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15. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

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Wiviott S. D., Raz I., Bonaca M. P., Mosenzon O., Kato E. T., Cahn A., Silverman M. G., Zelniker T. A., Kuder J. F., Murphy S. A., Bhatt D. L., Leiter L. A., McGuire D. K., Wilding J. P. H., Ruff C. T., Nilsson G. I., Fredriksson M., Johansson P. A., Langkilde A. M., Sabatine M. S., Bansilal S., Furtado R., Fish M. P., Gabovitch D., Jevne A., Ahern S., Im K., Goodrich E. L., Lowe C., Fisher N., Gannon J., Trindade S., Towarowski A., Fox Y., Johnsson E., Ranft S., Faber B., Wallander M., Weiss A., Buskila A., Abola M. T. B., Ardissino D., Averkov O., Aylward P., Bode C., Bonnici F., Bonora E., Budaj A. J., Cernea S., Chiang C. E., Cooper M., Dalby A., Deerochanawong C., Dellborg M., Diaz R., Dimulescu D., Eliaschewitz F. G., Goudev A. R., Hadjadj S., Herrera M., Huo Y., Jermendy G., Ji L., Kadowaki T., Kiss R., Kooy A., Kumar K. M. P., Lewis B., Litwak L., Lopez-Sendon J., Ma R., Merlini P. A., Nauck M. A., Nguyen T. K., Nicolau J. C., Ostgren C. J., Ophuis T. O., Padilla F., Pais P., Park K. S., Parkhomenko A., Ray K., Rosenstock J., Ruda M., Satman I., Shestakova M., Smahelova A., Spinar J., Strojek K., Sy R., Tankova T., Theroux P., Tkac I., Van Gaal L., Wainstein J., Harrington R. A., Droller M. J., Lee K. L., Nesto R. W., Tuomilehto J., Hedlin H., Desai M., Sayfer I., Alexanian S., Awtry E., Bentley-Lewis R., Berger C. J., Croce K., Desai A., Garg R. K., Gelfand E., Gignac G., Goessling W., Ho C., Hochberg E., Lane A., Larrey D., Leeman D. E., Lewis J., Link M. S., McDonnell M. E., Norden A. D., Pande A., Rosenberg C., Rost N., Ruberg F., Schiff E., Silverman S., Singhal A., Wagner A., Wolpin B., Aizenberg D., Fernandez M., Sala J., Maffei L., Luquez C., Waitman J., Rista L., Nardone L., Sposetti G., Cantero M., Alvarisqueta A., Montana O., Cuadrado J., Cartasegna L., Baccaro C., Chertkoff A., Sanabria H., Vainstein N., Amerena J., Arya K., d'Emden M., Proietto J., Moses R., Colquhoun D., Stranks S., Lehman R., Hamilton A., Whelan A., Simpson R., Purnell P., Abhayaratna W., Hammett C., McKeirnan M., Sullivan D., Bach L., Hughes K., Mathieu C., Vercammen C., Scheen A., Duyck F., Cools F., De Wolf L., Verhaegen A., Nobels F., Missault L., Crenier L., Thoeng J., Wollaert B., Vandenbroucke M., Eliaschewitz F., Borges J. L. C., Turatti L., Lima F. G., dos Santos F., Kerr Saraiva J., Pereira M., Pereira A., Precoma D. B., Filho G. F. V., Reis G., Maia L. N., Bacheva T., Temelkova-Kurktschiev T., Maneva S., Stoyanovska B., Boshnyashka R., Stoykova Y., Georgiev D., Tagarev Z., Dimitrova E., Vitkina M., Yordanova L., Temelkova M., Vasileva S., Kuneva T., Zyumbyuleva M., Daskalova I., Genadieva V., Boyanov L., Farah G., Lazarova G., Georgieva M., Krasteva S., Slavcheva A., Yabroudi N., Veleva N., Zlateva A., Damyanova V., Elenkova A., Kotselova T., Genov K., Lyubenova L., Temelkova N., Harizanova B., Zaharieva S., Bajaj H., Goldenberg R., Aronson R., Twum-Barima D., Dumas R., Kouz S., Kaiser S. M., Ajala B., Cha J., Teitelbaum I., Chouinard G., Woo V., Dan Dattani I., Mazza G., Gaudet D., Poirier P., Conway J., Dion D., McKeough M., Manyari D., Harris S., St-Pierre B., Yale J. F., Landry D., Gupta M., Hramiak I., Lau D., DeGrace M., Gallo R., Montigny M., Dzongowski P., Liutkus J., Frechette A., Gosselin G., Sabbah E., Langlois M. F., Rabasa-Lhoret R., Bedard J., Hart R., Dowell A., Pandey A., O'Keefe D., Hill L., Weisnagel S. J., Muirhead N., Zimmermann R., Galiwango P., Tobe S., Priestman B., Zinman B., Ma J., Zhao X., Wang C., Zhang A., Dong Y., Dong X., Luo M., Guo J., Zheng Z., Li Y., Liang Y., Peng D., Maderic D., Spinarova L., Raclavska L., Ludka O., Rihacek I., Karasova J., Pelikanova M., Vlasakova H., Urbancova K., Zamrazil V., Hradec J., Vlasicova H., Racicka E., Okenka L., Naplava R., Skopecek J., Palova S., Krystl T., Pistek Z., Oznerova M., Andresova A., Sarbochova R., Taborska P., Petrova I., Stanek L., Reichert P., Lorenc Z., Szabo M., Petit C., Krempf M., Boye A., Dubois S., Clavel S., Gourdy P., Elbaz M., Jazayeri S., Gouet D., Verges B., Couffinhal T., Sendeski M., Klausmann G., Appel K., Pein M., Thieme R., Schumm-Draeger P., Jacob S., Toursarkissian N., Kleinecke-Pohl U., Tschope D., Ott P., Haak T., Nauck M., Derwahl K., Bugger H., Hui G., Tsang C., Zilahi Z., Puski L., Vangel S., Fulop T., Pall K., Hidvegi T., Revesz K., Koranyi L., Kajetan M., Kerenyi Z., Penzes J., Herczeg B., Laszloczky A., Turi T., Rapi J., Pentek Z., Gaal Z., Winkler G., Percs E., Czigany A., Harcsa E., Gurzo M., Tassaly J., Horthy R., Petro G., Farago K., Muller G., Varju I., Kirschner R., Kiss I., Bakai J., Kancz S., Marton Z., Kodur R., Yajnik C., Thomas N., Ayyar V., Iyengar P., Bashkin A., Daoud D., Itzhak B., Katz A., Tsur A., Nikolsky E., Atar S., Grossman A., Klainman E., Tsalihin D., Shotan A., Turgeman Y., Ferrario M., Merlini P., Piatti P., Zenari L., Trevisan R., Bosco B., Di Lorenzo L., Mannucci E., Avogaro A., Reimers B., Trimarco B., Silvestri O., Salvioni A., Nakagawa H., Sueyoshi A., Fukuda K., Yasumoto H., Matsubayashi S., Kawajiri K., Togashi Y., Senokuchi T., Ohta Y., Yamauchi T., Node K., Alcocer Gamba M., Herrera Marmolejo M., De los Rios Ibarra M., Gonzalez Galvez G., Garcia Cantu E., Leguizamo Dimas A., Luna Ceballos R., Medina Pech C., Stobschinski de Alba C., Gonzalez Gonzalez J., Padilla Padilla F., Fanghanel Salmon G., Robles Torres F., Lopez Rosas E., Pelayo Orozco E., Banda Elizondo R., Escalona Caamano A., Frenk Baron P., Aguilar Salinas C., Mustieles Rocha C., Vidrio Velazquez M., Rodriguez Briones I., Saldate Alonso M., Velasco Sanchez R., Groenemeijer B., Ronner E., Kuijper A., Strikwerda S., Van Kempen W., Gijsbers S., Oude Ophuis A., Swart H., Hoogenberg K., Hovens M., van Hessen M., Westerink J., Kragten J., Nierop P., Bax W., Hartong S., Nieuwdorp M., Gonkel F., Al Windy N., Troquay R., Schaafsma H., Lieverse A., Knufman N., Tirador L., Guenon M., Ferrolino A., Atilano A., Aportadera M., Que M., Denopol M., Tolentino M., Jimeno C., Wee J., Mirasol R., Panelo A., Roxas D., Abola M., Palmes P., Silva A., Salvador D., Rosita R., Maravilla L., Rogelio G., Pacheco E., Tin Hay L., Prado J., Krzyzagorska E., Witek R., Miklaszewicz B., Sudnik W., Pomiecko W., Bochenek A., Fares I., Wujkowski M., Korol M., Powierza S., Goch A., Miekus P., Siegel A., Skierkowska J., Romanczuk P., Cygler J., Landa K., Szyprowska E., Stachlewski P., Czerski T., Pawlowicz L., Sowinski D., Romanowski L., Rudzki H., Skorski M., Jasiel-Wojculewicz H., Stasiewski A., Budaj A., Kania G., Mirek-Bryniarska E., Wojnowski L., Korzeniak R., Oh T., Park K., Lee M., Lee K., Jang H., Kim S., Ku B., Cha B., Son H., Lee I., Park J., Yu S., Shon H., Rhee E., Cho J., Park T., Nam J., Pintilei E., Popescu A., Nafornita V., Gutu O., Dumitrescu A., Bala C., Caceaune E., Mindrescu N., Morosanu M., Bradescu O., Munteanu M., Voitec M., Vlaiculescu M., Hancu N., Diaconu Sotropa M., Lupu S., Mateescu A., Carlan L., Marton R., Lupusoru D., Mot A., Coman A., Zaharie D., Rebrov A., Shutemova E., Bolieva L., Khalimov Y., Statsenko M., Galyavich A., Koziolova N., Shapovalova Y., Pavlysh E., Strongin L., Vertkin A., Vishneva E., Pavlova M., Khasanov N., Antsiferov M., Gavrisheva I., Sokolova N., Vorobyev S., Morugova T., Sinitsina I., Ezhov A., Kobalava Z., Belenkiy D., Supryadkina T., Kazakov Y., Oschepkova E., Dreval A., Novikova T., Vishnevsky A., Chizhov D., Akatova E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. B., Tran Q. K., Tran N., Nguyen D., Nguyen V., Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), VA Boston Healthcare System, Turbulence Research Laboratory [Goteborg], Chalmers University of Technology [Göteborg], Wiviott, S, Raz, I, Bonaca, M, Mosenzon, O, Kato, E, Cahn, A, Silverman, M, Zelniker, T, Kuder, J, Murphy, S, Bhatt, D, Leiter, L, Mcguire, D, Wilding, J, Ruff, C, Nilsson, G, Fredriksson, M, Johansson, P, Langkilde, A, Sabatine, M, Bansilal, S, Furtado, R, Fish, M, Gabovitch, D, Jevne, A, Ahern, S, Im, K, Goodrich, E, Lowe, C, Fisher, N, Gannon, J, Trindade, S, Towarowski, A, Fox, Y, Johnsson, E, Ranft, S, Faber, B, Wallander, M, Weiss, A, Buskila, A, Abola, M, Ardissino, D, Averkov, O, Aylward, P, Bode, C, Bonnici, F, Bonora, E, Budaj, A, Cernea, S, Chiang, C, Cooper, M, Dalby, A, Deerochanawong, C, Dellborg, M, Diaz, R, Dimulescu, D, Eliaschewitz, F, Goudev, A, Hadjadj, S, Herrera, M, Huo, Y, Jermendy, G, Ji, L, Kadowaki, T, Kiss, R, Kooy, A, Kumar, K, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Merlini, P, Nauck, M, Nguyen, T, Nicolau, J, Ostgren, C, Ophuis, T, Padilla, F, Pais, P, Park, K, Parkhomenko, A, Ray, K, Rosenstock, J, Ruda, M, Satman, I, Shestakova, M, Smahelova, A, Spinar, J, Strojek, K, Sy, R, Tankova, T, Theroux, P, Tkac, I, Van Gaal, L, Wainstein, J, Harrington, R, Droller, M, Lee, K, Nesto, R, Tuomilehto, J, Hedlin, H, Desai, M, Sayfer, I, Alexanian, S, Awtry, E, Bentley-Lewis, R, Berger, C, Croce, K, Desai, A, Garg, R, Gelfand, E, Gignac, G, Goessling, W, Ho, C, Hochberg, E, Lane, A, Larrey, D, Leeman, D, Lewis, J, Link, M, Mcdonnell, M, Norden, A, Pande, A, Rosenberg, C, Rost, N, Ruberg, F, Schiff, E, Silverman, S, Singhal, A, Wagner, A, Wolpin, B, Aizenberg, D, Fernandez, M, Sala, J, Maffei, L, Luquez, C, Waitman, J, Rista, L, Nardone, L, Sposetti, G, Cantero, M, Alvarisqueta, A, Montana, O, Cuadrado, J, Cartasegna, L, Baccaro, C, Chertkoff, A, Sanabria, H, Vainstein, N, Amerena, J, Arya, K, D'Emden, M, Proietto, J, Moses, R, Colquhoun, D, Stranks, S, Lehman, R, Hamilton, A, Whelan, A, Simpson, R, Purnell, P, Abhayaratna, W, Hammett, C, Mckeirnan, M, Sullivan, D, Bach, L, Hughes, K, Mathieu, C, Vercammen, C, Scheen, A, Duyck, F, Cools, F, De Wolf, L, Verhaegen, A, Nobels, F, Missault, L, Crenier, L, Thoeng, J, Wollaert, B, Vandenbroucke, M, Borges, J, Turatti, L, Lima, F, dos Santos, F, Kerr Saraiva, J, Pereira, M, Pereira, A, Precoma, D, Filho, G, Reis, G, Maia, L, Bacheva, T, Temelkova-Kurktschiev, T, Maneva, S, Stoyanovska, B, Boshnyashka, R, Stoykova, Y, Georgiev, D, Tagarev, Z, Dimitrova, E, Vitkina, M, Yordanova, L, Temelkova, M, Vasileva, S, Kuneva, T, Zyumbyuleva, M, Daskalova, I, Genadieva, V, Boyanov, L, Farah, G, Lazarova, G, Georgieva, M, Krasteva, S, Slavcheva, A, Yabroudi, N, Veleva, N, Zlateva, A, Damyanova, V, Elenkova, A, Kotselova, T, Genov, K, Lyubenova, L, Temelkova, N, Harizanova, B, Zaharieva, S, Bajaj, H, Goldenberg, R, Aronson, R, Twum-Barima, D, Dumas, R, Kouz, S, Kaiser, S, Ajala, B, Cha, J, Teitelbaum, I, Chouinard, G, Woo, V, Dan Dattani, I, Mazza, G, Gaudet, D, Poirier, P, Conway, J, Dion, D, Mckeough, M, Manyari, D, Harris, S, St-Pierre, B, Yale, J, Landry, D, Gupta, M, Hramiak, I, Lau, D, Degrace, M, Gallo, R, Montigny, M, Dzongowski, P, Liutkus, J, Frechette, A, Gosselin, G, Sabbah, E, Langlois, M, Rabasa-Lhoret, R, Bedard, J, Hart, R, Dowell, A, Pandey, A, O'Keefe, D, Hill, L, Weisnagel, S, Muirhead, N, Zimmermann, R, Galiwango, P, Tobe, S, Priestman, B, Zinman, B, Ma, J, Zhao, X, Wang, C, Zhang, A, Dong, Y, Dong, X, Luo, M, Guo, J, Zheng, Z, Li, Y, Liang, Y, Peng, D, Maderic, D, Spinarova, L, Raclavska, L, Ludka, O, Rihacek, I, Karasova, J, Pelikanova, M, Vlasakova, H, Urbancova, K, Zamrazil, V, Hradec, J, Vlasicova, H, Racicka, E, Okenka, L, Naplava, R, Skopecek, J, Palova, S, Krystl, T, Pistek, Z, Oznerova, M, Andresova, A, Sarbochova, R, Taborska, P, Petrova, I, Stanek, L, Reichert, P, Lorenc, Z, Szabo, M, Petit, C, Krempf, M, Boye, A, Dubois, S, Clavel, S, Gourdy, P, Elbaz, M, Jazayeri, S, Gouet, D, Verges, B, Couffinhal, T, Sendeski, M, Klausmann, G, Appel, K, Pein, M, Thieme, R, Schumm-Draeger, P, Jacob, S, Toursarkissian, N, Kleinecke-Pohl, U, Tschope, D, Ott, P, Haak, T, Derwahl, K, Bugger, H, Hui, G, Tsang, C, Zilahi, Z, Puski, L, Vangel, S, Fulop, T, Pall, K, Hidvegi, T, Revesz, K, Koranyi, L, Kajetan, M, Kerenyi, Z, Penzes, J, Herczeg, B, Laszloczky, A, Turi, T, Rapi, J, Pentek, Z, Gaal, Z, Winkler, G, Percs, E, Czigany, A, Harcsa, E, Gurzo, M, Tassaly, J, Horthy, R, Petro, G, Farago, K, Muller, G, Varju, I, Kirschner, R, Kiss, I, Bakai, J, Kancz, S, Marton, Z, Kodur, R, Yajnik, C, Thomas, N, Ayyar, V, Iyengar, P, Bashkin, A, Daoud, D, Itzhak, B, Katz, A, Tsur, A, Nikolsky, E, Atar, S, Grossman, A, Klainman, E, Tsalihin, D, Shotan, A, Turgeman, Y, Ferrario, M, Piatti, P, Zenari, L, Trevisan, R, Bosco, B, Di Lorenzo, L, Mannucci, E, Avogaro, A, Reimers, B, Trimarco, B, Silvestri, O, Salvioni, A, Nakagawa, H, Sueyoshi, A, Fukuda, K, Yasumoto, H, Matsubayashi, S, Kawajiri, K, Togashi, Y, Senokuchi, T, Ohta, Y, Yamauchi, T, Node, K, Alcocer Gamba, M, Herrera Marmolejo, M, De los Rios Ibarra, M, Gonzalez Galvez, G, Garcia Cantu, E, Leguizamo Dimas, A, Luna Ceballos, R, Medina Pech, C, Stobschinski de Alba, C, Gonzalez Gonzalez, J, Padilla Padilla, F, Fanghanel Salmon, G, Robles Torres, F, Lopez Rosas, E, Pelayo Orozco, E, Banda Elizondo, R, Escalona Caamano, A, Frenk Baron, P, Aguilar Salinas, C, Mustieles Rocha, C, Vidrio Velazquez, M, Rodriguez Briones, I, Saldate Alonso, M, Velasco Sanchez, R, Groenemeijer, B, Ronner, E, Kuijper, A, Strikwerda, S, Van Kempen, W, Gijsbers, S, Oude Ophuis, A, Swart, H, Hoogenberg, K, Hovens, M, van Hessen, M, Westerink, J, Kragten, J, Nierop, P, Bax, W, Hartong, S, Nieuwdorp, M, Gonkel, F, Al Windy, N, Troquay, R, Schaafsma, H, Lieverse, A, Knufman, N, Tirador, L, Guenon, M, Ferrolino, A, Atilano, A, Aportadera, M, Que, M, Denopol, M, Tolentino, M, Jimeno, C, Wee, J, Mirasol, R, Panelo, A, Roxas, D, Palmes, P, Silva, A, Salvador, D, Rosita, R, Maravilla, L, Rogelio, G, Pacheco, E, Tin Hay, L, Prado, J, Krzyzagorska, E, Witek, R, Miklaszewicz, B, Sudnik, W, Pomiecko, W, Bochenek, A, Fares, I, Wujkowski, M, Korol, M, Powierza, S, Goch, A, Miekus, P, Siegel, A, Skierkowska, J, Romanczuk, P, Cygler, J, Landa, K, Szyprowska, E, Stachlewski, P, Czerski, T, Pawlowicz, L, Sowinski, D, Romanowski, L, Rudzki, H, Skorski, M, Jasiel-Wojculewicz, H, Stasiewski, A, Kania, G, Mirek-Bryniarska, E, Wojnowski, L, Korzeniak, R, Oh, T, Lee, M, Jang, H, Kim, S, Ku, B, Cha, B, Son, H, Lee, I, Park, J, Yu, S, Shon, H, Rhee, E, Cho, J, Park, T, Nam, J, Pintilei, E, Popescu, A, Nafornita, V, Gutu, O, Dumitrescu, A, Bala, C, Caceaune, E, Mindrescu, N, Morosanu, M, Bradescu, O, Munteanu, M, Voitec, M, Vlaiculescu, M, Hancu, N, Diaconu Sotropa, M, Lupu, S, Mateescu, A, Carlan, L, Marton, R, Lupusoru, D, Mot, A, Coman, A, Zaharie, D, Rebrov, A, Shutemova, E, 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Kamlet, J, Wheeler, K, Hurley, S, Sharma, S, Wefald, F, Hershon, K, O'Connor, T, Pueblitz, G, Laguerre, J, Amin, M, Alfonso, T, Jaffrani, N, Isserman, S, Portnay, E, Vlastaris, A, Dy, J, Hagan, M, Noveck, H, Kraft, P, Andersen, J, Foley, B, Carr, K, Gelormini, J, Williams, T, Landau, C, Richwine, R, Thakkar, M, Karim, A, Madhun, Z, Francyk, D, Lamantia, J, Baker, B, Zhang, W, Lev, V, Hasan, M, Captain, A, Herzog, W, Friedman, K, Lawson, W, Desai, V, Ow, C, Simons, R, Mandviwala, M, Le, T, Hack, T, Zebrack, J, Henderson, D, Dejulia, J, Mehta, R, Reza, S, Poonawala, R, Awad, A, Velasquez, M, Mohiuddin, S, Salazar Sharma, M, Myrick, G, Gottlieb, D, Ovalle, F, Alfieri, A, Ahmed, S, Bohula, E, Donahoe, S, Longshaw, K, Eshaghian, S, Lash, J, Goldberg, R, Fox, B, Mostel, E, Dobies, D, Ward, H, Burbano, J, Puleo, P, Lenhard, M, Korn, D, Thadani, U, Bradley, A, Kmetzo, J, Heasley, E, Raikhel, M, Mahr, N, Bittar, G, Fuentes, F, Raghu, P, Diep, T, Tran, Q, Tran, N, Nguyen, D, and Nguyen, V

Subjects
Male, medicine.medical_specialty, dapagliflozin, placebo, [SDV]Life Sciences [q-bio], Renal function, Type 2 diabetes, [SDV.BC]Life Sciences [q-bio]/Cellular Biology, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Glucosides, Diabetes mellitus, Internal medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Benzhydryl Compounds, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, ComputingMilieux_MISCELLANEOUS, Aged, Heart Failure, Canagliflozin, business.industry, [SDV.BA]Life Sciences [q-bio]/Animal biology, General Medicine, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, Hospitalization, Diabetes Mellitus, Type 2, chemistry, Cardiovascular Diseases, Heart failure, Cardiology, Female, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Mace, medicine.drug
Abstract

BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3%vs. 0.1%, P = 0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P≥0.001). CONCLUSIONS In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARETIMI 58 ClinicalTrials.gov number, NCT01730534

Published
2019
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16. Dapagliflozin and cardiovascular outcomes in type 2 diabetes

Author

Wiviott, S, Raz, I, Bonaca, M, Mosenzon, O, Kato, E, Cahn, A, Silverman, M, Zelniker, T, Kuder, J, Murphy, S, Bhatt, D, Leiter, L, Mcguire, D, Wilding, J, Ruff, C, Nilsson, G, Fredriksson, M, Johansson, P, Langkilde, A, Sabatine, M, Bansilal, S, Furtado, R, Fish, M, Gabovitch, D, Jevne, A, Ahern, S, Im, K, Goodrich, E, Lowe, C, Fisher, N, Gannon, J, Trindade, S, Towarowski, A, Fox, Y, Johnsson, E, Ranft, S, Faber, B, Wallander, M, Weiss, A, Buskila, A, Abola, M, Ardissino, D, Averkov, O, Aylward, P, Bode, C, Bonnici, F, Bonora, E, Budaj, A, Cernea, S, Chiang, C, Cooper, M, Dalby, A, Deerochanawong, C, Dellborg, M, Diaz, R, Dimulescu, D, Eliaschewitz, F, Goudev, A, Hadjadj, S, Herrera, M, Huo, Y, Jermendy, G, Ji, L, Kadowaki, T, Kiss, R, Kooy, A, Kumar, K, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Merlini, P, Nauck, M, Nguyen, T, Nicolau, J, Ostgren, C, Ophuis, T, Padilla, F, Pais, P, Park, K, Parkhomenko, A, Ray, K, Rosenstock, J, Ruda, M, Satman, I, Shestakova, M, Smahelova, A, 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Laszloczky A., Turi T., Rapi J., Pentek Z., Gaal Z., Winkler G., Percs E., Czigany A., Harcsa E., Gurzo M., Tassaly J., Horthy R., Petro G., Farago K., Muller G., Varju I., Kirschner R., Kiss I., Bakai J., Kancz S., Marton Z., Kodur R., Yajnik C., Thomas N., Ayyar V., Iyengar P., Bashkin A., Daoud D., Itzhak B., Katz A., Tsur A., Nikolsky E., Atar S., Grossman A., Klainman E., Tsalihin D., Shotan A., Turgeman Y., Ferrario M., Merlini P., Piatti P., Zenari L., Trevisan R., Bosco B., Di Lorenzo L., Mannucci E., Avogaro A., Reimers B., Trimarco B., Silvestri O., Salvioni A., Nakagawa H., Sueyoshi A., Fukuda K., Yasumoto H., Matsubayashi S., Kawajiri K., Togashi Y., Senokuchi T., Ohta Y., Yamauchi T., Node K., Alcocer Gamba M., Herrera Marmolejo M., De los Rios Ibarra M., Gonzalez Galvez G., Garcia Cantu E., Leguizamo Dimas A., Luna Ceballos R., Medina Pech C., Stobschinski de Alba C., Gonzalez Gonzalez J., Padilla Padilla F., Fanghanel Salmon G., Robles Torres F., Lopez Rosas E., Pelayo Orozco E., Banda Elizondo R., Escalona Caamano A., Frenk Baron P., Aguilar Salinas C., Mustieles Rocha C., Vidrio Velazquez M., Rodriguez Briones I., Saldate Alonso M., Velasco Sanchez R., Groenemeijer B., Ronner E., Kuijper A., Strikwerda S., Van Kempen W., Gijsbers S., Oude Ophuis A., Swart H., Hoogenberg K., Hovens M., van Hessen M., Westerink J., Kragten J., Nierop P., Bax W., Hartong S., Nieuwdorp M., Gonkel F., Al Windy N., Troquay R., Schaafsma H., Lieverse A., Knufman N., Tirador L., Guenon M., Ferrolino A., Atilano A., Aportadera M., Que M., Denopol M., Tolentino M., Jimeno C., Wee J., Mirasol R., Panelo A., Roxas D., Abola M., Palmes P., Silva A., Salvador D., Rosita R., Maravilla L., Rogelio G., Pacheco E., Tin Hay L., Prado J., Krzyzagorska E., Witek R., Miklaszewicz B., Sudnik W., Pomiecko W., Bochenek A., Fares I., Wujkowski M., Korol M., Powierza S., Goch A., Miekus P., Siegel A., Skierkowska J., Romanczuk P., Cygler J., Landa K., Szyprowska E., Stachlewski P., Czerski T., Pawlowicz L., Sowinski D., Romanowski L., Rudzki H., Skorski M., Jasiel-Wojculewicz H., Stasiewski A., Budaj A., Kania G., Mirek-Bryniarska E., Wojnowski L., Korzeniak R., Oh T., Park K., Lee M., Lee K., Jang H., Kim S., Ku B., Cha B., Son H., Lee I., Park J., Yu S., Shon H., Rhee E., Cho J., Park T., Nam J., Pintilei E., Popescu A., Nafornita V., Gutu O., Dumitrescu A., Bala C., Caceaune E., Mindrescu N., Morosanu M., Bradescu O., Munteanu M., Voitec M., Vlaiculescu M., Hancu N., Diaconu Sotropa M., Lupu S., Mateescu A., Carlan L., Marton R., Lupusoru D., Mot A., Coman A., Zaharie D., Rebrov A., Shutemova E., Bolieva L., Khalimov Y., Statsenko M., Galyavich A., Koziolova N., Shapovalova Y., Pavlysh E., Strongin L., Vertkin A., Vishneva E., Pavlova M., Khasanov N., Antsiferov M., Gavrisheva I., Sokolova N., Vorobyev S., Morugova T., Sinitsina I., Ezhov A., Kobalava Z., Belenkiy D., Supryadkina T., Kazakov Y., Oschepkova E., Dreval A., Novikova T., Vishnevsky A., Chizhov D., Akatova E., Vorokhobina N., Ivanov I., Dudinskaya E., Konstantinov V., Kanderkova D., Pavlik L., Raslova K., Paulovic V., Babikova J., Belesova K., Merciakova M., Truban J., Vargova A., Fabryova L., Slovenska M., Plasil R., Tomasova L., Kollarova D., Spodniakova D., Kosikova M., Dzuponova J., Kurcova I., Skripova D., Gabrisova A., Kalinova S., Ranjith N., Burgess L., Mitha I., Conradie M., Distiller L., Pillai P., Pillay S., Horak A., Nethononda R., van den Berg E., Nortje H., Bayat J., Corbett C., Abelson M., van Zyl L., Pillay T., Wing J., Kapp C., Hidalgo Urbano R., Gonzalez Juanatey J., Blanco Coronado J., Bruguera Cortada J., Ferreiro Gutierrez J., Quesada Simon M., Castro A., Delgado Alvarez E., Freixa R., Boada A., Larnefeldt H., Mooe T., Koskinen P., Lagerback P., Linderfalk C., Liu B., Berndtsson Blom K., Tengmark B., Lindholm C., Ostgren C., Oweling M., Albertsson P., Alvarsson M., Fant S., Berglund O., Hsia C., Chiang C., Fang C., Ueng K., Wang K., Lai W., Mamanasiri S., Wongvipaporn C., Kuanprasert S., Thongsri T., Srimahachota S., Boonyavarakul A., Suwanwalaikorn S., Tantiwong P., Sritara P., Sriwijitkamol A., Sanguanwong S., Chotinaiwattarakul C., Piyayotai D., Balci M., Orbay E., Saygili F., Oguz A., Altuntas Y., Comlekci A., Karpenko O., Tkach S., Vlasenko M., Fushtey I., Pertseva T., Reshotko D., Mostovoy Y., Vizir V., Kraiz I., Amosova K., Batushkin V., Tseluyko V., Koval O., Strang C., Bodalia B., Pieters R., Turner W., Asamoah-Owusu N., White C., Calvert J., McNally D., Jones N., McKaig G., Thompson J., Mohr S., Simpson H., Conn P., McCoye A., Rivero O., Yazdani S., Ince C., Zeitlin J., Wharton T., Platt G., Anderson R. J., Angueira-Serrano E., Lillestol M., Hanlon B., Soufer J., Garcia B., Iteld B., Venugopal C., Ahmed A., Duardo-Guerra Y., Jetty P., Miranda A., Wahlen J., Lederman S., Cohen K., Lake L., French W. J., Tahirkheli N., Baker S., Stoltz R., Wilson J., Nadar V., Brown J., Larrain G., Wiseman A., Ruoff G., Williams M., Tan A., Hartman I., Singh N., Graf R., Wakefield P., McNeill R., Byars W., Reyes Almodovar R., Jones S., Kantaros L., Hegedosh N., Graves M., Bernstein M., Falkowski S., Bialow M., Paraschos A., Dagher G., Arif A., Condit J., Chaykin L., Grunstra B., Earl J., Unks D., Srivastava S., Benson M., Huffman C., Miller G., Willis J., Bender K., Martin E., Blackmore R., Rohr K., Chilka S., Gadowski G., Fitz-Patrick D., Benjamin S., Morin D., Zias Dilena A., Acosta R., Claassen D., Miranda F., Raad G., Inzerello A., Porter J., Bhattacharya A., Gutmann J., Korpas D., Syed M., Zieve F., Raisinghani A., Alam S., Bartkowiak A., Boccalandro F., Talano J., Mercado A., Krichmar P., Oldfield C., Adams K., Gorman T., Lewis D., Shah R., Shockey G., Lefebvre G., Andrawis N., Tami L., Bittar N., Khan M. S., Rink L., Hendrix E., Wood J., Robinson J., Pavon H., Irfan M., Gonzalez E., Singal R., Shore K., Saba F., Bianco J., Erickson B., Gorson D., Puri S., Arauz-Pacheco C., Forman S., Akyea-Djamson A., Lieber I., Barker B., Desai P., Sotolongo C., Steinhoff J., Hill R., Radin M., Patel R., Lieberman S., Wenocur H., Dagogo-Jack S., Lupovitch S., Ison R., Bacharach J. M., Diogo J., Mazzella M., Greenwald J., Quadrel M., Mayer N., Datu J., McCartney M., Bruce T., Singal D., Turner J., Videau B., Fritz R., Fox D., Calatayud G., Sheldon W., Kereiakes D., Thomas J., Salacata A., McCullum K., Harris B., de Souza J., Rahman A., Blumenthal S., Narayan P., Bloch M., Augenbraun C., Bernstein R., Perlman R., Berman J., LaBryer L., Wynne A., Fish J., Zarich S., Gabra N., Popeil L., Hermany P., Barreto A., Pomposini D., Gonzalez-Campoy J. M., Langer M., Bayron C., Suneja R., Kamlet J., Wheeler K., Hurley S., Sharma S., Wefald F., Hershon K., O'Connor T., Pueblitz G., Laguerre J., Amin M., Alfonso T., Jaffrani N., Isserman S., Portnay E., Vlastaris A., Dy J., Hagan M., Noveck H., Kraft P., Andersen J., Foley B., Carr K., Gelormini J., Williams T., Landau C., Richwine R., Thakkar M., Karim A., Madhun Z., Francyk D., Lamantia J., Baker B., Zhang W., Lev V., Hasan M., Captain A., Herzog W., Friedman K., Lawson W., Desai V., Ow C., Simons R., Mandviwala M., Le T., Hack T., Zebrack J., Henderson D., DeJulia J., Mehta R., Reza S., Poonawala R., Awad A., Velasquez M., Mohiuddin S., Salazar Sharma M., Myrick G., Gottlieb D., Ovalle F., Alfieri A., Ahmed S., Bohula E., Donahoe S. M., Longshaw K., Eshaghian S., Lash J., Goldberg R. K., Fox B., Mostel E., Dobies D., Ward H., Burbano J., Puleo P., Lenhard M. J., Korn D., Thadani U., Bradley A., Kmetzo J., Heasley E., Raikhel M., Mahr N., Bittar G., Fuentes F., Raghu P., Diep T. T. B., Tran Q. K., Tran N., Nguyen D., and Nguyen V.

Abstract

BACKGROUND The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to ≥60 ml per minute per 1.73 m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], ≥1.3; P≥0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P = 0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P = 0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87)

Published
2019

17. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Bosi E., Choudhary P., de Valk H. W., Lablanche S., Castaneda J., de Portu S., Da Silva J., Re R., Vorrink-de Groot L., Shin J., Kaufman F. R., Cohen O., Laurenzi A., Caretto A., Slatterly D., Henderson-Wilson M., Weisnagel S. J., Dube M. -C., Julien V. -E., Trevisan R., Lepore G., Bellante R., Hramiak I., Spaic T., Driscoll M., Borot S., Clergeot A., Khiat L., Hammond P., Ray S., Dinning L., Tonolo G., Manconi A., Ledda M. S., de Ranitz W., Silvius B., Wojtusciszyn A., Farret A., Vriesendorp T., Immeker-de Jong F., van der Linden J., Brink H. S., Alkemade M., Schaepelynck-Belicar P., Galie S., Treglia C., Benhamou P. -Y., Haddouche M., Hoogma R., Leelarathna L., Shaju A., James L., Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Bosi E., Choudhary P., de Valk H. W., Lablanche S., Castaneda J., de Portu S., Da Silva J., Re R., Vorrink-de Groot L., Shin J., Kaufman F. R., Cohen O., Laurenzi A., Caretto A., Slatterly D., Henderson-Wilson M., Weisnagel S. J., Dube M. -C., Julien V. -E., Trevisan R., Lepore G., Bellante R., Hramiak I., Spaic T., Driscoll M., Borot S., Clergeot A., Khiat L., Hammond P., Ray S., Dinning L., Tonolo G., Manconi A., Ledda M. S., de Ranitz W., Silvius B., Wojtusciszyn A., Farret A., Vriesendorp T., Immeker-de Jong F., van der Linden J., Brink H. S., Alkemade M., Schaepelynck-Belicar P., Galie S., Treglia C., Benhamou P. -Y., Haddouche M., Hoogma R., Leelarathna L., Shaju A., and James L.

Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic even

Published
2019

19. Strawberry and cranberry polyphenols improve insulin sensitivity in insulin-resistant, non-diabetic adults: a parallel, double-blind, controlled and randomised clinical trial

Author

Paquette, Martine, primary, Medina Larqué, Ana S., additional, Weisnagel, S. J., additional, Desjardins, Yves, additional, Marois, Julie, additional, Pilon, Geneviève, additional, Dudonné, Stéphanie, additional, Marette, André, additional, and Jacques, Hélène, additional

Published
2017
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28. Decreased fasting and oral glucose stimulated C-peptide in nondiabetic subjects with sequence variants in the sulfonylurea receptor 1 gene.

Author

Weisnagel, S. John, Weisnagel, S J, Rankinen, T, Nadeau, A, Rao, D C, Chagnon, Y C, Pérusse, L, and Bouchard, C

Subjects
*GENETIC polymorphisms, *GLUCOSE, *METABOLISM
Abstract

The high-affinity sulfonylurea receptor 1 (SUR1) plays an important role in regulating insulin secretion. In the Québec Family Study, we genotyped 731 individuals (685 nondiabetic [ND] subjects) for the SUR1 gene IVS15-3c-->t and exon 18 Thr759(ACC-->ACT) polymorphisms using polymerase chain reaction-restriction fragment-length polymorphism analysis. Phenotypes measured were fasting plasma glucose (GLU), fasting plasma insulin (INS), and fasting C-peptide (CPEP), as well as oral glucose tolerance test (OGTT) responses; they were adjusted for age, sex, waist circumference, and the sum of six skinfold thicknesses. In ND subjects, exon 18 Thr759(ACC-->ACT) T allele carriers (T+) had lower CPEP (P = 0.022, -12.8%) and acute C-peptide responses (area above basal in first 30 min [CP30]) (P = 0.051, -12.4%) than noncarriers (T-). Also, in those with the cT/tC haplotype (from both IVS15-3c-->t and exon 18 Thr759[ACC-->ACT] polymorphisms), CPEP (P = 0.005, -21.2%), CP30 (P = 0.034, -19.2%), and total C-peptide responses (P = 0.016, -20.2%) were lower than that in cT- subjects. In overweight individuals (BMI >25 kg/m2), differences between carriers and noncarriers of the T or cT alleles were greater for GLU (P = 0.023-0.034), CPEP (P = 0.021-0.015), acute OGTT insulin response (P = 0.014-0.019), and CP30 (P = 0.034-0.019). These results suggest that the T and cT allele variants are associated with lower insulin secretion parameters, particularly in female and overweight subjects, adding evidence to the role of SUR1 sequence variants in decreased insulin secretion. [ABSTRACT FROM AUTHOR]

Published
2001
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29. EFFECTS OF EXERCISE TRAINING ON GLUCOSE HOMEOSTASIS.

Author

Boule, N. G., Weisnagel, S. J., and Lakka, T. A.

Subjects
*PHYSICAL education, *EXERCISE, *HOMEOSTASIS, *HYPOGLYCEMIC agents, *GLUCOSE tolerance tests, *DIAGNOSIS of diabetes
Abstract

This article presents a study to determine the effect of exercise training on glucose homeostasis. It has been suggested that physical training leads to transient improvements in insulin sensitivity or glucose tolerance but that these changes return to pre-training levels within a few days. An intravenous glucose tolerance test was performed before and after a standardised training programme. Insulin sensitivity increased by 10%, fasting insulin concentration increases were transitory, and glucose disappearance index increased.

Published
2005

30. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Author

Haddouche, Aini, Bellanne‐Chantelot, Christine, Rod, Anne, Fournier, Luc, Chiche, Laurence, Gautier, Jean‐Francois, Timsit, José, Laboureau, Sandrine, Chaillous, Lucy, Valero, Rene, Larger, Etienne, Jeandidier, Nathalie, Wilhelm, Jean‐Marie, Popelier, Marc, Guillausseau, Pierre‐Jean, Thivolet, Charles, Lecomte, Pierre, Benhamou, Pierre‐Yves, Reznik, Yves, Bosi, Emanuele, Choudhary, Pratik, De Valk, Harold, Lablanche, Sandrine, Castaneda, Javier, De Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine, Cohen, Ohad, Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette, Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Institut National de l'Environnement Industriel et des Risques (INERIS), Service de Chirurgie digestive [Bordeaux], CHU Bordeaux [Bordeaux], Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition, Hôpital Laennec, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Pharmacologie Endocrinienne, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université de Liège, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Dipartimento di Biologia Evoluzionistica 'Leo Pardi', Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), King's College Hospital (KCH), University Medical Center [Utrecht], Medtronic Bakken Research Center BV, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Human Computer Technology Laboratory (HCTLab), Universidad Autonoma de Madrid (UAM), Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute of Child Health, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Endocrinologie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lariboisière, Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF), Università degli Studi di Firenze [Firenze], Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Service de diabétologie - endocrinologie [Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz-Université de Franche-Comté (UFC), Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Bosi, E., Choudhary, P., de Valk, H. W., Lablanche, S., Castaneda, J., de Portu, S., Da Silva, J., Re, R., Vorrink-de Groot, L., Shin, J., Kaufman, F. R., Cohen, O., Laurenzi, A., Caretto, A., Slatterly, D., Henderson-Wilson, M., Weisnagel, S. J., Dube, M. -C., Julien, V. -E., Trevisan, R., Lepore, G., Bellante, R., Hramiak, I., Spaic, T., Driscoll, M., Borot, S., Clergeot, A., Khiat, L., Hammond, P., Ray, S., Dinning, L., Tonolo, G., Manconi, A., Ledda, M. S., de Ranitz, W., Silvius, B., Wojtusciszyn, A., Farret, A., Vriesendorp, T., Immeker-de Jong, F., van der Linden, J., Brink, H. S., Alkemade, M., Schaepelynck-Belicar, P., Galie, S., Treglia, C., Benhamou, P. -Y., Haddouche, M., Hoogma, R., Leelarathna, L., Shaju, A., and James, L.

Subjects
Adult, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, glucose, hemoglobin A1c, insulin, antidiabetic agent, 030209 endocrinology & metabolism, Low insulin, law.invention, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Type 1 diabetes, Continuous glucose monitoring, business.industry, Middle Aged, medicine.disease, Hypoglycemia, 3. Good health, Diabetes Mellitus, Type 1, Hypoglycaemia unawareness, Female, Open label, business
Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect −2·9 [95% CI −3·5 to −2·3]; p

Published
2019
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31. An explained variance-based genetic risk score associated with gestational diabetes antecedent and with progression to pre-diabetes and type 2 diabetes: a cohort study.

Author

Cormier H, Vigneault J, Garneau V, Tchernof A, Vohl MC, Weisnagel SJ, and Robitaille J

Subjects
Adult, Alleles, Body Mass Index, Canada epidemiology, Cohort Studies, Diabetes Mellitus, Type 2 epidemiology, Diabetes Mellitus, Type 2 prevention & control, Diabetes, Gestational epidemiology, Disease Progression, Female, Gene Frequency, Genetic Predisposition to Disease epidemiology, Genotype, Glucose Tolerance Test, Humans, Polymorphism, Single Nucleotide, Pregnancy, Prevalence, Risk Factors, Diabetes Mellitus, Type 2 genetics, Diabetes, Gestational genetics, Genetic Predisposition to Disease genetics
Abstract

Objective: To determine whether an explained-variance genetic risk score (GRS), with 36 single nucleotide polymorphisms (SNPs) previously associated with type 2 diabetes (T2D), is also associated with gestational diabetes mellitus (GDM), and with the progression to pre-diabetes and T2D among women with prior GDM., Design: A cohort study., Setting: Clinical investigation unit of Laval University, Quebec, Canada., Population: A cohort of 214 women with prior GDM and 82 controls recruited between 2009 and 2012., Methods: Associations between the GRS and GDM., Main Outcomes Measures: GDM and prevalence of pre-diabetes and T2D., Results: Women with prior GDM had a higher GRS compared with controls (38.6 ± 3.9, 95% CI 38.1-39.1, versus 37.4 ± 3.2, 95% CI 36.7-38.1; P < 0.0001). In women with prior GDM, the explained-variance GRS was higher for pre-diabetic women compared with women who remained normoglucotolerant at testing (1.21 ± 0.18, 95% CI 1.18-1.23, versus 1.17 ± 0.15, 95% CI 1.13-1.20; P < 0.0001). Similarly, women with T2D had a higher explained-variance GRS compared with women with prior GDM who remained normoglucotolerant (1.20 ± 0.18, 95% CI 1.14-1.25, versus 1.17 ± 0.17, 95% CI 1.13-1.20; P < 0.0001). The predictive effects of the explained-variance GRS, age, and body mass index (BMI), or the additive effects of the three variables, were tested for pre-diabetes and T2D. We observed an area under the curve of 0.6269 (95% CI 0.5638-0.6901) for age and BMI, and adding the explained-variance GRS into the model increased the area to 0.6672 (95% CI 0.6064-0.7281) for the prediction of pre-diabetes., Conclusions: An explained-variance GRS is associated with both GDM and progression to pre-diabetes and T2D in women with prior GDM., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Published
2015
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32. The Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) scale: predictive validity and reliability.

Author

Brazeau AS, Mircescu H, Desjardins K, Dubé MC, Weisnagel SJ, Lavoie C, and Rabasa-Lhoret R

Subjects
Adult, Aged, Body Mass Index, Canada epidemiology, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 psychology, Female, Glycated Hemoglobin metabolism, Humans, Male, Middle Aged, Psychometrics, Reproducibility of Results, Young Adult, Diabetes Mellitus, Type 1 epidemiology, Exercise psychology, Sedentary Behavior, Surveys and Questionnaires
Abstract

Aim: Perceived barriers are one determinant of physical activity. Depending on the study population, these barriers can vary. The aim of this study was to assess the reliability and predictive validity of the 'Barriers to Physical Activity in Type 1 Diabetes' (BAPAD-1) scale, developed by Dubé et al., Methods: A total of 77 adults (48% women; age: 43.5±10.4; body mass index: 25.2±4.3kg/m(2); HbA(1c): 7.6±1.3%) with type 1 diabetes completed the questionnaire and an evaluation of their physical activity using an accelerometer (8.4±1.2 days) and cardiorespiratory fitness assessment (VO(2)(peak)). To evaluate the temporal stability of the questionnaire, a subgroup of 17 participants answered the BAPAD-1 scale on both visits required by the protocol (10±4 days)., Results: The BAPAD-1 scale showed good internal validity with an inter-items correlation coefficient (Cronbach's correlation) of 0.85. The intraclass correlation coefficient for the two times the scales were completed was 0.80. The BAPAD-1 score was negatively correlated with both physical activity energy expenditure (r=-0.25; P=0.03) and VO(2)(peak) adjusted for gender and age (r=-0.27; P=0.02)., Conclusion: The BAPAD-1 scale is a reliable and valid tool for assessing salient barriers to physical activity. In future, this scale could be used to describe the factors accounting for physical activity, and for planning interventions aimed at promoting physical activity among adults with type 1 diabetes., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Published
2012
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33. Relationship of mid-thigh adiposity to the metabolic syndrome in postmenopausal women.

Author

Dubé MC, Lemieux S, Piché ME, Corneau L, Bergeron J, Riou ME, and Weisnagel SJ

Subjects
Aged, Anthropometry, Biomarkers blood, Body Composition physiology, Female, Glucose Clamp Technique, Glucose Tolerance Test, Hemodynamics, Humans, Inflammation blood, Lipids blood, Lipoproteins blood, Middle Aged, Tomography, X-Ray Computed, Adiposity physiology, Metabolic Syndrome pathology, Postmenopause physiology, Thigh anatomy & histology, Thigh pathology
Abstract

Background: In postmenopausal women, a population at risk for the metabolic syndrome, the relative contribution of central fat versus peripheral muscle fat to the metabolic risk profile is unknown. This study explored the relationship between muscle fat infiltration derived from computed tomography (CT) scans and metabolic syndrome., Methods: Mid-thigh CT scans measured the surface of muscle with low attenuation (LAMS) [0-34 Hounsfield units (HU)], which represented the specific component of fat-rich muscle. Insulin sensitivity was evaluated by an euglycemic-hyperinsulinemic clamp. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria were used to determine the presence of the metabolic syndrome., Results: A total of 103 postmenopausal women were studied. Metabolic syndrome was found in 43 women with significantly higher levels of abdominal adiposity, higher LAMS (27 +/- 8 vs. 23 +/- 7 cm(2)), and lower insulin sensitivity compared to those without the metabolic syndrome. Women with higher levels of LAMS presented higher metabolic risk features such as higher blood pressure, abdominal adiposity, inflammatory markers, and blood lipid levels. LAMS and visceral adipose tissue correlated significantly with the presence of metabolic syndrome, but these relationships were lost when LAMS was adjusted for visceral adipose tissue but not when visceral adipose tissue was adjusted for LAMS., Conclusions: These results suggest that postmenopausal women who present with metabolic syndrome had increased fat-rich mid-thigh muscle. Moreover, women with more fat-rich muscle had many features of the metabolic syndrome. These relations were weakened when visceral adipose tissue was taken into account suggesting that LAMS may play a relatively smaller role, compared to VAT, in the contribution to the metabolic syndrome.

Published
2010
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34. Validation of a simple index (SIisOGTT) of insulin sensitivity in a population of sedentary men.

Author

Pigeon E, Riou ME, St-Onge J, Couillard E, Tremblay A, Marette A, Weisnagel SJ, and Joanisse DR

Subjects
Adult, Algorithms, Blood Glucose analysis, Body Mass Index, Glucose Clamp Technique statistics & numerical data, Humans, Insulin blood, Insulin pharmacology, Male, Middle Aged, Obesity blood, Obesity physiopathology, Statistics as Topic, Time Factors, Glucose Tolerance Test statistics & numerical data, Insulin Resistance physiology, Sedentary Behavior
Abstract

Aim: The ongoing obesity epidemic is associated with numerous health problems related to altered metabolic function. Among these is type 2 diabetes, characterized by lowered insulin sensitivity (IS). Consequently, the development of simple indices to assess IS has research and clinical importance. The SI(is)OGTT, a new index of IS, was recently described by Bastard et al. (Diabetes & Metabolism 2007;33:261-8), and validated in sedentary, non-diabetic, overweight and obese postmenopausal women. The aim of the present study was to validate the index in men., Methods: The data used in this project came from sedentary men (n=36), aged 34-53 years, all of whom underwent a hyperinsulinaemic-euglycaemic clamp and 2-hour oral glucose tolerance test (OGTT). Correlations with M/I (glucose infusion rate [GIR] divided by insulin concentration), GIR and GIR divided by fat-free mass (FFM) were obtained by four well-known indices (HOMA, QUICKI, Cederholm and Matsuda) as well as with the new SI(is)OGTT index. Pearson correlations and Bland-Altman analyses were obtained for every index versus clamp value., Results: The best correlate of IS in the present study was the SI(is)OGTT (r=0.84, P<0.0001). The agreement of this method with the hyperinsulinaemic-euglycaemic clamp, as assessed by Bland-Altman plots, was similar to those of the other indices and to those previously described in postmenopausal women., Conclusion: The new index proposed by Bastard et al. is as good a predictor of IS in sedentary men as the other commonly used indices, and appears to be as reliable in this population as it was in the original study of postmenopausal women.

Published
2009
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35. Evidence for interaction between PPARG Pro12Ala and PPARGC1A Gly482Ser polymorphisms in determining type 2 diabetes intermediate phenotypes in overweight subjects.

Author

Ruchat SM, Weisnagel SJ, Vohl MC, Rankinen T, Bouchard C, and Pérusse L

Subjects
Adult, Blood Glucose genetics, Blood Glucose metabolism, Body Mass Index, Diabetes Mellitus, Type 2 metabolism, Female, Genetic Predisposition to Disease, Genotype, Glucose Tolerance Test, Humans, Insulin blood, Insulin genetics, Male, Middle Aged, Overweight genetics, Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alpha, Phenotype, Reverse Transcriptase Polymerase Chain Reaction, Diabetes Mellitus, Type 2 genetics, Heat-Shock Proteins genetics, PPAR gamma genetics, Polymorphism, Genetic genetics, Transcription Factors genetics
Abstract

Background: The peroxisome proliferator-activated receptor-gamma ( PPARG) Pro12Ala and the PPARG co-activator-1alpha ( PPARGC1A) Gly482Ser polymorphisms (SNPs) have been associated with type 2 diabetes mellitus (T2DM) risk. We hypothesized that independent and interactive effects of the PPARG Pro12Ala and PPARGC1A Gly482Ser polymorphisms influence T2DM intermediate phenotypes., Material and Methods: PPARG Pro12Ala and PPARGC1A Gly482Ser SNPs were studied in 680 non diabetic subjects who underwent a 75 g oral glucose tolerant test (OGTT). Glucose and insulin plasma levels in the fasting state and derived from the OGTT were included in the present study., Results: We found significant independent effects of the PPARG and PPARGC1A variants on fasting insulin levels (p=0.02 for both), HOMA-IR (p=0.03 and p=0.02, respectively), insulin area under the curve (AUC) (p=0.007 and p=0.006, respectively) and 2-h glucose levels (p=0.02 for PPARGC1A). Furthermore, significant gene-gene interactions were found for fasting insulin, HOMA-IR and insulin AUC (p=0.03 for all). Carriers of the PPARGC1A Gly allele who were also PPARG Ala-carriers had higher fasting insulin levels (p=0.02), HOMA-IR (p=0.01) and insulin AUC (p=0.01) compared to the Ser/Ser-Ala+genotype combination, whereas no differences between the PPARGC1A genotypes among the PPARG Pro/Pro carriers were observed., Conclusion: Together, these results showed that PPARG Pro12Ala and PPARGC1A Gly482Ser variants are associated, alone and in interaction, with insulin and glucose homeostasis and suggest that gene-gene interactions should be taken into account in candidate gene studies of T2DM to identify subjects with markedly different risks of developing the disease., (J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart New York.)

Published
2009
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36. Is early and late post-meal exercise so different in type 1 diabetic lispro users?

Author

Dubé MC, Weisnagel SJ, Prud'homme D, and Lavoie C

Subjects
Adult, Blood Glucose metabolism, Diabetes Mellitus, Type 1 blood, Female, Glucagon blood, Humans, Hypoglycemia blood, Insulin blood, Insulin therapeutic use, Insulin Lispro, Male, Time Factors, Diabetes Mellitus, Type 1 drug therapy, Exercise physiology, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Postprandial Period physiology
Abstract

To compare blood glucose (BG) responses during a 60 min moderate intensity exercise session performed in early or late postprandial periods. Nine generally well-controlled (HbA(1c): 7.3+/-0.1%) type 1 diabetic patients performed, at least one week apart, two exercise sessions, 60 (early exercise) and 180 min (late exercise) after a standardized breakfast. All subjects were using Humulin N (N) and Humalog (Lispro, LI) insulin. During exercise, the overall decrease in BG was 4.8+/-0.6 mmol/l and 3.6+/-0.8 mmol/l in early and late exercise, respectively (P=0.051). To prevent hypoglycemia, a dextrose infusion was initiated when BG reached 5 mmol/l. The quantity of dextrose infused was 6.2+/-3.0 g and 10.5+/-3.2g in early and late exercise, respectively (NS). The time free of dextrose infusion during exercise was 41.2+/-7.8 min and 31.7+/-7.5 min in early and late exercise, respectively (NS). In N-LI users, overall drop in BG during exercise tends to be greater in the early postprandial period. However, early and late exercise present similar quantity of dextrose infused and time free of dextrose infusion. Consequently, the similar risk of exercise-induced hypoglycemia suggests similar precautions in either exercise times.

Published
2006
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37. Physical activity barriers in diabetes: development and validation of a new scale.

Author

Dubé MC, Valois P, Prud'homme D, Weisnagel SJ, and Lavoie C

Subjects
Attitude to Health, Diabetes Mellitus, Type 1 psychology, Diabetes Mellitus, Type 1 rehabilitation, Exercise psychology, Female, Health Status, Humans, Internal-External Control, Male, Pilot Projects, Reproducibility of Results, Surveys and Questionnaires, Diabetes Mellitus, Type 1 physiopathology, Exercise physiology, Motor Activity
Abstract

To develop and validate a questionnaire measuring perceived Barriers to Physical Activity in Diabetes (type 1) or BAPAD1. Initially, an open-ended questionnaire was filled by 36 patients. The modal accessible beliefs obtained on this pilot study were analysed and a scale composed of 12 items (BAPAD1) was developed and validated. Seventy-four type 1 diabetic patients filled the BAPAD1 scale. Cronbach alpha coefficient was 0.85 and the correlation between the test-retest scores was 0.84, both indicating adequate reliability of the barriers scale. Each item of BAPAD1 scale displayed very good item characteristic curve except for item 12, which was withdrawn. The test reliability curve indicated that the BAPAD1 scale is informative (value>or=0.82) at all levels of perceived barriers toward physical activity. Moreover, among diabetic-related items, the risk of hypoglycemia showed a particularly good item characteristic curve. In summary, the BAPAD1 scale presents excellent psychometric proprieties and among diabetic-related items, the risk of hypoglycemia should be considered as a significant target to overcome in order to increase physical activity. This new validated tool should be useful in identifying the most salient barriers toward the practice of physical activity and thus, permit more focused intervention in order to overcome those barriers.

Published
2006
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38. Interactions among the glucocorticoid receptor, lipoprotein lipase, and adrenergic receptor genes and plasma insulin and lipid levels in the Quebec Family Study.

Author

Ukkola O, Pérusse L, Weisnagel SJ, Bergeron J, Després JP, Rao DC, and Bouchard C

Subjects
Area Under Curve, Cohort Studies, Epistasis, Genetic, Female, Genetic Markers, Genotype, Humans, Insulin metabolism, Lipid Metabolism, Lipoproteins blood, Male, Phenotype, Polymerase Chain Reaction, Polymorphism, Genetic genetics, Quebec, Receptors, Adrenergic, alpha-2 genetics, Receptors, Adrenergic, beta-2 genetics, Insulin blood, Lipids blood, Lipoprotein Lipase genetics, Receptors, Adrenergic genetics, Receptors, Glucocorticoid genetics
Abstract

The aim of the study was to investigate the possible interactions among the glucocorticoid receptor (GRL), lipoprotein lipase (LPL), and adrenergic receptor (ADR) genes on plasma insulin and lipid levels. The study was cross-sectional and based on 742 individuals from phase 2 of the Quebec Family Study (QFS) cohort. Gene markers were identified by Southern blot analysis or polymerase chain reaction (PCR). Plasma glucose and insulin in the fasted state and during an oral glucose tolerance test (OGTT) were determined and insulin and glucose areas were computed. Triglyceride (TG) and cholesterol concentrations in plasma and lipoprotein fractions were determined enzymatically. The results show that GRL and LPL variants had independent effects on plasma high-density lipoprotein cholesterol (HDL-C) and two beta2-ADR variants were related to total cholesterol concentrations. The alpha2-ADR gene Dral polymorphism was the only variant that had an independent effect on the plasma insulin area. Gene-gene interaction effects were found between GRL and alpha2-ADR genes for low-density lipoprotein cholesterol ([LDL-C] P = .013) and between GRL and LPL genes for HDL-C (P = .045). Higher-order interaction effects involving GRL, LPL, and ADR markers were observed for the plasma insulin area (P = .001 to .025) but not the glucose area. After correction for multiple tests, the findings remained essentially unchanged for the insulin area but became nonsignificant for the lipid phenotypes. In conclusion, multiple interactions among GRL, LPL, and ADR gene markers contribute to insulin metabolism and perhaps to lipid levels, while no significant effect is found for each gene separately. The LPL locus appears to determine the pattern of interactions with ADR and GRL loci. These results suggest that gene-gene interaction effects could play a role in the etiology of risk factors for common chronic diseases.

Published
2001
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39. The human obesity gene map: the 2000 update.

Author

Pérusse L, Chagnon YC, Weisnagel SJ, Rankinen T, Snyder E, Sands J, and Bouchard C

Subjects
Animals, Chromosome Mapping, Humans, Mutation genetics, Quantitative Trait, Heritable, Genome, Human, Obesity genetics
Abstract

This report constitutes the seventh update of the human obesity gene map incorporating published results up to the end of October 2000. Evidence from the rodent and human obesity cases caused by single-gene mutations, Mendelian disorders exhibiting obesity as a clinical feature, quantitative trait loci uncovered in human genome-wide scans and in cross-breeding experiments in various animal models, and association and linkage studies with candidate genes and other markers are reviewed. Forty-seven human cases of obesity caused by single-gene mutations in six different genes have been reported in the literature to date. Twenty-four Mendelian disorders exhibiting obesity as one of their clinical manifestations have now been mapped. The number of different quantitative trait loci reported from animal models currently reaches 115. Attempts to relate DNA sequence variation in specific genes to obesity phenotypes continue to grow, with 130 studies reporting positive associations with 48 candidate genes. Finally, 59 loci have been linked to obesity indicators in genomic scans and other linkage study designs. The obesity gene map reveals that putative loci affecting obesity-related phenotypes can be found on all chromosomes except chromosome Y. A total of 54 new loci have been added to the map in the past 12 months and the number of genes, markers, and chromosomal regions that have been associated or linked with human obesity phenotypes is now above 250. Likewise, the number of negative studies, which are only partially reviewed here, is also on the rise.

Published
2001
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40. Interactions among the alpha2-, beta2-, and beta3-adrenergic receptor genes and obesity-related phenotypes in the Quebec Family Study.

Author

Ukkola O, Rankinen T, Weisnagel SJ, Sun G, Pérusse L, Chagnon YC, Després JP, and Bouchard C

Subjects
Abdomen anatomy & histology, Adipose Tissue anatomy & histology, Adult, Alleles, Body Mass Index, Cohort Studies, Deoxyribonucleases, Type II Site-Specific metabolism, Family Health, Female, Genotype, Homozygote, Humans, Male, Phenotype, Polymorphism, Genetic, Receptors, Adrenergic, beta-3, Obesity genetics, Receptors, Adrenergic, alpha-2 genetics, Receptors, Adrenergic, beta genetics, Receptors, Adrenergic, beta-2 genetics
Abstract

The gene-gene interactions between markers in the alpha2-, beta2-, and beta3-adrenergic receptor (ADR) genes and obesity-related phenotypes were studied in the Quebec Family Study (QFS) cohort. The prevalence of the Arg allele of the Arg16Gly polymorphism in the beta2-ADR gene was higher (49%) in males with a body mass index (BMI) of 35 kg/m2 or higher versus those with a BMI less than 35 kg/m2 (33%; P = .010). The beta2-ADR gene Arg16Gly and Gln27Glu polymorphisms were associated with plasma total and low-density lipoprotein (LDL) cholesterol concentrations. In addition, the homozygotes for the 6.3-kb allele of DraI polymorphism in the alpha2-ADR gene had the lowest mean abdominal subcutaneous fat area (P = .012) and total fat area (P = .003), as well as insulin area, under the curve during an oral glucose tolerance test ([OGTT] P = .004). Several ADR gene-gene interaction effects on abdominal fat distribution and plasma lipids were detected. First, significant interactions between alpha2- and beta3-ADR genes were observed on total (P = .015) and subcutaneous (P = .004) abdominal fat. Second, interaction effects between alpha2- and beta2-ADR gene variants influenced total, high-density lipoprotein (HDL), and LDL cholesterol concentrations. Finally, there were interactions between markers within the beta2-ADR gene affecting plasma triglyceride concentrations and subcutaneous abdominal fat. From these results, we conclude that polymorphisms in the ADR genes contribute to body fat and plasma lipid variability in men. Gene-gene interactions among the ADR genes contribute to the phenotypic variability in abdominal obesity and plasma lipid and lipoprotein, but not in visceral fat levels.

Published
2000
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41. The human obesity gene map: the 1999 update.

Author

Chagnon YC, Pérusse L, Weisnagel SJ, Rankinen T, and Bouchard C

Subjects
Animals, Crosses, Genetic, Genetic Linkage, Humans, Mutation, Chromosome Mapping, Obesity genetics
Abstract

This report constitutes the sixth update of the human obesity gene map incorporating published results up to the end of October 1999. Evidence from the rodent and human obesity cases caused by single gene mutations, Mendelian disorders exhibiting obesity as a clinical feature, quantitative trait loci (QTL) uncovered in human genome-wide scans and in crossbreeding experiments with mouse, rat, pig and chicken models, association and linkage studies with candidate genes and other markers is reviewed. Twenty-five human cases of obesity can now be explained by variation in five genes. Twenty Mendelian disorders exhibiting obesity as one of their clinical manifestations have now been mapped. The number of different QTLs reported from animal models reaches now 98. Attempts to relate DNA sequence variation in specific genes to obesity phenotypes continue to grow, with 89 reports of positive associations pertaining to 40 candidate genes. Finally, 44 loci have linked to obesity indicators in genomic scans and other linkage study designs. The obesity gene map depicted in Figure 1 reveals that putative loci affecting obesity-related phenotypes can be found on all autosomes, with chromosomes 14 and 21 showing each one locus only. The number of genes, markers, and chromosomal regions that have been associated or linked with human obesity phenotypes continues to increase and is now well above 200.

Published
2000
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