel, C, Patel, K, Pokorney, S, Posvic, T, Rao, M, Roe, M, Shah, B, Tillmann, H, Truffa, A, Zazula, A, Zeitler, E, Sicer, M, Ulla, Mr, Maffei, L, Klyver, Mi, Calella, P, Alvarisqueta, A, De La Fuente RL, Aizenberg, D, Roque, F, Cruciani, A, Frechtel, G, Gelersztein, E, Villarino, A, Mallagray, M, Nardone, L, Zaidman, C, Novaretto, L, Bartolacci, I, de Salvo, M, Delcourt, C, Crimmins, D, Jackson, R, O’Neal, D, Colman, P, Jeffries, W, Mah, Pm, Wittert, G, Proietto, J, Amerena, J, Marks, S, Tan, R, Colquhoun, D, Pieber, T, Drexel, H, Prager, R, Schnack, C, Hoppichler, F, Fasching, P, Francesconi, C, Luger, A, Schoenherr, Hr, Ebenbichler, C, Paulweber, B, Shernthaner, G, Verhaegen, A, Vanuytsel, J, Thissen, Jp, e Silva P, Barros, Gonzaga, C, Borges, J, Hissa, M, Rea, R, Rossi, P, Chacra, A, Eliaschewitz, F, Garbelini, B, Felicio, J, Rassi, N, Rossi, F, Nunes dos Santos, M, e Farias F, Bandeira, Lisboa, H, e Forti A, Costa, Saraiva, Jk, Kovacheva, S, Levterov, G, Sheinkova, G, Ilieva, E, Lyubenova, L, Damyanova, V, Gushterova, V, Mincheva, L, Illiev, D, Ivanov, V, Bobeva, R, Nikitov, Z, Shumkova, R, Lefterov, In, Zaharieva, S, Videva, V, Yakov, A, Cheung, S, Elliott, T, Mehta, P, Ross, S, Sigal, R, Woo, V, Jaffer, S, Kuritsky, R, Bell, A, Dumas, R, Gosselin, G, Robitaille, Y, Greenspoon, A, Lochnan, H, Tytus, R, Leiter, L, Pandey, A, Punthakee, Z, Dube, F, Sigalas, J, Pearce, M, Woodford, T, Paul, P, Bourgeois, R, Conway, R, Mazza, G, Hatheway, R, Misterski, J, Raffo, C, Olivares, C, Godoy, J, Potthoff, S, Santibañez, C, Larenas Yanez GJ, Gu, W, Shen, F, Ma, J, Guo, X, Li, Q, Du, Y, Hu, J, Ji, L, Li, Y, Deng, H, Feng, Y, Liu, L, Mu, Y, Ma, C, Qu, S, Wang, J, Wang, Y, Yuan, Z, Zhang, L, Zhou, S, Yang, T, Dong, Y, Liu, D, Coronel Arroyo, J, Perez Amador, G, Botero Lopes, R, Jaramilo, C, Orozco Linares, A, Cure Cure CA, Hernandez Triana, E, Molina de Salazar DI, Marin, Cr, Jaramilo Gomez CJ, Kellinerova, I, Adamkova, V, Krami, P, Brychta, T, Havelkova, J, Pantikova, K, Schoper, F, Pohl, W, Schumm-Draeger, Pm, Julius, U, Tschöpe, D, Hamann, A, Seissler, J, Schellong, S, Rose, L, Becker, B, Linn, T, Oerter, Em, Strotmann, Hj, Mölle, A, Pfutzner, A, Forst, T, Schäufele, T, Mugge, A, Lehrke, M, Meyer-Pannwitt, U, Mehling, H, Simon-Wagner, I, Schenkenberger, I, Busch, K, Hermes, S, Milek, K, Landers, B, Grueneberg, M, Braun, M, Nothroff, J, Kamke, W, Hergdt, G, Duengen, Hd, Kleinertz, K, Kuesters, D, Boenninghoff, Ah, Appel, Kf, Schaefer, A, Bieler, T, Ozaki, R, Luk, Aoy, Chu, Dw, Cheung-Wong, Mm, Siu, Dc, Yan, Bpy, Kung, K, Wong, Sys, Tsang, Cc, Yeung, Vt, Cheung, Bm, Tse, Hf, Hodi, G, Nagy, K, Lippai, J, Takacs, J, Fulop, T, Gaal, Z, Pauker, Z, Foldesi, I, Simon, J, Oroszan, T, Futo, L, Bezzegh, K, Nagy, A, Vandorfi, G, Kiss, J, Kesmarki, N, Kis, E, Papp, A, Kovacs, A, Szakal, I, Palinkas, A, Czegany, Z, Voros, P, Reiber, I, Kerenyi, Z, Dezso, E, Wittman, I, Penzes, J, Ples, Z, Taller, A, Farago, K, Kis, Jt, Zilahi, Z, Molnar, M, Barkai, L, Mileder, M, Szentpeteri, I, Peterfai, E, Lovasz, O, Mosenzon, O, Minuchin, O, Jaffe, A, Vishlitsky, V, Shimon, I, Bashkin, A, Stern, N, Elias, N, Bental, T, Butnaru, A, Lewis, B, Adawi, F, Nseir, W, Klainman, E, Herskovits, T, Cignarelli, M, Rotella, Cm, Ambrosio, G, Pozzilli, P, Genovese, S, Cavarape, A, Salvioni, A, Sokolova, J, Strautina, I, Teterovska, D, Stalte, V, Pastare, S, Leitane, I, Lagzdina, L, Andersone, I, Eglite, R, Stelmane, I, Levinger, A, Barsiene, L, Sulskiene, M, Varanauskiene, E, Danyte, E, Urbanaviciene, E, Urbanavicius, V, Zabuliene, L, Juskiene, R, Velaviciene, A, Kakariekiene, V, Augusteniene, A, Velickiene, D, Lasiene, J, Dauksiene, D, Caponis, J, Tan, At, Ramanathan, L, Hassan, Mra, Tan, F, Ong, Tk, Foo, Sh, Ghani, Ra, Cheah, Wk, Sanchez Mijangos JH, Cabrera Jardines, R, Barrientos Perez, M, Sauque Reyna, L, Alcocer Gamba MA, Villeda Espinosa, E, Tamez Perez HE, De La Garza Hernandez NE, Lopes, Sm, Ramirez Diaz SP, Reyes Sanchez, R, Márquez-Rodriguez, E, Köse, V, Voors-Pette, C, Oldenburg-Ligtenberg, Pc, van Kempen WW, Cox, K, Hoogendyk, J, Swinkels-Diepenmaat, L, Rojas-Lingan, G, Kentgens, S, Schipperen, S, de Valk HW, Swart, H, van Bemmel, B, Hoogslag, Pam, Diamant, M, Serné, Eh, Hamer, A, Wilson, S, Fisher, N, Dixon, P, Chaudhri, O, Crawford, V, Quinn, D, Nirmalaraj, K, Dunn, P, Gillies, J, Cutfield, R, Krebs, J, Helm, C, Kerr, J, Pryke, J, Ebo, G, Denopol, M, Ang, E, Uy, N, Jimeno, C, Mirasoi, R, Paz Pacheco, E, Custodio, M, Nicodemus, N Jr, Catindig, Ea, Magno, M, Tirador, L, Cylkowska, B, Stasinksa, T, Silwinska, T, Sroka, M, Piepiorka, M, Korzeniak, R, Mirecka, H, Zaluska, R, Pupek-Musialik, D, Homenda, W, Grabowska, A, Okopien, B, Niegowska, J, Pogorzelska, H, Mikolajczyk-Swatko, A, Sikorski, M, Sowinski, D, Tahk, Sj, Kim, Yn, Nam, Cw, Rim, Sj, Kim, Cj, Choi, Km, Lee, Ik, Kim, Ij, Namgung, J, Moon, Kw, Kim, Ks, Oh, Bh, Lee, Wy, Choi, Sh, Kim, Es, Moon, S, Mindrescu, Nm, Aron, G, Graur, M, Hancu, N, Mlitaru, C, Nafornita, V, Szilagyi, I, Popa, Ar, Angelescu, Lm, Negrisanu, Gd, Zaharie, Dg, Culman, Mi, Vacaru, G, Munteanu, M, Constantinescu, S, Tivadar, S, Dreval, A, Barbarash, O, Strongin, L, Dogadin, S, Suplotova, L, Izmozherova, N, Marasaev, V, Khokhlov, A, Repin, A, Turova, E, Bondar, I, Samoylova, Y, Sherenkov, A, Smolenskaya, O, Zrahevskiy, K, Koshelskaya, O, Obrezan, A, Dzupina, A, Stevlik, J, Buganova, I, Pella, D, Vinanska, D, Jascur, J, Micko, K, Sosovec, D, Philippiova, A, Olexa, P, Fedacko, J, Selecky, J, Nicolau, J, Mediavilla Garcia, J, Botella Serrano, M, Lecube, A, Arguelles, I, Sabán, J, Gómez Cerezo, F, Soto, A, Bellido, D, Sucunza Alfonso, N, Vendrell Ortega, J, Alvarez, L, Garcia Puig, J, Angustias Quesada, M, Contreras Gilbert, J, Almeida, Ca, Tinahones, Fj, Garcia Ortiz, L, Gómez Marcos MA, Aomar, I, Fernández Balsells, M, Distiller, L, Padayachee, T, Badat, A, Ebrahim, I, Naiker, P, Ranjith, N, Kelfkens, Y, Makan, H, Mogashoa, S, Fulat, M, Carim-Ganey, N, Coetzee, K, Govender, T, Nortje, H, Wilhase, A, Seedat, S, Gani, M, Ellis, G, Rheeder, P, Wing, J, Blignaut, S, Kaplan, H, Lottering, H, Pillai, P, Louw, C, Coetzer, T, Sheu, Whh, Chen, Jf, Yang, Cy, Tseng, St, Wang, Cy, Lai, Wt, Hung, Yj, Hsieh, Ic, Su, Sl, Pei, D, Benjasuratwong, Y, Purewal, T, Milward, A, Dimitropoulos, I, Kumar, S, Barber, T, Wiles, P, Dang, C, Adler, A, Philip, S, Bellary, S, Price, D, Oelbaum, R, Heller, S, Sathayapalan, T, Clark, J, Leese, G, Simpson, H, Kilvert, A, Dawson, A, Hall, T, Takhar, A, Bundy, C, Harvey, P, Maxwell, S, Asamoah-Owusu, Nj, Mcknight, J, Chatterjee, S, Calvert, J, Wright, A, Macrury, S, Macfarlane, D, Johnson, A, Litchfield, J, Field, B, Koval, O, Larin, O, Levchenko, O, Martynyuk, L, Maslyanko, V, Rudyk, I, Suprun, Y, Tseluyko, V, Botsyurko, V, Vatutin, M, Fushtey, I, Grishyna, O, Kuskalo, P, Panina, S, Pererva, L, Prysupa, L, Teliatnikova, Z, Sokolova, L, Vlasenko, M, Berenfus, V, Gyrina, O, Kopytsya, M, Vizir, V, Vayda, M, Shanik, M, Headapohl, D, Pahl, J, Aronoff, S, Bartkowiak, A Jr, Chang, A, Gaudiani, L, Kayne, D, Look, M, Patel, N, Moran, J, Stout, E, Tsao, J, Struble, R, Fishman, N, Rodbard, H, Lucas, K, Dugano-Daphnis, P, Merrick, B, Nadar, V, Severa, L, Sorli, C, Chang, M, Reed, J III, Grunberger, G, Bain, C, Bestermann, W Jr, Morawski, E, White, J, Azizad, M, Ukwade, P, Anekwe, A, Jimenez, A, Weiss, D, Green, S, Overcash, J, Eaton, C, Roseman, H, Soler, N, Mikell, F, Manos, P, Levinson, L, Claxton, E Jr, Weiss, R, Argoud, G, Bickel, L, Wilson, J, Short, B, Webster, B, Mcneill, R, Schnall, A, Force, R, Phillips, L, Bybee, K, Forker, A, Denham, D, Vonderhaar, T, Pullman, J, Kruger, D, Whitehouse, F, Wysham, C, Baron, M, Kravitz, A, Dushkin, H, Manning, Mb, Wine, A, Jaffrani, N, Chadha, C, Sperl-Hillen, J, Busch, R, Estevez, R, Robbins, D, Rassouli, N, Garvey, T, Oparil, S, Eckel, R, Mcdermott, M, Rasouli, N, Mcgill, J, Corder, C, Klonoff, D, Mills, R, Earl, J, Kessel, J, Cuddihy, R, Zimmerman, R, Dayamani, P, Oral, E, Zimering, M, Marks, J, Farnsworth, K, Sugimoto, D, Toth, P, Bhargava, A, Mcguire, D, Rohatgi, A, Davies, M, Peden, E, Wyne, K, Alfonso, L, Seyoum, B, Akpunonu, B, Feinglos, M, Reaven, P, Soule, J, Luttrell, L, Schactman, B, Canadas, R, Boggs, B, Abbott, L, Herring, C, Roberts, L, Hage-Korban, E, Schubart, U, Taylon, A, Tannenbaum, A, Kingsley, J, Lenhard, J, Biscoveanu, M, Cohen, J, Donovan, D, Laferrere, B, Thompson, N, Wade, T, Detweiler, R, Henson, B, White, A, Cavale, A, Ravi, C, Thomas, A, Goodman, H, Kalen, V, Fox, D, Dauber, I, Rizvi, S, Marcus, A, Mulford, M, Higgins, A, Chane, M, Bland, V, Osunkoya, A, Suresh, D, Khan, S, Anastasi, L, Bajaj, M, Eisen, H, Mudaliar, Sr, Powell, S, Carr, K, Tripathy, D, Azad, N, Wakefield, P, Acheatel, R, Bressler, P, Dean, J, El Shahawy, M, Gilbert, J, Haque, I, Humiston, D, Ison, R, Karounos, D, Lillestol, M, Ferrier, N, Labroo, A, Vo, A, D’Agostino, R, Dulin, M, Mcwilliams, A, Hargrove, J, Blumberg, E, Jackson, B, Staniloae, C, Salacata, A, Hidalgo, H Jr, Nicol, P, Digiovanna, M, Soufer, J, Mahabadi, V, Akinboboye, O, Arauz-Pacheco, C, Neutel, J, Dungan, K, Benson, M, Powell, T, Gandy, W, Rovner, S, Berk, M, Khan, A, Ledesma, G, Madu, I, Erickson, B, Radbill, M, Graves, M, Kaczmarek, G, Giep, S, Baldauf, C, Golden, G, Lesh, K, Davis, C, Godbole, N, Kirby, W, Razzaque, N, Bhatt, B, Wilson, M., Internal medicine, ACS - Diabetes & metabolism, and ACS - Microcirculation

Subjects
Male, medicine.medical_specialty, EXSCEL Study Group, Injections, Subcutaneous, 030209 endocrinology & metabolism, Type 2 diabetes, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Placebo, Article, Drug Administration Schedule, GLP1-agonists, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Interquartile range, Internal medicine, Diabetes mellitus, General & Internal Medicine, medicine, Humans, Hypoglycemic Agents, Least-Squares Analysis, Aged, Glycated Hemoglobin, business.industry, Venoms, Semaglutide, Incidence, Type 2 diabetes, GLP1-agonists, exenatide, cardiovascular effects, General Medicine, 11 Medical And Health Sciences, Middle Aged, medicine.disease, Surgery, Albiglutide, Editorial, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Exenatide, Dulaglutide, Female, business, Peptides, cardiovascular effects, medicine.drug
Abstract

BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P

Published
2017
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2. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management

Author

Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C. W., le Roux, Carel W., Ortiz, Violante, Jensen, Christine Bjorn, Wilding, John P. H., Hamann, A, Barakat, A, Blüher, M, Linn, T, DALLE MOLLE, Alberto, Segner, A, Stübler, P, Tosch-Sisting, R, Pacini, F, Santini, F, Marchesini, G, Rotella, Cm, Invitti, C, Vettor, R, Buscemi, S, Raya, Pm, Freijoo, Fc, de Barbará RG, Carraro, R, Bobillo, Er, de la Cuesta, C, Farsang, C, Csaszar, A, Zahorska-Markiewicz, B, Pupek-Musialik, D, Franek, E, Ostrowska, L, Olszanecka-Glinianowicz, M, Lalic, N, Micic, D, Ludvik, B, Paulweber, B, Prager, R, Scheen, A, Van Gaal, L, Astrup, Av, Hermansen, K, Madsbad, S, Rissanen, A, Nieminen, S, Savolainen, M, Krempf, M, Romon, M, Laville, M, Marre, M, Mira, R, Finucane, F, Veenendaal, A, van Berkum, F, Johannsson-Vidarsdóttir, S, Van de Walle, V, Meesters, E, Hjelmesæth, J, Klemsdal, To, Kulseng, B, Bach-Kliegel, B, Laederach, K, Villiger, L, Golay, A, Bilz, S, Sathyapalan, T, Bain, S, Kumar, S, Le Roux CW, Lean, Me, Mcgowan, B, Rehman, T, Wilding, J, Wittert, G, Caterson, I, Proietto, J, Prins, J, Geloneze Neto, B, Gross, Jl, Chacra, Ar, Halpern, A, Suplicy Hde, A, Chow, Fc, Thacker, Hp, Chadha, M, Chandalia, H, Unnikrishnan, A, Kalra, S, Deshpande, N, Shunmugavelu, M, Deshmukh, Vc, Maislos, M, Lieberman, Gs, Shimon, I, Stern, N, Nabriski, D, Karnieli, E, Shehadeh, N, Gonzalez-Galvez, G, Arechavaleta-Granell Mdel, R, Violante Ortiz RM, Franco, Gm, Gurieva, I, Suplotova, La, Troshina, E, Ruyatkina, La, Voychik, Ea, Martsevich, S, Startseva, Ma, Seeber, Me, Badat, A, Ellis, G, Altuntas, Y, Guler, S, Ulgen, E, Delibasi, T, Chetty, T, Hart, R, Janzen, J, Labonte, I, Lau, D, Liutkus, J, O'Keefe, D, Padwal, R, Ransom, Tp, Tytus, R, Weisnagel, Sj, Adler, J, Aqua, K, Aronoff, Sl, Bedel, Gw, Blevins, Tc, Blumenau, J, Brockmyre, Ap, Call, Rs, Canadas, R, Chaykin, Lb, Cohen, K, Conrow, Jk, Davis, Mg, Downey, Hj, Drosman, Sr, Duckor, S, Farmer, H, Farrell, J, Fehnel, S, Finneran, Mp, Forbes, R, Forker, A, Fredrick, M, Fujioka, K, Geller, Sa, Gill, S, Glaser, L, Greco, Sn, Greenway, Fl, Harper, W, Herman, L, Hoekstra, J, Ingebretsen, R, Ison, R, Jain, Rk, Kaplan, R, Kaster, Sr, Haase, Ga, Kerzner, B, Kirstein, Jl, Koltun, W, Krieger, Dr, Lewis, Ce, Madder, R, Marple, Rn, Mcdermott, Ej, Mello, Cj, Miller, Ab, Mullen, J, Nardandrea, J, O'Neil, P, Pi-Sunyer, F, Pucillo, Rm, Rhee, C, Redrick, S, Pardini, A, Rothman, J, Rubino, Dm, Sellers, G, Smith, T, Byars, Wd, Soufer, J, Sussman, Am, Patrick, K, Schramm, El, Van Cleeff, M, Berg, Sr, Wyatt, Hr, Simon, Ja., Columbia University [New York], Obesity Research Center, The University of Tennessee [Knoxville], Department of Nutrition, Exercise and Sports [Copenhagen], Faculty of Science [Copenhagen], University of Copenhagen = Københavns Universitet (KU)-University of Copenhagen = Københavns Universitet (KU), Scripps Research Institute, Louisiana State University (LSU), Universidade de São Paulo (USP), Centre hospitalier universitaire de Nantes (CHU Nantes), University of Calgary, University College Dublin (UCD), Instituto Mexicano del Seguro Social [Mexico City, Mexico] (IMSS), Novo Nordisk, Department of Obesity and Endocrinology, University of Liverpool, Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C.W., Le Roux, Carel W., Ortiz, Rafael Violante, Jensen, Christine Bjørn, Wilding, John P.H., the SCALE Obesity and Prediabetes NN8022-1839 Study Group [.., Marchesini, Giulio, ], Pi-Sunyer, X., Astrup, A., Fujioka, K., Greenway, F., Halpern, A., Krempf, M., Lau, D., le Roux, C., Violante Ortiz, R., Jensen, C., Wilding, J. COLLABORATORS: amann A, Barakat A, Blüher M, Linn T, Mölle A, Segner A, Stübler P, Tosch-Sisting R, Pacini F, Santini F, Marchesini G, Rotella CM, Invitti C, Vettor R, Buscemi S, and Raya PM, Freijoo FC, de Barbará RG, Carraro R, Bobillo ER, de la Cuesta C, Farsang C, Csaszar A, Zahorska-Markiewicz B, Pupek-Musialik D, Franek E, Ostrowska L, Olszanecka-Glinianowicz M, Lalic N, Micic D, Ludvik B, Paulweber B, Prager R, Scheen A, Van Gaal L, Astrup AV, Hermansen K, Madsbad S, Rissanen A, Nieminen S, Savolainen M, Krempf M, Romon M, Laville M, Marre M, Mira R, Finucane F, Veenendaal A, van Berkum F, Johannsson-Vidarsdóttir S, Van de Walle V, Meesters E, Hjelmesæth J, Klemsdal TO, Kulseng B, Bach-Kliegel B, Laederach K, Villiger L, Golay A, Bilz S, Sathyapalan T, Bain S, Kumar S, Le Roux CW, Lean ME, McGowan B, Rehman T, Wilding J, Wittert G, Caterson I, Proietto J, Prins J, Geloneze Neto B, Gross JL, Chacra AR, Halpern A, Suplicy Hde A, Chow FC, Thacker HP, Chadha M, Chandalia H, Unnikrishnan A, Kalra S, Deshpande N, Shunmugavelu M, Deshmukh VC, Maislos M, Lieberman GS, Shimon I, Stern N, Nabriski D, Karnieli E, Shehadeh N, Gonzalez-Galvez G, Arechavaleta-Granell Mdel R, Violante Ortiz RM, Franco GM, Gurieva I, Suplotova LA, Troshina E, Ruyatkina LA, Voychik EA, Martsevich S, Startseva MA, Seeber ME, Badat A, Ellis G, Altuntas Y, Guler S, Ulgen E, Delibasi T, Chetty T, Hart R, Janzen J, Labonte I, Lau D, Liutkus J, O'Keefe D, Padwal R, Ransom TP, Tytus R, Weisnagel SJ, Adler J, Aqua K, Aronoff SL, Bedel GW, Blevins TC, Blumenau J, Brockmyre AP, Call RS, Canadas R, Chaykin LB, Cohen K, Conrow JK, Davis MG, Downey HJ, Drosman SR, Duckor S, Farmer H, Farrell J, Fehnel S, Finneran MP, Forbes R, Forker A, Fredrick M, Fujioka K, Geller SA, Gill S, Glaser L, Greco SN, Greenway FL, Harper W, Herman L, Hoekstra J, Ingebretsen R, Ison R, Jain RK, Kaplan R, Kaster SR, Haase GA, Kerzner B, Kirstein JL, Koltun W, Krieger DR, Lewis CE, Madder R, Marple RN, McDermott EJ, Mello CJ, Miller AB, Mullen J, Nardandrea J, O'Neil P, Pi-Sunyer F, Pucillo RM, Rhee C, Redrick S, Pardini A, Rothman J, Rubino DM, Sellers G, Smith T, Byars WD, Soufer J, Sussman AM, Patrick K, Schramm EL, Van Cleeff M, Berg SR, Wyatt HR, Simon JA.

Subjects
Blood Glucose, Counseling, Male, Type 2 diabetes, law.invention, Body Mass Index, Randomized controlled trial, Weight loss, law, Glucagon-Like Peptide 1, Weight management, Subcutaneous, Medicine (all), Reducing, Nausea, General Medicine, Middle Aged, Combined Modality Therapy, 3. Good health, Female, type 2 diabetes, medicine.symptom, Human, medicine.drug, Adult, Diarrhea, medicine.medical_specialty, Diet, Reducing, Injections, Subcutaneous, Injections, Subcutaneou, Placebo, Injections, Double-Blind Method, Internal medicine, Weight Loss, medicine, Humans, Hypoglycemic Agents, Obesity, Exercise, Hypoglycemic Agent, Liraglutide, business.industry, medicine.disease, Weight Lo, Diet, Endocrinology, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Body mass index, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Dyslipidemia
Abstract

BACKGROUND: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS: At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P

Published
2015
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3. Left ventricular dysfunction and outcome at two-year follow-up in patients with type 2 diabetes: The DYDA study

Author

Cioffi G, Faggiano P, Lucci D, Maggioni AP, Manicardi V, Travaglini A, Girfoglio D, Masson S, Giorda CB, Velussi M, Di Lenarda A, Verdecchia P, Comaschi M. DYDA Investigators Collaborators Comaschi M, Giorda C, Tarantini L, de Simone G, Mureddu G, Comaschi M, Latini R, Vago T, Angeli F, Mazzotta G, Repaci S, Botta I, Casalnuovo G, Chinali M, Boemi M, Mocchegiani R, Corsi A, Ponzani P, Camerini A, Pinamonti B, Grosu A, Sforza A, Rambaldi R, Zarra E, Murtas MG, Montaldo C, Motta RM, Leonardi G, Marchese T, Brero ML, Magro G, Tanga M, Rotella CM, Lenuzza M, Baggiore CM, Leopardi A, Minneci C, Sulla A, De Micheli A, Papagna D, Maggi D, Spallarossa P, Aglialoro A, Magaja O, Sabbatini G, Cesareo F, Corda A, Pitzalis L, Masselli L, Midi P, Pontiroli AE, Mauri C, Carletti F, Piatti P, Agricola E, Donà G, Frigato N, Finardi L, Catellani E, Piazza A, Cozzolino D, Madau G, Scanu M, Reboldi G, Biagioli P, Arcangeli A, Marsocci A, Badia T, Dabizzi L, Trojani C, Amati S, Genovese S, Bragato RM, Vespasiani G, Galetta M, Floris F, Mastroianno S, Russo A, De Cosmo S, Sturaro R, Ubaldi S, Miselli V, Gambarati GP, Curci V, Mattioli R, Mezzetti P, Bovelli D, Limone P, Mabritto B, Fonda M, Manca E, Pinamonti B., GENTILE, Sandro, Cioffi, G, Faggiano, P, Lucci, D, Maggioni, Ap, Manicardi, V, Travaglini, A, Girfoglio, D, Masson, S, Giorda, Cb, Velussi, M, Di Lenarda, A, Verdecchia, P, Comaschi M., DYDA Investigators Collaborators Comaschi M, Giorda, C, Tarantini, L, de Simone, G, Mureddu, G, Comaschi, M, Latini, R, Vago, T, Angeli, F, Mazzotta, G, Repaci, S, Botta, I, Casalnuovo, G, Chinali, M, Boemi, M, Mocchegiani, R, Corsi, A, Ponzani, P, Camerini, A, Pinamonti, B, Grosu, A, Sforza, A, Rambaldi, R, Zarra, E, Murtas, Mg, Montaldo, C, Motta, Rm, Leonardi, G, Marchese, T, Brero, Ml, Magro, G, Tanga, M, Rotella, Cm, Lenuzza, M, Baggiore, Cm, Leopardi, A, Minneci, C, Sulla, A, De Micheli, A, Papagna, D, Maggi, D, Spallarossa, P, Aglialoro, A, Magaja, O, Sabbatini, G, Cesareo, F, Corda, A, Pitzalis, L, Masselli, L, Midi, P, Pontiroli, Ae, Mauri, C, Carletti, F, Piatti, P, Agricola, E, Donà, G, Frigato, N, Finardi, L, Catellani, E, Piazza, A, Gentile, Sandro, Cozzolino, D, Madau, G, Scanu, M, Reboldi, G, Biagioli, P, Arcangeli, A, Marsocci, A, Badia, T, Dabizzi, L, Trojani, C, Amati, S, Genovese, S, Bragato, Rm, Vespasiani, G, Galetta, M, Floris, F, Mastroianno, S, Russo, A, De Cosmo, S, Sturaro, R, Ubaldi, S, Miselli, V, Gambarati, Gp, Curci, V, Mattioli, R, Mezzetti, P, Bovelli, D, Limone, P, Mabritto, B, Fonda, M, Manca, E, and Pinamonti, B.

Abstract

Left ventricular dysfunction (LVD) in type 2 diabetes mellitus (DM) (DYDA) study is a prospective investigation enrolling 960 with DM without overt cardiac disease. At baseline, a high prevalence of LVD was detected by analysing midwall shortening. We report here the incidence of clinical events in DYDA patients after 2-year follow-up and the frequency of LVD detected at baseline and 2-year evaluation. METHODS: Systolic LVD was defined as midwall shortening ≤15%, diastolic LVD as any condition different from "normal diastolic function" identified as E/A ratio on Doppler mitral flow between 0.75 and 1.5 and deceleration time of E wave >140 ms. Major outcome was a composite of major events, including all-causes death and hospital admissions. RESULTS: During the study period, any systolic/diastolic LVD was found in 616 of 699 patients (88.1%) in whom LVD function could be measured at baseline or at 2 years. Older age and high HbA1c predicted the occurrence of LVD. During the follow-up 15 patients died (1.6%), 3 for cardiovascular causes, 139 were hospitalized (14.5%, 43 of them for cardiovascular causes, 20 for a new cancer). CONCLUSIONS: During a 2-year follow-up any LVD is detectable in a large majority of patients with DM without overt cardiac disease. Older age and higher HbA1c predict LVD. All-cause death or hospitalization occurred in 15% of patients, cardiovascular cause was uncommon. Independent predictors of events were older age, pathologic lipid profile, high HbA1c, claudicatio and repaglinide therapy. Echo-assessed LVD at baseline was not prognosticator of events. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Published
2013

4. Manifesto delle criticità in nutrizione clinica e preventiva (2015-2018)

Author

Fusco, Ma, Lucchin, L, Dalle Grave, R, Banderali, G, Rovera, Gm, Ballardini, D, Bertoni, G, Gramezi, A, Ronchi, B, Baldi, A, Carruba, M, Lacirignola, M, Agostoni, C, Fargion, S, Donegani, G, Leonardi, F, Mattivi, F, Viola, R, Ferreiro, Ms, Giannini, M, Fatati, G, Grandone, I, Di Lorenzo, N, Carbonelli, Mg, Riccardi, G, Giacco, R, Trimarchi, F, Aroso, M, Corazza, G, Brighenti, F, Casini, A, Giovannini, M, Riva, E, Sirtori, C, Cicero, A, Nisoli, E, Sbraccia, P, Migliaccio, P, Piretta, L, Melchionda, N, Donini, Lorenzo Maria, Guberti, E, Alonzo, E, Giorgino, F, Laviola, L, Agodi, A, Frittitta, L, Rotella, Cm, Dicembrini, I, Morelli, L, Contaldo, F, Gnessi, Lucio, Laviano, Alessandro, Muscaritoli, Maurizio, Pinto, Alessandro, Vania, Andrea, De Lorenzo, A, Di Renzo, L, Vettor, R, D’Andrea, F, Battino, M, and Biolo, G.

Subjects
nutrizione clinica
Published
2015

5. Analysis of midwall shortening reveals high prevalence of left ventricular myocardial dysfunction in patients with diabetes mellitus: the DYDA study

Author

Cioffi G, Giorda CB, Chinali M, Di Lenarda A, Faggiano P, Lucci D, Maggioni AP, Masson S, Mureddu GF, Tarantini L, Velussi M, Comaschi M, DYDA I.n.v.e.s.t.i.g.a.t.o.r.s. Collaborators Comaschi M, Giorda C, de Simone G, Mureddu G, Verdecchia P, Latini R, Vago T, Angeli F, Mazzotta G, Repaci S, Botta I, Casalnuovo G, Girfoglio D, Boemi M, Mocchegiani R, Corsi A, Ponzani P, Camerini A, Pinamonti B, Grosu A, Sforza A, Rambaldi R, Zarra E, Murtas MG, Montaldo C, Motta RM, Leonardi G, Marchese T, Brero ML, Magro G, Tanga M, Rotella CM, Lenuzza M, Baggiore CM, Leopardi A, Minneci C, Sulla A, De Micheli A, Papagna D, Maggi D, Spallarossa P, Aglialoro A, Magaja O, Sabbatini G, Cesareo F, Corda A, Pitzalis L, Masselli L, Midi P, Pontiroli AE, Mauri C, Carletti F, Piatti P, Agricola E, Donà G, Frigato N, Manicardi V, Finardi L, Catellani E, Piazza A, Cozzolino D, Madau G, Scanu M, Reboldi G, Biagioli P, Arcangeli A, Marsocci A, Badia T, Dabizzi L, Trojani C, Amati S, Genovese S, Bragato RM, Vespasiani G, Galetta M, Floris F, Mastroianno S, Russo A, De Cosmo S, Sturaro R, Ubaldi S, Miselli V, Gambarati GP, Curci V, Mattioli R, Travaglini A, Mezzetti P, Bovelli D, Limone P, Mabritto B, Fonda M, Manca E, Pinamonti B., GENTILE, Sandro, Cioffi, G, Giorda, Cb, Chinali, M, Di Lenarda, A, Faggiano, P, Lucci, D, Maggioni, Ap, Masson, S, Mureddu, Gf, Tarantini, L, Velussi, M, Comaschi, M, Collaborators Comaschi M, DYDA I. n. v. e. s. t. i. g. a. t. o. r. s., Giorda, C, de Simone, G, Mureddu, G, Verdecchia, P, Latini, R, Vago, T, Angeli, F, Mazzotta, G, Repaci, S, Botta, I, Casalnuovo, G, Girfoglio, D, Boemi, M, Mocchegiani, R, Corsi, A, Ponzani, P, Camerini, A, Pinamonti, B, Grosu, A, Sforza, A, Rambaldi, R, Zarra, E, Murtas, Mg, Montaldo, C, Motta, Rm, Leonardi, G, Marchese, T, Brero, Ml, Magro, G, Tanga, M, Rotella, Cm, Lenuzza, M, Baggiore, Cm, Leopardi, A, Minneci, C, Sulla, A, De Micheli, A, Papagna, D, Maggi, D, Spallarossa, P, Aglialoro, A, Magaja, O, Sabbatini, G, Cesareo, F, Corda, A, Pitzalis, L, Masselli, L, Midi, P, Pontiroli, Ae, Mauri, C, Carletti, F, Piatti, P, Agricola, E, Donà, G, Frigato, N, Manicardi, V, Finardi, L, Catellani, E, Piazza, A, Gentile, Sandro, Cozzolino, D, Madau, G, Scanu, M, Reboldi, G, Biagioli, P, Arcangeli, A, Marsocci, A, Badia, T, Dabizzi, L, Trojani, C, Amati, S, Genovese, S, Bragato, Rm, Vespasiani, G, Galetta, M, Floris, F, Mastroianno, S, Russo, A, De Cosmo, S, Sturaro, R, Ubaldi, S, Miselli, V, Gambarati, Gp, Curci, V, Mattioli, R, Travaglini, A, Mezzetti, P, Bovelli, D, Limone, P, Mabritto, B, Fonda, M, Manca, E, and Pinamonti, B.

Abstract

Individuals with diabetes mellitus (DM) have a higher risk to develop heart failure. Clinical guidelines emphasize the importance of early diagnosis of left ventricular dysfunction (LVD) and preventive interventions in these patients. In this study we assessed the prevalence of LVD, systolic or diastolic, in DM patients without known cardiac disease recruited in the 'left ventricular DYsfunction in DiAbetes (DYDA)' study. DESIGN AND METHODS: We performed clinical, ECG, laboratory, and echocardiographic exams in 960 patients (61 ± 8 years, 59% hypertensive) recruited in the DYDA study from 37 Italian diabetes referral centres. ECG and echo exams were read in central facilities. Systolic LVD was defined as ejection fraction ≤ 50% or midwall shortening (MFS) ≤ 15%. Diastolic LVD was identified when transmitral E/A was out of the range of 0.75-1.5 or deceleration time of mitral E wave ≤ 140 msec. RESULTS: Echocardiographic data were obtained in 751 patients (78.2%). Isolated systolic LVD was detected in 22.0% of patients, isolated diastolic LVD in 21.5%, and combined systolic and diastolic LVD in 12.7%. All patients with systolic LVD had MFS ≤ 15%, while only 9% had an ejection fraction ≤ 50%. Higher LV mass, relative wall thickness, prevalence of concentric geometry, and LV hypertrophy characterized the patients with LVD. CONCLUSIONS: LVD is present in more than half of DM patients without clinically detectable cardiac disease and is associated with LV hypertrophy and concentric LV geometry. One-third of patients exhibits systolic LVD detectable at the midwall level.

Published
2012

6. Inappropriately high left ventricular mass in patients with type 2 diabetes mellitus and no overt cardiac disease. The DYDA study

Author

Cioffi G, Faggiano P, Lucci D, Di Lenarda A, Mureddu GF, Tarantini L, Verdecchia P, Comaschi M, Giorda CB, Velussi M, Chinali M, Latini R, Masson S, De Simone G, DYDAInvestigators Collaborators Comaschi M, Giorda C, de Simone G, Mureddu G, Maggioni AP, Vago T, Angeli F, Mazzotta G, Repaci S, Botta I, Casalnuovo G, Girfoglio D, Boemi M, Mocchegiani R, Corsi A, Ponzani P, Camerini A, Pinamonti B, Grosu A, Sforza A, Rambaldi R, Zarra E, Murtas MG, Montaldo C, Motta RM, Leonardi G, Marchese T, Brero ML, Magro G, Tanga M, Rotella CM, Lenuzza M, Baggiore CM, Leopardi A, Minneci C, Sulla A, De Micheli A, Papagna D, Maggi D, Spallarossa P, Aglialoro A, Magaja O, Sabbatini G, Cesareo F, Corda A, Pitzalis L, Masselli L, Midi P, PontiroliAE, Mauri C, Carletti F, Piatti P, Agricola E, Donà G, Frigato N, Manicardi V, Finardi L, Catellani E, Piazza A, Cozzolino D, Madau G, Scanu M, Reboldi G, Biagioli P, Arcangeli A, Marsocci A, Badia T, Dabizzi L, Trojani C, Amati S, Genovese S, Bragato RM, Vespasiani G, Galetta M, Floris F, Mastroianno S, Russo A, De Cosmo S, Sturaro R, Ubaldi S, Miselli V, Gambarati GP, Curci V, Mattioli R, Travaglini A, Mezzetti P, Bovelli D, Limone P, Mabritto B, Fonda M, Manca E, Pinamonti B., GENTILE, Sandro, Cioffi, G, Faggiano, P, Lucci, D, Di Lenarda, A, Mureddu, Gf, Tarantini, L, Verdecchia, P, Comaschi, M, Giorda, Cb, Velussi, M, Chinali, M, Latini, R, Masson, S, De Simone, G, DYDAInvestigators Collaborators Comaschi, M, Giorda, C, de Simone, G, Mureddu, G, Maggioni, Ap, Vago, T, Angeli, F, Mazzotta, G, Repaci, S, Botta, I, Casalnuovo, G, Girfoglio, D, Boemi, M, Mocchegiani, R, Corsi, A, Ponzani, P, Camerini, A, Pinamonti, B, Grosu, A, Sforza, A, Rambaldi, R, Zarra, E, Murtas, Mg, Montaldo, C, Motta, Rm, Leonardi, G, Marchese, T, Brero, Ml, Magro, G, Tanga, M, Rotella, Cm, Lenuzza, M, Baggiore, Cm, Leopardi, A, Minneci, C, Sulla, A, De Micheli, A, Papagna, D, Maggi, D, Spallarossa, P, Aglialoro, A, Magaja, O, Sabbatini, G, Cesareo, F, Corda, A, Pitzalis, L, Masselli, L, Midi, P, Pontiroliae, Mauri, C, Carletti, F, Piatti, P, Agricola, E, Donà, G, Frigato, N, Manicardi, V, Finardi, L, Catellani, E, Piazza, A, Gentile, Sandro, Cozzolino, D, Madau, G, Scanu, M, Reboldi, G, Biagioli, P, Arcangeli, A, Marsocci, A, Badia, T, Dabizzi, L, Trojani, C, Amati, S, Genovese, S, Bragato, Rm, Vespasiani, G, Galetta, M, Floris, F, Mastroianno, S, Russo, A, De Cosmo, S, Sturaro, R, Ubaldi, S, Miselli, V, Gambarati, Gp, Curci, V, Mattioli, R, Travaglini, A, Mezzetti, P, Bovelli, D, Limone, P, Mabritto, B, Fonda, M, Manca, E, and Pinamonti, B.

Abstract

An inappropriately high left ventricular mass (iLVM) may be detected in patients with diabetes mellitus. Several hemodynamic and nonhemodynamic factors stimulating LVM growth may actively operate in these patients. In this study, we assessed prevalence and factors associated with iLVM in patients with diabetes mellitus. METHODS: We analyzed baseline data from 708 patients (61 ± 7 years, 57% treated for hypertension) with type 2 diabetes mellitus without evidence of cardiac disease enrolled in the left ventricular dysfunction in diabetes study. iLVM was diagnosed by Doppler echocardiography as LVM more than 28% of the expected LVM predicted from height, sex and stroke work. RESULTS: iLVM was detected in 166 patients (23%), irrespective of concomitant hypertension. Patients with iLVM were more frequently women, had higher BMI and prevalence of metabolic syndrome, higher serum triglyceride levels and were treated more frequently with metformin and diuretics. In a multivariate model, female sex [odds ratio (OR) 1.502 (95% confidence interval (CI) 1.010-2.231), P = 0.04], higher serum triglyceride levels [OR 1.007 (95% CI 1.003-1.012), P

Published
2011

7. Association between plasma triglycerides and HDL-cholesterol and microvascular kidney disease and retinopathy in type 2 diabetes: a global case-control study in 13 countries

Author

Sacks, Fm, Hermans, Mp, Fioretto, P, Valensi, P, Davis, T, Horton, E, Wanner, C, Al Rubeaan, K, Aronson, R, Barzon, I, Bishop, L, Bonora, Enzo, Bunnag, P, Chuang, Lm, Deerochanawong, C, Goldenberg, R, Harshfield, B, Hernández, C, Herzlinger Botein, S, Itoh, H, Jia, W, Jiang, Yd, Kadowaki, T, Laranjo, N, Leiter, L, Miwa, T, Odawara, M, Ohashi, K, Ohno, A, Pan, C, Pan, J, Pedro Botet, J, Reiner, Z, Rotella, Cm, Simo, R, Tanaka, M, Tedeschi Reiner, E, Twum Barima, D, Zoppini, Giacomo, and Carey, Vj

Subjects
diabetes (kidney), epidemiology, lipids, renal function, retinopathy, risk prediction
Published
2014

8. La terapia del diabete mellito tipo 2 basata sulle incretine

Author

DEL PRATO, Stefano, Sesti, G, Bonora, E, Bosi, E, Consoli, A, Cucinotti, D, Ghirlanda, G, Giorgino, F, Lauro, D, Marchetti, Piero, Miccoli, Roberto, Paolisso, G, and Rotella, Cm

Subjects
diabete tipo 2, terapia incretine
Published
2008

27. Zonisamide combined with cognitive behavioral therapy in binge eating disorder: a one-year follow-up study.

Author

Ricca V, Castellini G, Lo Sauro C, Rotella CM, and Faravelli C

Abstract

Objective. Binge eating disorder is a serious, prevalent eating disorder that is associated with overweight. Zonisamide is an antiepileptic drug that can promote weight loss. We evaluated the efficacy and safety of zonisamide as augmentation to individual cognitive behavioral therapy in the treatment of binge eating disorder patients. Design: controlled open study. Participants: Twenty four threshold and subthreshold binge eating disorder patients were enrolled in the cognitive behavioral therapy treatment group, and 28 patients in the cognitive behavioral therapy plus zonisamide group. Measurements: At the beginning (T0), at the end (T1) of treatment, and one year after the end of treatment (T2), body mass index was measured and Eating Disorder Examination- Questionnaire, Binge Eating Scale, Beck Depression Inventory, and State-Trait Anxiety Inventory were administered. Results. At T1 the cognitive behavioral therapy plus zonisamide group showed a higher mean reduction of body mass index, Eating Disorder Examination- Questionnaire, Beck Depression Inventory, and Binge Eating Scale scores. At T2, the cognitive behavior therapy group regained weight, while the cognitive behavioral therapy plus zonisamide group reduced their body mass and showed a higher reduction in binge eating frequency and Binge Eating Scale, Eating Disorder Examination Questionnaire Restraint, and State and Trait Anxiety Inventory scores. Conclusion. The zonisamide augmentation to individual cognitive behavior therapy can improve the treatment of binge eating disorder patients, reducing body weight and the number of binge eating episodes. These results are maintained one year after the end of treatment. [ABSTRACT FROM AUTHOR]

Published
2009

28. Bone fractures and hypoglycemic treatment in type 2 diabetic patients: a case-control study.

Author

Monami M, Cresci B, Colombini A, Pala L, Balzi D, Gori F, Chiasserini V, Marchionni N, Rotella CM, and Mannucci E

Abstract

OBJECTIVE: Hypoglycemic treatments could modulate the risk for fractures in many ways. Most studies have not explored the effect on the incidence of bone fractures of individual oral hypoglycemic agents, rather all oral treatments as a whole. The aim of this case-control study, nested within a retrospective cohort, is the assessment of the risk for bone fractures associated with exposure to insulin or different oral hypoglycemic agents. RESEARCH DESIGN AND METHODS: A case-control study nested within a cohort of 1,945 diabetic outpatients with a follow-up of 4.1 +/- 2.3 years was performed, comparing 83 case subjects of bone fractures and 249 control subjects matched for age, sex, duration of diabetes, BMI, A1C, comorbidity, smoking, and alcohol abuse. Exposure to hypoglycemic drugs during the 10 years preceding the event (or matching index date) was assessed. RESULTS: In a model including treatment with insulin secretagogues metformin and insulin for at least 36 months during the previous 10 years, no significant association was observed between bone fractures and medications. In an alternative model considering treatments at the time of fracture, insulin treatment was significantly associated with bone fractures in men (OR 3.20 [95% CI 1.32-7.74]) but not in women (1.41 [0.73-2.73]). CONCLUSIONS: Insulin-sensitizing treatment with metformin is not associated with a higher incidence of bone fractures, suggesting that the negative effect of thiazolidinediones is due to a specific action on bone metabolism rather a reduction of insulinemia. Conversely, current treatment with insulin increases the risk of fractures; at the same time, exposure to this agent in the longer term does not appear to affect bone frailty. [ABSTRACT FROM AUTHOR]

Published
2008
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29. Feasibility of multiparametric screening for glucose tolerance.

Author

Ognibene A, Mannucci E, Brogi M, Sposato I, Terreni A, Cremasco F, Boddi V, Messeri G, and Rotella CM

Abstract

The sensitivity of fasting plasma glucose (FPG) for the screening of diabetes mellitus could be inadequate in a high-risk population (eg, obesity). Multiparametric analysis could be used for screening in order to identify those patients who should undergo an oral glucose tolerance test (OGTT).In 407 obese patients, a set of 17 demographic, clinical, and laboratory parameters were included in 2 distinct multiparametric analyses using either multivariate logistic regression (MLR) or artificial neural network (aNN). Baseline data were used to predict OGTT-derived diagnosis of diabetes. Sensitivity and specificity of MLR and aNN were compared to those of FPG, with the threshold of 7 mmol/L.A result of FPG>7 mmol/L showed sensitivity of 66%. An analysis of MLR when compared to OGTT-derived diagnosis showed a sensitivity of 89%, and specificity of 97%. Sensitivity and specificity of aNN were 92% and 74%, respectively; among patients who were false positive at aNN, 78% were affected either by impaired glucose tolerance (IGT) and impaired fasting glucose; and 32% of the test patients (versus 1.2% of controls) developed diabetes within 2 years. [ABSTRACT FROM AUTHOR]

Published
2006
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30. Anorexia nervosa and celiac disease: two case reports.

Author

Ricca V, Mannucci E, Calabrò A, Di Bernardo M, Cabras PL, and Rotella CM

Abstract

In its chronic and severe phase, anorexia nervosa (AN) carries a high morbidity and mortality rate. In the severe stage, parenteral alimentation is often required. To date, the optimal regime for parenteral refeeding has not been well documented. Most, if not all, such treatment is performed on an inpatient basis. METHOD: We report here a case of an AN patient treated at home with total parenteral hyperalimentation which is, to the best of our knowledge, the first to be carried out in Israel. RESULTS: The patient has regained 10 kg during treatment, and has maintained her weight a year after treatment. Her gastrointestinal symptoms improved, and she has reduced the amount of laxatives she ingests. DISCUSSION: In this paper we will discuss the various issues and criteria applicable to this treatment, as well as the importance of collaboration between a primary care and specialized clinic. Copyright 2000 by John Wiley & Sons, Inc. [ABSTRACT FROM AUTHOR]

Published
2000
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31. Inflammation markers and metabolic characteristics of subjects with 1-h plasma glucose levels.

Author

Bardini G, Dicembrini I, Cresci B, Rotella CM, Bardini, Gianluca, Dicembrini, Ilaria, Cresci, Barbara, and Rotella, Carlo Maria

Abstract

Objective: To assess the association of 1-h plasma glucose (1hPG) and inflammation with normal glucose tolerance (NGT) and pre-diabetes.Research Design and Methods: A cohort of 1,062 subjects was enrolled. After oral glucose load (oral glucose tolerance test), we compared subjects with NGT and pre-diabetes above and below the 1hPG cut point (155 mg/dl). Fibrinogen and leukocytes count (white blood cells [WBCs]) for subclinical inflammation, lipid ratios, insulin sensitivity (Matsuda index) were determined.Results: Patients with NGT and pre-diabetes (1hPG >155 mg/dl) showed a significant increase of inflammatory markers and lipid ratios (for all, P < 0.05). In age-, sex-, and BMI-adjusted analysis, 1hPG was associated with a significantly higher WBC count and fibrinogen (P < 0.05). Patients with elevated 1hPG showed a highly significant lower insulin sensitivity than subjects <1hPG (P < 0.01).Conclusions: Elevated 1hPG in subjects with NGT and pre-diabetes is associated with subclinical inflammation, high lipid ratios, and insulin resistance. Therefore, 1hPG >155 mg/dl could be considered a new "marker" for cardiovascular risk. [ABSTRACT FROM AUTHOR]

Published
2010
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32. Relationship between leptin and oestrogens in healthy women

Author

Mannucci, E, Ognibene, A, Becorpi, A, Cremasco, F, Pellegrini, S, Ottanelli, S, Rizzello, SM, Massi, G, Messeri, G, and Rotella, CM

Abstract

OBJECTIVE: Leptin. a protein secreted by white adipocytes, plays a relevant role in the regulation of body weight and food intake. A possible role for sex hormones in the regulation of leptin secretion has been suggested; however, the effect of variations in oestrogen concentration on serum leptin levels has not been described so far. METHODS: In study 1, serum leptin concentrations were measured on days 3, 10, 17 and 24 of the menstrual cycle in 18 healthy, lean, regularly menstruating women, aged 18-35 years. Serum oestradiol, progesterone, testosterone. Delta4-androstenedione, dehydroepiandrosterone sulphate (DHEAS). LH and FSH concentrations were also determined. In study 2, serum leptin and oestradiol levels were measured on the 5th and 7th day of ovarian stimulation with human FSH (225 IU daily) during an in vitro fertilisation programme for infertility in 20 women aged 25-45 years. RESULTS: The results from study 1 show a physiological fluctuation of leptin levels during the menstrual cycle, which has not been described previously. Leptin levels are significantly lower in the early follicular phase. The results of study 2 show a parallel increase in serum oestrogen and leptin concentrations during FSH administration. CONCLUSIONS: The fluctuation in leptin levels during the menstrual cycle observed in study 1 is compatible with the hypothesis of a stimulatory effect of oestrogen on leptin secretion. The results of study 2 support the hypothesis of a relevant role for oestrogen in the regulation of leptin secretion. Leptin fluctuations during the menstrual cycle are consistent with reported perimenstrual variations in food craving and consumption.

Published
1998

35. Clinical and psychological correlates of health-related quality of life in obese patients.

Author

Mannucci E, Petroni ML, Villanova N, Rotella CM, Apolone G, Marchesini G, QUOVADIS Study Group, Mannucci, Edoardo, Petroni, Maria L, Villanova, Nicola, Rotella, Carlo M, Apolone, Giovanni, and Marchesini, Giulio

Abstract

Background: Health-related quality of life (HRQL) is poor in obese subjects and is a relevant outcome in intervention studies. We aimed to determine factors associated with poor HRQL in obese patients seeking weight loss in medical units, outside specific research projects.Methods: HRQL, together with a number of demographic and clinical parameters, was studied with generic (SF-36, PGWB) and disease-specific (ORWELL-97) questionnaires in an unselected sample of 1,886 (1,494 women; 392 men) obese (BMI > 30 kg/m2) patients aged 20-65 years attending 25 medical units scattered throughout Italy. The clinics provide weight loss treatment using different programs. General psychopathology (SCL-90 questionnaire), the presence of binge eating (Binge Eating scale), previous weight cycling and somatic comorbidity (Charlson's index) were also determined. Scores on SF-36 and PGWB were compared with Italian population norms, and their association with putative determinants of HRQL after adjustment for confounders was assessed through logistic regression analysis.Results: HRQL scores were significantly lower in women than in men. A greater impairment of quality of life was observed in relation to increasing BMI class, concurrent psychopathology, associated somatic diseases, binge eating, and weight cycling. In multivariate analysis, psychopathology (presence of previously-diagnosed mental disorders and/or elevated scores on SCL-90) was associated with lower HRQL scores on both psychosocial and somatic domains; somatic diseases and higher BMI, after adjustment for confounders, were associated with impairment of physical domains, while binge eating and weight cycling appeared to affect psychosocial domains only.Conclusions: Psychopathological disturbances are the most relevant factors associated with poor HRQL in obese patients, affecting not only psychosocial, but also physical domains, largely independent of the severity of obesity. Psychological/psychiatric interventions are essential for a comprehensive treatment of obesity, and to improve treatment outcome and to reduce the burden of disease. [ABSTRACT FROM AUTHOR]

Published
2010
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37. Cardiovascular Health in Migrants. Current status and issues for prevention. A Collaborative Multidisciplinary Task Force Report

Author

Modesti, Pietro A., Stefano, Bianchi, Claudio, Borghi, Matteo, Cameli, Giovambattista, Capasso, Antonio, Ceriello, Marco Matteo Ciccone, Giuseppe, Germano, Maria, Maiello, Maria Lorenza Muiesan, Salvatore, Novo, Luigi, Padeletti, Pasquale, Palmiero, Sergio, Pillon, Carlo Maria Rotella, Pier Sergio Saba, Pietro, Scicchitano, Bruno, Trimarco, Volpe, Massimo, Roberto, Pedrinelli, Matteo Di Biase, Cardiologia Societa' Italiana, D. I., Societa' Italiana Dell'Ipertensione Arteriosa, Medicina Interna, Societa' Italiana D. I., Nefrologia Societa' Italiana, D. I., Associazione Medici Diabetologi, Cardiostimolazione Associazione Italiana Aritmia, E., Società Italiana Dell'Obesità, Prevenzione Cardiovascolare Societa' Italiana, D. I., Telemedicina Osservatorio Nazionale Della Sanita Elettronica, E., Modesti, Pietro A, Bianchi, Stefano, Borghi, Claudio, Cameli, Matteo, Capasso, Giovambattista, Ceriello, Antonio, Ciccone, Marco Matteo, Germanò, Giuseppe, Maiello, Maria, Muiesan, Maria Lorenza, Novo, Salvatore, Padeletti, Luigi, Palmiero, Pasquale, Pillon, Sergio, Rotella, Carlo Maria, Saba, Pier Sergio, Scicchitano, Pietro, Trimarco, Bruno, Volpe, Massimo, Pedrinelli, Roberto, Di Biase, Matteo, Modesti, PA, Bianchi, S, Borghi, C, Cameli, M, Capasso, G, Ceriello, A, Ciccone, MM, Germanò, G, Maiello, M, Muiesan, ML, Novo, S, Padeletti, L, Palmiero, P, Pillon, S, Rotella, CM, Saba, PS, Scicchitano, P, Trimarco, B, Volpe, M, Pedrinelli, R, Di Biase, M., Modesti, Pa, Ciccone, Mm, Muiesan, Ml, Rotella, Cm, Saba, P, and Di Biase, M

Subjects
cardiovascular risk, Male, medicine.medical_specialty, Economic growth, ethnic, ethnicity, global health, immigration, migrant, minorities, Cardiovascular Diseases, Diabetes Mellitus, Europe, Female, Health Status, Humans, Kidney Diseases, Overweight, Transients and Migrants, Cardiology and Cardiovascular Medicine, Medicine (all), Kidney Disease, media_common.quotation_subject, Immigration, Ethnic group, Health Statu, minoritie, Cardiovascular Disease, Global health, medicine, media_common.cataloged_instance, European union, media_common, cardiovascular risk, ethnic, ethnicity, global health, immigration, migrant, minorities, business.industry, Public health, Diabetes Mellitu, General Medicine, Settore MED/11 - Malattie Dell'Apparato Cardiovascolare, Survey data collection, Social exclusion, business, Diversity (politics), Human
Abstract

OBJECTIVES: To review information on cardiovascular health and migration, to stress the attention of researchers that much needs to be done in the collection of sound data in Italy and to allow policy makers identifying this issue as an important public health concern. BACKGROUND: In Italy, the rate of immigrants in the total number of residents increased from 2.5% in 1990 to 7.4% in 2010, and currently exceeds 10% in regions such as Lombardia, Emilia Romagna and Toscana. METHODS: A consensus statement was developed by approaching relevant Italian national scientific societies involved in cardiovascular prevention. Task force members were identified by the president and/or the boards of each relevant scientific society or working group, as appropriate. To obtain a widespread consensus, drafts were merged and distributed to the scientific societies for local evaluation and revision by as many experts as possible. The ensuing final draft was finally approved by scientific societies. RESULTS: In several western European countries, the prevalence of hypertension, diabetes, chronic kidney disease, obesity and metabolic syndrome was found to be higher among immigrants than in the native population. Although migrants are often initially healthier than non-migrant populations in their host countries, genetic factors, and changing environments with lifestyle changes, social exclusion and insufficient medical control may expose them to health challenges. Cultural reasons may also hamper both the dissemination of prevention strategies and migrant communication with healthcare providers. However, great diversity exists across and within different groups of migrants, making generalizations very difficult and many countries do not collect registry or survey data for migrant's health. CONCLUSIONS: In the present economic context, the European Union is placing great attention to improve data collection for migrant health and to support the implementation of specific prevention policies aimed at limiting the future burden of cardiovascular and renal disease, and the consequent load for health systems. Wider initiatives on the topic are awaited in Italy.

Published
2014

38. The 5-HT2A −1438G/A polymorphism in anorexia nervosa: a combined analysis of 316 trios from six European centres

Author

D. Di Bella, Mònica Gratacòs, Andreas Karwautz, Marie-Christine Mouren-Simeoni, Anke Hinney, Helmut Remschmidt, M. Di Bernardo, Xun Hu, Marta Ribasés, A Kipman, Sandro Sorbi, Carlo Maria Rotella, Johannes Hebebrand, David A. Collier, Benedetta Nacmias, Jean Adès, Valdo Ricca, Laura Bellodi, Elena Cellini, Xavier Estivill, Fernando Fernández-Aranda, Philip Gorwood, Janet Treasure, Gorwood, P, Ades, J, Bellodi, Laura, Cellini, E, Collier, Da, Di Bella, D, Di Bernardo, M, Estivill, X, Fernandez Aranda, F, Gratacos, M, Hebebrand, J, Hinney, A, Hu, X, Karwautz, A, Kipman, A, Mouren Simeoni, Mc, Nacmias, B, Ribases, M, Remschmidt, H, Ricca, V, Rotella, Cm, Sorbi, S, and Treasure, J.

Subjects
Oncology, Risk, medicine.medical_specialty, Linkage disequilibrium, Anorexia Nervosa, Adolescent, Anorexia, Population stratification, Polymorphism, Single Nucleotide, Linkage Disequilibrium, Body Mass Index, Genetic Heterogeneity, Cellular and Molecular Neuroscience, Bias, Internal medicine, medicine, Humans, Point Mutation, Genetic Predisposition to Disease, Receptor, Serotonin, 5-HT2A, Allele, Age of Onset, Promoter Regions, Genetic, Allele frequency, Molecular Biology, Alleles, Genetic association, Genetics, Confounding Factors, Epidemiologic, Europe, Psychiatry and Mental health, Haplotypes, Anorexia nervosa (differential diagnoses), Receptors, Serotonin, medicine.symptom, Psychology, Body mass index
Abstract

Several case-control association studies have raised the possibility that the A allele of a -1438 G/A polymorphism in the type 2A serotonin receptor (HTR2A) gene may be a risk factor for anorexia nervosa. However the absence of linkage and the existence of negative association studies raise the possibility of false positive findings, resulting from population stratification or lack of statistical power. To address this controversy we recruited a sample of 316 patients with anorexia nervosa from six European centres, and utilised a family-based transmission disequilibrium (TDT) approach to analyse the HTR2A-1438 G/A polymorphism. Age at onset and minimal BMI were also taken into consideration in order to detect clinical heterogeneity or a quantitative trait effect. The TDT approach showed that the A allele was transmitted 133 times and not transmitted 148 times (McNemar chi(2) = 0.29, df = 1, P = 0.59). Also, the haplotype-based haplotype relative risk method showed no evidence for association of the A allele, in samples from each centre (chi(2)2.15, df = 1, P0.14) and in the total sample (chi(2) = 0.55, df = 1; P = 0.46). Furthermore, we found no evidence for heterogeneity of the A allele frequency between samples (chi(2) = 2.54, df = 4, P = 0.64), either according to minimal-BMI (F1/242 = 2.14, P = 0.45) or age at onset (F1/224 = 2.39; P = 0.12). QTL-TDT analyses also showed no direct role of the A allele on these traits. We thus found no evidence for a significant role of the 5-HT(2A) gene in anorexia nervosa. Previous results may have been exposed to stratification bias (which we controlled by the TDT method) and/or the risk of type 1 error (from which we were less exposed because of the sample size).

Published
2002
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39. Clinical phenotype and beta-cell autoimmunity in Italian patients with adult-onset diabetes

Author

Paolo Pozzilli, Carlo Maria Rotella, Gabriele Riccardi, G. Bardini, P. Travaglini, A. Ciucci, D. Gonca̧lves, Francesco Purrello, Elena Bazzigaluppi, Maria Gisella Cavallo, O. Vaccaro, Emanuela Morenghi, M. Anello, Emanuele Bosi, Stefano Genovese, Genovese, Salvatore, Bazzigaluppi, E, Goncalves, D, Ciucci, A, Cavallo, Mg, Purrello, F, Anello, M, Rotella, Cm, Bardini, G, Vaccaro, Olga, Riccardi, Gabriele, Travaglini, P, Morenghi, E, Bosi, E, Pozzilli, P., Genovese, S, Vaccaro, O, Riccardi, G, and Bosi, Emanuele

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Glutamate decarboxylase, Disease, Type 2 diabetes, medicine.disease_cause, Autoimmunity, Body Mass Index, Endocrinology, adult-onset diabetes, Internal medicine, Diabetes mellitus, Insulin-Secreting Cells, medicine, Outpatient clinic, Humans, beta-cell autoimmunity, Aged, Autoantibodies, Glycated Hemoglobin, business.industry, Glutamate Decarboxylase, Waist-Hip Ratio, Autoantibody, General Medicine, Middle Aged, medicine.disease, Cross-Sectional Studies, Phenotype, Diabetes Mellitus, Type 2, Italy, Female, Age of onset, Protein Tyrosine Phosphatases, business
Abstract

Objective: To characterize the phenotype of a large population of Italian patients with adult onset (≥40 years) diabetes who were attending outpatient clinics and who were screened for glutamic acid decarboxylase 65 autoantibodies (GADA), protein tyrosine phosphatase IA-2 (IA-2A) and IA-2β/phogrin (IA-2βA).Design and methods: This was a cross-sectional study comprising a total of 881 patients, aged ≤ 70 years, diagnosed with type 2 diabetes after the age of 40 years, and consecutively recruited in five clinics located in different geographic areas of Italy (Milan, Florence, Rome, Naples and Catania). Their mean disease duration was 8.1 (6.9;s.d.) years. GADA, IA-2A and IA-2βA were measured with radiobinding assays within vitrotranslated S-methionine-labelled glutamic acid decarboxylase 65 (GAD65) or IA-2 or IA-2β. Anthropometric and clinical data were collected and compared amongst patients with or without autoantibodies.Results: Sixty-three (7.1%) patients had one or more autoantibodies, 58 (6.6%) had GADA, 22 (2.5%) had IA-2A, six (0.7%) had IA-2βA and 19 (2.15%) had two or more autoantibodies. IA-2A or IA-2βA, in the absence of GADA, were found in only five patients. Autoantibody-positive patients were more often female (63.5 vs 36.5%;P< 0.009), had higher glycated haemoglobin (Hb A1c) (P< 0.001), lower body mass index (BMI;P< 0.0005) and waist/hip ratio (WHR;P< 0.01); female gender being the main contributor to BMI and WHR. We did not observe any differences in age at diagnosis or duration of disease with respect to the presence or absence of islet autoantibodies. The proportion of patients on insulin therapy was higher in patients with two or more antibodies, compared with those with one antibody only, and no antibodies (Pfor trend < 0.001), and among patients with GADA, in those with higher antibody titre (73.9% in those with > 10 units vs 42.0% in those with ≤ 10 units;P< 0.007).Conclusions: Patients with adult onset diabetes characterized by autoimmunity to β-cells showed a clinical phenotype with anthropometric features that differed from those classically observed in patients with type 2 diabetes. The number and titre of autoantibodies, which reflect the severity of autoimmunity and β-cell impairment, amplified this difference. The usefulness of autoantibody screening in adult-onset diabetes is further emphasized by these findings.

Published
2006

40. Characterization of the optimal stimulatory effects of Graves' monoclonal and serum immunoglobulin G on adenosine 3', 5'-monophosphate production in FRTL-5 thyroid cells: a potential clinical assay

Author

Paolo Laccetti, Roberto Toccafondi, Salvatore M. Aloj, William A. Valente, Evelyn F. Grollman, Joshua Cohen, Paolo Vitti, Carlo Maria Rotella, F S Ambesi-Impiombato, Aldo Pinchera, Leonard D. Kohn, Vitti, P, Rotella, Cm, Valente, Wa, Cohen, J, Aloj, Sm, Laccetti, Paolo, Ambesi Impiombato, F, Grollman, Ef, Pinchera, A, Toccafondi, R, and Kohn, Ld

Subjects
endocrine system, medicine.medical_specialty, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Graves' disease, medicine.medical_treatment, Clinical Biochemistry, Cell, Thyroid Gland, Clone (cell biology), Thyrotropin, Stimulation, Biochemistry, Antibodies, Immunoglobulin G, Cell Line, Endocrinology, Internal medicine, Cyclic AMP, medicine, Animals, Humans, Autoantibodies, biology, Chemistry, Antithyroid agent, Biochemistry (medical), Antibodies, Monoclonal, medicine.disease, Thyroid Diseases, Adenosine, Graves Disease, Rats, medicine.anatomical_structure, Monoclonal, biology.protein, Biological Assay, Immunoglobulins, Thyroid-Stimulating, medicine.drug
Abstract

Immunoglobulin G (IgG) preparations derived from the sera of patients with hyperthyroidism due to Graves' disease (TSAb) as well as a monoclonal IgG derived from heterohybridoma fusions of Graves' lymphocytes augmented cAMP levels in a continuous strain of functioning rat thyroid cells (clone FRTL-5) in culture. Optimal stimulation was the same for both types of IgG preparations when measured after 2 h of incubation with 5 X 10(4) cells/well and using cells maintained in a nongrowth, TSH-deficient medium for 7 days. At low IgG concentrations, the stimulatory activities of both preparations exhibited a linear dependence on concentration and similar Ka values (approximately 4 X 10(-8) M) despite the fact that 65% of the Graves' serum IgG preparations had a significantly better ability to inhibit TSH binding to membrane preparations. The Ka value for TSH in the same assay was about 5 X 10(-12) M. Using this cell assay, 90% of a series of hyperthyroid Graves' IgG preparations exhibited stimulating activity, a value comparable to the frequency of positive results found by ourselves and others using human thyroid cell and slice systems. In contrast, only 10% of patients who were euthyroid 1 yr after antithyroid drug withdrawal (n = 21) exhibited stimulating activity, and no stimulating activity was detected in patients with nontoxic nodular goiter (n = 11), toxic adenoma (n = 5), or thyroid carcinoma (n = 6). The studies suggest that an optimized rat FRTL-5 thyroid cell system is a clinically useful and convenient alternative to human thyroid cell and slice systems for detecting TSAbs.

Published
1983

41. Body mass index (BMI), waist circumference (WC), waist-to-height ratio (WHtR) e waist body mass index (wBMI): Which is better?

Author

Moltrer M, Pala L, Cosentino C, Mannucci E, Rotella CM, and Cresci B

Subjects
Area Under Curve, Body Mass Index, Female, Humans, Male, ROC Curve, Risk Factors, Waist Circumference, Obesity diagnosis, Waist-Height Ratio
Abstract

Obesity and overfat are most commonly assessed using the body mass index (BMI), which evaluates "total obesity", without accounting for body fat distribution. Therefore, several indexes of obesity have been proposed, combining BMI with other measures or singular parameters. The aim of the study was to evaluate the accuracy of a new, simple index that takes into account both BMI and Waist Circumference (WC), Waist Body Mass Index (wBMI) in comparison to BMI, WC e Waist-to-Height Ratio (WHtR) for the identification of overfat and obese patients identified by fat mass percentage (FM%). 2400 non diabetic patients were enrolled. From the analysis carried out it emerges that wBMI, BMI, WC and WHtR all have a statistically significant positive correlation (p-Value < 0.001) with FM%. The multivariate analysis showed the positive relationship between these four indexes and the FM. To assess the accuracy of these indices in diagnosing the condition of overfat and obesity we used the statistical analysis Receiver Operating Characteristic (ROC). The Area Under the Curve (AUC) derived from the ROC showed that for the male gender the indicator with the greatest discriminating capacity of the conditions of overfat and obesity was the WHtR and the wBMI for the female gender. The wBMI is therefore configured as an additional tool at the disposal of the healthcare professional aimed at framing the overfat and obese patient and monitoring him during the course of treatment. Moreover wBMI is an indicator able to provide information about the FM% constituting an accurate tool for the evaluation of the overfat and obese patient., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Published
2022
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42. The Florence Emotional Eating Drive (FEED): a validation study of a self-report questionnaire for emotional eating.

Author

Cassioli E, Calderani E, Fioravanti G, Lazzeretti L, Rotella CM, Rossi E, Ricca V, Mannucci E, and Rotella F

Subjects
Cross-Sectional Studies, Emotions, Humans, Psychometrics, Reproducibility of Results, Self Report, Surveys and Questionnaires, Diabetes Mellitus, Type 2
Abstract

Purpose: Emotional eating is a trans-diagnostic dimension in eating disorders and is present in many other conditions that could affect eating attitudes. At present, there is no instrument that measures emotional eating evaluating both the intensity and the frequency of emotion-induced desire to eat. The aim of the study was the validation of the Florence Emotional Eating Drive (FEED)., Methods: A sample of healthy volunteers was initially enrolled to explore internal consistency and test-retest reliability. The Emotional Eating Scale (EES), Eating Disorders Evaluation-Questionnaire (EDE-Q), Binge Eating Scale (BES) and Symptom Checklist-90 (SCL-90-R), together with the final version of FEED, were administered to a clinical sample composed by patients with eating disorders, obesity, and type 2 diabetes, to explore the underlying structure of the questionnaire and verify its validity., Results: FEED showed excellent internal consistency (Cronbach's alpha = 0.96) and test-retest reliability (r = 0.93). FEED scores were higher in patients with BN and BED than in AN patients, negatively correlated with age and positively with BES and EES. Multiple regression analysis showed that FEED, but not EES, was independently associated with SCL-90-R and EDE-Q scores., Conclusion: FEED internal consistency and test-retest reliability were excellent. The addition of specific questions on the frequency of behaviours led to a better component structure and robustness compared to EES. A tool that reliably and specifically assesses eating behaviours driven by emotional states may be extremely useful in clinical settings., Level of Evidence: Level V, cross-sectional study., (© 2021. The Author(s).)

Published
2022
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43. Obesity Therapy: How and Why?

Author

Paccosi S, Cresci B, Pala L, Rotella CM, and Parenti A

Subjects
Adolescent, Anti-Obesity Agents, Diabetes Mellitus, Type 2, Europe, Humans, Phentermine, Obesity therapy
Abstract

Background: Obesity represents the second preventable mortality cause worldwide, and is very often associated with type 2 Diabetes Mellitus (T2DM). The first line treatment is lifestyle modification to weight-loss, but for those who fail to achieve the goal or have difficulty in maintaining achieved results, pharmacological treatment is needed. Few drugs are available today, because of their side effects., Objective: We aim to review actual pharmacological management of obese patients, highlighting differences between Food and Drug Administration - and European Medicine Agency-approved molecules, and pointing out self-medications readily obtainable and widely distributed., Methods: Papers on obesity, weight loss, pharmacotherapy, self- medication and diet-aid products were selected using Medline. Research articles, systematic reviews, clinical trials and meta-analyses were screened., Results: Anti-obesity drugs with central mechanisms, such as phentermine and lorcaserin, are available in USA, but not in Europe. Phentermine/topiramate and naltrexone/bupropion combinations are now available, even though the former is still under investigation from EMA. Orlistat, with peripheral mechanisms, represents the only drug approved for weight reduction in adolescents. Liraglutide has been approved at higher dose for obesity. Anti-obesity drugs, readily obtainable from the internet, include crude-drug products and supplements for which there is often a lack of compliance to national regulatory standards., Conclusions: Mechanisms of weight loss drugs include the reduction of energy intake or the increase in energy expenditure and sense of satiety as well as the decrease of hunger or the reduction in calories absorption. Few drugs are approved, and differences exist between USA and Europe. Moreover, herbal medicines and supplements often sold on the internet and widely used by obese patients, present a risk of adverse effects., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Published
2020
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44. A case of malignant insulinoma responsive to somatostatin analogs treatment.

Author

Caliri M, Verdiani V, Mannucci E, Briganti V, Landoni L, Esposito A, Burato G, Rotella CM, Mannelli M, and Peri A

Subjects
Adipose Tissue pathology, Aged, Duodenum physiology, Duodenum surgery, Humans, Hypoglycemia prevention & control, Insulinoma diagnosis, Insulinoma pathology, Lymphatic Metastasis pathology, Male, Neoplasm Invasiveness pathology, Pancreatectomy, Pancreatic Neoplasms diagnosis, Pancreatic Neoplasms pathology, Preoperative Care, Somatostatin analogs & derivatives, Insulinoma therapy, Octreotide administration & dosage, Pancreatic Neoplasms therapy
Abstract

Background: Insulinoma is a rare tumour representing 1-2% of all pancreatic neoplasms and it is malignant in only 10% of cases. Locoregional invasion or metastases define malignancy, whereas the dimension (> 2 cm), CK19 status, the tumor staging and grading (Ki67 > 2%), and the age of onset (> 50 years) can be considered elements of suspect., Case Presentation: We describe the case of a 68-year-old man presenting symptoms compatible with hypoglycemia. The symptoms regressed with food intake. These episodes initially occurred during physical activity, later also during fasting. The fasting test was performed and the laboratory results showed endogenous hyperinsulinemia compatible with insulinoma. The patient appeared responsive to somatostatin analogs and so he was treated with short acting octreotide, obtaining a good control of glycemia. Imaging investigations showed the presence of a lesion of the uncinate pancreatic process of about 4 cm with a high sst2 receptor density. The patient underwent exploratory laparotomy and duodenocephalopancreasectomy after one month. The definitive histological examination revealed an insulinoma (T3N1MO, AGCC VII G1) with a low replicative index (Ki67: 2%)., Conclusions: This report describes a case of malignant insulinoma responsive to octreotide analogs administered pre-operatively in order to try to prevent hypoglycemia. The response to octreotide analogs is not predictable and should be initially assessed under strict clinical surveillance.

Published
2018
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45. Clinical Approach to Diabetic Cardiomyopathy: A Review of Human Studies.

Author

Tarquini R, Pala L, Brancati S, Vannini G, De Cosmo S, Mazzoccoli G, and Rotella CM

Subjects
Diabetic Cardiomyopathies complications, Diabetic Cardiomyopathies prevention & control, Dyslipidemias drug therapy, Dyslipidemias metabolism, Heart Failure prevention & control, Humans, Hyperglycemia drug therapy, Hyperglycemia metabolism, Magnetic Resonance Imaging methods, Ultrasonography, Doppler methods, Diabetic Cardiomyopathies diagnosis, Diabetic Cardiomyopathies drug therapy, Heart Failure drug therapy
Abstract

Background: Diabetic Cardiomyopathy (DC) has been defined as a distinct entity characterized by the presence of diastolic or systolic cardiac dysfunction in a diabetic patient in the absence of other causes for Cardiomyopathy, such as coronary artery disease (CAD), hypertension (HTN), or valvular heart disease. Diabetes affects every organ in the body and cardiovascular disease accounts for two-thirds of the mortality in the diabetic population. Diabetes-related heart disease occurs in the form of coronary artery disease (CAD), cardiac autonomic neuropathy or DC. The prevalence of cardiac failure is high in the diabetic population and DC is a common, but underestimated cause of heart failure in diabetes. The strong association between diabetes and heart failure has fueled intense human and animal research aimed at identifying the mechanisms underlying diabetic myocardial disease. Despite significant progress made, the precise pathogenesis of diabetic Cardiomyopathy is yet to be clearly defined. Hyperglycemia, dyslipidemia and inflammation are thought to play key roles in the generation of reactive oxygen or nitrogen species which are in turn involved., Methods: We have reviewed the up-to-date scientific literature addressing these issues., Results: The myocardial interstitium undergoes alterations resulting in abnormal contractile function noted in DC. In the early stages of the disease, diastolic dysfunction is the only abnormality, but systolic dysfunction supervenes in the later stages with impaired left ventricular ejection fraction. Transmitral Doppler echocardiography is usually used to assess diastolic dysfunction, but tissue Doppler Imaging and Cardiac Magnetic Resonance Imaging are being increasingly used for early detection of DC. Diabetic patients with microvascular complications show the strongest association between diabetes and Cardiomyopathy, an association that parallels the duration and severity of hyperglycemia., Conclusion: The management of DC involves improvement in lifestyle, control of glucose and lipid abnormalities, together with treatment of hypertension and CAD, if present., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Published
2018
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46. Back to glycemic control: An alternative look at the results of cardiovascular outcome trials in type 2 diabetes.

Author

Mannucci E, Monami M, Ceriello A, and Rotella CM

Subjects
Biomarkers blood, Blood Glucose metabolism, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Clinical Trials as Topic, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 epidemiology, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents adverse effects, Incidence, Protective Factors, Risk Factors, Treatment Outcome, Blood Glucose drug effects, Cardiovascular Diseases prevention & control, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use
Published
2017
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47. Potential Role for Dendritic Cells in Endothelial Dysfunction, Diabetes and Cardiovascular Disease.

Author

Parenti A, Pala L, Paccosi S, and Rotella CM

Subjects
Cardiovascular Diseases pathology, Dendritic Cells pathology, Diabetes Mellitus, Type 2 pathology, Endothelium, Vascular pathology, Humans, Cardiovascular Diseases metabolism, Dendritic Cells metabolism, Diabetes Mellitus, Type 2 metabolism, Endothelium, Vascular metabolism
Abstract

Background: Endothelial dysfunction (ED) is a pathophysiological mechanism present in patients affected by type 2 diabetes (T2DM) supporting the development of cardiovascular disease. Among immune- and inflammatory cells accelerating atherosclerosis, dendritic cells (DC) play a pivotal role, however their pathogenetic mechanism has not been fully clarified, at present. The aim of our review is to explore the relationship between ED, DCs and cardiovascular events., Methods: We analysed the literature in Medline database under ''endothelial function OR dysfunction OR vasodilatation'', AND ''dendritic cells" OR "innate immunity" OR "adaptive immunity" AND "diabetes" AND "cardiovascular disease" OR "atherosclerosis". Research articles, systematic reviews and clinical trials have been screened., Results: Both conventional DCs (cDCs) and plasmacytoid cells (pDCs) have been found in the atherosclerotic lesions, together with other pro-inflammatory cells, leading to increase local inflammation. This inflammatory state drives DC interaction with dysfunctional endothelium activating vascular smooth muscle cells. Clinical studies have reported a dysregulation in circulating DC number and function in T2DM patients, especially in those with macrovascular complications, and a significant correlation between reduction in pDCs, TNF-α production and poor glycemic control has been reported., Conclusion: Several studies have proven the prognostic significance of endothelial function and the accumulation of cDCs and pDCs in the arterial intima, thus suggesting their pathogenetic role in atherogenesis. A lack of clinical results is evident, since most observations on human studies are based on circulating measurements despite the fact that different DCs, residing in different tissues, were not detectable in peripheral blood samples. Further preclinical and clinical studies are needed, which should include the measurement of both circulating and tissueresiding DCs simultaneously., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Published
2017
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48. Lower and higher-potency statins on glycemic control in type 2 diabetes: A retrospective cohort study.

Author

Bardini G, Giannini S, Rotella CM, Pala L, Cresci B, and Mannucci E

Subjects
Aged, Blood Glucose analysis, Female, Humans, Hyperglycemia blood, Hyperglycemia epidemiology, Hypoglycemia blood, Hypoglycemia epidemiology, Italy epidemiology, Male, Middle Aged, Prevalence, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Hyperglycemia diagnosis, Hypoglycemia diagnosis
Abstract

Aims: Evidences showed a link between statins and new-onset diabetes and large clinical trials in type 2 diabetes (T2DM) suggested a mild glycemic progression in statin treated. Since this effect has not yet elucidated in real world, we investigated the effects of different statins on glycemia in T2DM clinic outpatients., Methods: In a retrospective cohort study, we recorded at 6 and 12months modifications of fasting glucose (FPG), HbA1c, diabetes intensification therapy and target rate for HbA1c in 421 T2DM non-users and new statin users. Statins were categorized with low or high potency., Results: Compared to statin users, no statin group showed a significant HbA1c reduction from 52.8±14.0mmol/mol to 48.2±8.5 (p=0.003) at 6months and 48.6±8.8 (p=0.007) at 12months. This trend without statins was also observed in FPG starting from 7.1±2.0mmol/l to 6.7±1.6 (p=0.12) at 6months and 6.6±1.5 (p=0.032) at 12months. Statins determined a significant diabetes treatment intensification: 48.7% vs 27.4% (p=0.002) with hazard ratio 2.4 [95% CI 1.14-5.2], p=0.022. HbA1c target was significantly lower in statin users 62.0% vs 75.4%, p=0.042. Only lower-potency statins showed a significant reduction of HbA1c from 52.0±11.1mmol/mol to 50.7±9.0 (p=0.017) and 50.7±9.5 (p=0.038) at 6 and 12months, respectively. The same effect for these statins was registered in FPG from 7.5±2.2mmol/l to 7.0±1.6 (p=0.021) at 6months and 7.2±1.5 (p=0.026) at 12months., Conclusions: In patients receiving statin therapy a greater intensification diabetes therapy is need. This impact seems to be less pronounced by statins with lower potency., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Published
2016
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49. Variability of triglyceride levels and incidence of microalbuminuria in type 2 diabetes.

Author

Bardini G, Innocenti M, Rotella CM, Giannini S, and Mannucci E

Subjects
Aged, Humans, Incidence, Retrospective Studies, Albuminuria blood, Albuminuria complications, Diabetes Mellitus, Type 2 complications, Triglycerides blood
Abstract

Background: Experimental and clinical studies have shown a strong association between hypertriglyceridemia and diabetic nephropathy. A variability of triglyceride (TG) levels has been reported in diabetes., Objectives: To investigate the relationship of TG variability with the incidence of microalbuminuria (albumin excretion rate > 20 μg/min), in patients with type 2 diabetes., Methods: A longitudinal, retrospective, observational study was performed on a consecutive series of 457 normoalbuminuric outpatients, with measurements of HbA1c, lipids and microalbuminuria thrice per year with 6.8-year follow-up. TG variability, defined as standard deviation of TG (TG-SD) and TG-SD adjusted for the number of visits was calculated. A nested case-control sensitivity analysis was performed to validate the results of the primary cohort study., Results: Incident microalbuminuria (N = 124, 27.1%) was associated with higher median TG-SD (33.6 mg/dL vs 29.0 mg/dL, P < .05) and TG-SD adjusted for the number of visits (31.4 mg/dL vs 26.7 mg/dL, P < .05). At multivariate (Cox) analysis, logTG-SD and adj-logTG-SD were significant predictors of incident microalbuminuria (hazard ratio 2.1 [1.1-4.2], P = .028 and 1.5 [1.1-3.3], P = .042, respectively). In the case-control analysis, time spent with TG > 150 mg/dL during the follow-up was significantly higher in cases vs controls (27.2 ± 19 vs 16.7 ± 12.5 months, P < .05) with hazard ratio 2.0 (1.1-5.1), P < .05, for adj-logTG-SD., Conclusions: A higher intraindividual TG variability is a predictor of incident microalbuminuria in type 2 diabetes. In addition, time of exposure to elevated TG levels (>150 mg/dL) predicts incident microalbuminuria., (Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.)

Published
2016
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50. Gender-related drug effect on several markers of oxidation stress in diabetes patients with and without complications.

Author

Lodovici M, Bigagli E, Luceri C, Mannucci E, Rotella CM, and Raimondi L

Subjects
Aged, Biomarkers blood, C-Reactive Protein analysis, Female, Humans, Male, Malondialdehyde blood, Middle Aged, Sex Factors, Superoxide Dismutase blood, Diabetes Complications blood, Diabetes Mellitus, Type 2 blood, Oxidative Stress
Abstract

We previously reported that circulating lipid (malondialdehyde, MDA) and protein oxidation (carbonyl residues, CO) products can be used as markers of risk for complications in poorly controlled type 2 diabetics. Now, we aimed to evaluate the existence of a gender effect on classical disease markers and oxidative stress parameters and on the effectiveness of metformin and/or statins in reducing CV risk in poorly controlled type 2 diabetics with and without complications. Our results show that diabetics with complications had higher plasma levels of FRAP, SOD and hs-CRP than those without complications, with FRAP and SOD found increased in both genders. Interestingly, male and female patients with complications had higher plasma levels of hs-CRP and MDA respectively, over patients without complications. Multivariate analysis indicated metformin and statin treatments effective in reducing plasma hs-CRP only in female and not in male diabetics with complications. In these latter females, a positive correlation between hs-CRP and triglycerides (TG) levels was found suggesting a causal relationship between them. Statin treatment was effective in reducing MDA in diabetics with complications irrespective of the gender. These data support the addition of statins to diabetic standard therapy to control oxidation injury and inflammation and, for the first time, indicate female patients with complications more responsive than males to the CV protection offered by metformin., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Published
2015
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