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Titolo:
The Diabetes Prevention Program - Design and methods for a clinical trial in the prevention of type 2 diabetes
Autore:
Bray, GA; Culbert, IW; Champagne, CM; Dawson, L; Eberhardt, B; Greenway, FL; Guillory, FG; Hebert, AA; Jeffirs, ML; Kennedy, BM; Lovejoy, JC; Morris, LH; Melancon, LE; Reed, L; Perault, J; Ryan, DH; Sanford, DA; Smith, KG; Smith, LL; St Amant, JA; Tulley, RT; Vicknair, PC; Williamson, D; Zachwieja, JJ; Polonsky, KS; Matulik, MJ; Clarke, B; DeSandre, C; Ehrmann, DA; Hilbrich, RM; McNabb, WL; Morrone, D; Semenske, AR; Stepp, KA; Tobian, JA; Watson, PG; Caro, JF; Goldstein, BJ; Graziani, CM; Kunkel, EJ; Laine, CA; Louis, DZ; Smith, KA; Spandirfer, J; Yuen, EJ; Goldberg, RB; Rowe, P; Calles, J; Donahue, RP; Florez, HJ; Giannella, A; OHara, P; Prineas, R; Haffner, SM; Montez, MG; Miettinen, H; Mobley, CM; Mykkanen, LA; Hamman, RF; Nash, PV; Calonge, BN; Hill, JO; Jortberg, BT; Regensteiner, JG; Reusch, J; Schiltz, CM; Seagle, H; VanDorsten, B; Horton, ES; Lawton, KE; Arky, RA; Bryant, M; Burke, JP; Caballero, E; Callaphan, KM; Ganda, OP; Franklin, T; Jackson, SD; Jacobsen, AM; Kula, LM; Kocal, M; Malloy, MA; Nicosia, M; Oldmixon, CF; Pan, J; Quitingon, M; Rubtchinsky, S; Seely, EW; Schweizer, D; Simonson, D; Smith, F; Solomon, CG; Warram, J; Kahn, SE; Montgomery, BK; Berger, M; Boyko, EJ; Fujimoto, WY; Greenbaum, CJ; Knopp, RH; McCann, BS; Lipkin, EW; Nguyen, TT; Palmer, JP; Schwartz, RS; Talbot-Lawson, C; Wan, D; Kitabchi, AE; Murphy, ME; Applegate, WB; Bryer-Ash, M; Frieson, SL; Imseis, R; Kennedy, CL; Lambeth, HC; Lichtermann, LC; Oktaei, H; OToole, ML; Rutledge, LMK; Sherman, AR; Smith, CM; Soberman, JE; Williams-Cleaves, BJ; Metzger, BE; Johnson, MK; Fitzgibbon, M; Heard, D; Johnson, CKH; McPherson, D; Molitch, ME; Moore, M; Pitts, T; Schinleber, PA; Nathan, DM; McKitrick, C; Abbott, K; Anderson, E; Cagliero, E; Cohen, M; Crowell, S; Delahanty, L; Levina, E; Michel, T; OKeefe, J; Poulos, A; Ronan, L; Rosal, M; Salerno, M; Shagensky, C; Steiner, B; Young, A; Olefsky, JM; Carrion-Petersen, ML; Barrett-Connor, E; Beltran, M; Caenepeel, K; Edelman, SV; Ford, RO; Garcia, J; Henry, RR; Hill, M; Horne, J; Leos, D; Mudaliar, S; Pollard, A; Torio, J; Pi-Sunyer, FX; Lee, JE; Allison, DB; Aronoff, NJ; Barreras, IM; Crandall, JP; Foo, ST; Orlando, SJ; Parkes, K; Rooney, ES; Van Wye, GEH; Viscovich, KA; Prince, MJ; Kukman, SM; Dotson, YF; Fineberg, ES; Guare, JC; Ignaut, JM; Jackson, MA; Kirkman, MS; Marrero, DG; Porter, DB; Rowland, ND; Wheeler, ML; Ratner, RE; Youssef, G; Bronsord, M; Cheatham, WW; Boggs, G; Evans, C; Levatan, C; Kellum, T; Nair, AK; Passaro, MD; Saad, MF; Khan, A; Aziz, A; Bernaba, B; Budgett, MD; Cosenza, C; Hagar, JE; Isagholian, K; Jinagouda, SD; Kamdar, VV; Kumar, D; Khawaja, Q; Kelada, BL; Lui, G; Marston, AR; Mehta, V; Sharma, AR; Szamos, K; Vargas, A; Vargas, B; Zambrana, N; Dagogo-Jack, S; Santiago, AE; Brendle, JS; Fisher, EB; Gherardini, DC; Heins, JM; Marsala, JM; Raspberry, CC; Santiago, JV; Stephan, CL; Saudek, CD; Bradley, VL; Brancati, FL; Cappelli, S; Charleston, JB; Rubin, RR; Stewart, KJ; Sullivan, E; Schade, DS; Adams, KS; Atler, LF; Bowling, DA; Boyle, PJ; Burge, MR; Canady, JL; Chai, L; Dorin, RI; Facio, E; Guillen, M; Gutierrez, M; Johannes, C; Katz, P; King, C; McCalman, R; Rassam, A; Senter, W; Waters, D; Shamoon, H; Brown, JO; Cox, L; Duffy, H; Engel, S; Friedler, A; Howard-Century, CJ; Longchamp, N; Pompi, D; Walker, EA; Wylie-Rosett, J; Zonszein, J; Wing, RR; Kramer, MK; Barr, S; Clifford, L; Culyba, R; Frazier, M; Harris, L; Harrier, S; Henderson, W; Jeffries, S; Koenning, G; Maholic, K; Mullen, M; Noel, A; Orchard, T; Smith, CF; Smith, M; Viteri, J; Wilson, T; Williams, KV; Zgibor, J; Arakaki, RF; Latimer, RW; Baker-Ladao, NK; Beddow, RM; Dias, LM; Dupont, DA; Fukuhara, LL; Mau, MK; Odom, SK; Perry, RU; Tokunaga, JS; Knowler, WC; Hoskin, MA; Andre, VL; Acton, KJ; Antone, S; Baptisto, NM; Bennett, PH; Bird, EC; Dacawyma, TS; Hanson, RL; Jackson, MC; Jay, PA; Kobus, KM; Roumain, J; Rowse, DH; Roy, RJ; Yazzie, M; Cooeyate, NJ; Chavez, M; Broussard, BA; Ghahate, JM; Hughte, G; Ingraham, LE; Kaskalla, RS; Kessler, D; Nashboo, Y; Poirier, S; Percy, CA; Barber, R; Benson, MB; Duncan, R; Glass, M; Gohdes, D; Grant, W; Horse, E; Morgan, T; Reidy, M; Bain, R; Bambad, J; Brenneman, T; Dunegan, C; Edelstein, SL; Grimes, KL; Jones, S; Jones, TL; Klepac, H; Lachin, JM; Mucik, P; Orlosky, R; Rochon, J; Stimpson, CE; Van Aerden, C; Eastman, R; Garfield, S; Harris, M; Andres, R; Engelgau, M; Narayan, V; Williamson, D; Herman, W; Chandler, WL; Marcovina, SM; McMillan, T; Rautaharju, PM; Rautaharju, FSR; Mayer-Davis, EJ; OLeary, DH; Funk, LRC; OLeary, KA; Scherzinger, AL; Stamm, ER; Gillis, BP; Kriska, AM; Huffmyer, C; Meier, A; Venditti, EM; Wing, RR; Haffner, SM; Ratner, RE; Olefsky, JM; Santiago, JV; Saudek, CD; Knowler, WC; Montez, MG; Fujimoto, WY; Hamman, RF; Nathan, DM;
Indirizzi:
Pennington Biomed Res Ctr, Baton Rouge, LA USA Pennington Biomed Res Ctr Baton Rouge LA USA es Ctr, Baton Rouge, LA USA Univ Chicago, Chicago, IL 60637 USA Univ Chicago Chicago IL USA 60637Univ Chicago, Chicago, IL 60637 USA Jefferson Med Coll, Philadelphia, PA USA Jefferson Med Coll Philadelphia PA USA on Med Coll, Philadelphia, PA USA Univ Miami, Coral Gables, FL 33124 USA Univ Miami Coral Gables FL USA 33124 iv Miami, Coral Gables, FL 33124 USA Univ80309rado, Hlth Sci Ctr, Computed Tomog Scan Reading Unit, Boulder, COUniv Colorado Boulder CO USA 80309 d Tomog Scan Reading Unit, Boulder, CO Joslin Diabet Ctr, Boston, MA USA Joslin Diabet Ctr Boston MA USAJoslin Diabet Ctr, Boston, MA USA Univ Washington, Seattle, WA 98195 USA Univ Washington Seattle WA USA 98195 iv Washington, Seattle, WA 98195 USA Univ Tennessee, Knoxville, TN 37996 USA Univ Tennessee Knoxville TN USA 37996 Tennessee, Knoxville, TN 37996 USA Massachusetts Gen Hosp, Boston, MA 02114 USA Massachusetts Gen Hosp Boston MA USA 02114 Gen Hosp, Boston, MA 02114 USA Univ Calif San Diego, La Jolla, CA 92093 USA Univ Calif San Diego La Jolla CA USA 92093 Diego, La Jolla, CA 92093 USA St Lukes Roosevelt Hosp, New York, NY USA St Lukes Roosevelt Hosp New York NY USA Roosevelt Hosp, New York, NY USA Indiana Univ, Bloomington, IN 47405 USA Indiana Univ Bloomington IN USA 47405 ana Univ, Bloomington, IN 47405 USA Medlantic Res Inst, Washington, DC USA Medlantic Res Inst Washington DC USA lantic Res Inst, Washington, DC USA Univ So Calif, UCLA Sch Med, Los Angeles, CA 90089 USA Univ So Calif Los Angeles CA USA 90089 Sch Med, Los Angeles, CA 90089 USA Washington Univ, St Louis, MO USA Washington Univ St Louis MO USAWashington Univ, St Louis, MO USA Johns Hopkins Sch Med, Baltimore, MD USA Johns Hopkins Sch Med Baltimore MD USA opkins Sch Med, Baltimore, MD USA Univ New Mexico, Sch Med, Albuquerque, NM 87131 USA Univ New Mexico Albuquerque NM USA 87131 h Med, Albuquerque, NM 87131 USA Albert Einstein Coll Med, Bronx, NY USA Albert Einstein Coll Med Bronx NYUSA t Einstein Coll Med, Bronx, NY USA Univ Pittsburgh, Pittsburgh, PA 15260 USA Univ Pittsburgh Pittsburgh PA USA 15260 tsburgh, Pittsburgh, PA 15260 USA Univ Hawaii, Honolulu, HI 96822 USA Univ Hawaii Honolulu HI USA 96822Univ Hawaii, Honolulu, HI 96822 USA NIDDKD, Program Off, Bethesda, MD USA NIDDKD Bethesda MD USANIDDKD, Program Off, Bethesda, MD USA NIA, Bethesda, MD 20892 USA NIA Bethesda MD USA 20892NIA, Bethesda, MD 20892 USA Ctr Dis Control & Prevent, Atlanta, GA USA Ctr Dis Control & Prevent Atlanta GA USA trol & Prevent, Atlanta, GA USA Univ Michigan, Ann Arbor, MI 48109 USA Univ Michigan Ann Arbor MI USA 48109 iv Michigan, Ann Arbor, MI 48109 USA Bowman Gray Sch Med, Epicare Ctr, Winston Salem, NC USA Bowman Gray Sch Med Winston Salem NC USA care Ctr, Winston Salem, NC USA Univ S Carolina, Nutr Coding Ctr, Columbia, SC 29208 USA Univ S Carolina Columbia SC USA 29208 Coding Ctr, Columbia, SC 29208 USA New England Med Ctr, Cent Carotid Ultrasound Unit, Boston, MA USA New England Med Ctr Boston MA USA arotid Ultrasound Unit, Boston, MA USA
Titolo Testata:
DIABETES CARE
fascicolo: 4, volume: 22, anno: 1999,
pagine: 623 - 634
SICI:
0149-5992(199904)22:4<623:TDPP-D>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
IMPAIRED GLUCOSE-TOLERANCE; POLYCYSTIC-OVARY-SYNDROME; INSULIN-RESISTANCE; BLOOD-PRESSURE; METABOLIC ABNORMALITIES; PHYSICAL-ACTIVITY; LONGITUDINAL DATA; PIMA-INDIANS; METFORMIN; MELLITUS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
67
Recensione:
Indirizzi per estratti:
Indirizzo: Bray, GA George Washington Univ, Ctr Biostat, DPP Coordinating Ctr, 6110 Execut Blvd George Washington Univ 6110 Execut Blvd 750 Rockville MD USA 20852
Citazione:
G.A. Bray et al., "The Diabetes Prevention Program - Design and methods for a clinical trial in the prevention of type 2 diabetes", DIABET CARE, 22(4), 1999, pp. 623-634

Abstract

The Diabetes Prevention Program is a randomized clinical trial testing strategies to prevent or delay the development of type 2 diabetes in high-riskindividuals with elevated fasting plasma glucose concentrations and impaired glucose tolerance. The 27 clinical centers in the U.S. are recruiting atleast 3,000 participants of both sexes, similar to 50% of whom are minority patients and 20% of whom are greater than or equal to 65 years old, to beassigned at random to one of three intervention groups. an intensive lifestyle intervention focusing on a healthy diet and exercise and two masked medication treatment groups-metformin or placebo-combined with standard diet and exercise recommendations. Participants are being recruited during a 2 2/3-year period, and all will be followed for an additional 3 1/3 to 5 yearsafter the close of recruitment to a common closing dare in 2002. The primary outcome is the development of diabetes, diagnosed by fasting or post-challenge plasma glucose concentrations meeting the 1997 American Diabetes Association criteria. The 3,000 participants will provide 90% power to detect a 33% reduction in an expected diabetes incidence rate of at least 6.5% peryear in the placebo group. Secondary outcomes include cardiovascular disease and its risk factors; changes in glycemia, beta-cell function, insulin sensitivity obesity diet, physical activity and health-related quality; of life: and occurrence of adverse events. A fourth treatment group troglitazone combined with standard diet and exercise recommendations-was included initially but discontinued because of the liver toxicity of the drug. This randomized clinical trial will test the possibility of preventing or delaying the onset of type 2 diabetes in individuals at high risk.

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Documento generato il 05/12/20 alle ore 01:02:04