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23. Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

Author

James, Wp, Caterson, Id, Coutinho, W, Finer, N, VAN GAAL LF, Maggioni, Ap, TORP-PEDERSEN, C, Sharma, Am, Shepherd, Gm, Rode, Ra, Renz, Cl, Van Gaal LF, Torp-Pedersen, C, Pepine, C, Pocock, S, Drexler, H, Swedberg, K, Sleight, P, Armstrong, P, Kerr, D, Dagenais, G, Brophy, J, Avezum, A, Bogaty, P, Fabbri, G, Galli, M, Hildebrandt, P, Mann, J, Ostergren, J, Sherman, D, Zannad, F, Colquhoun, D, Hollanders, G, e Forti A, Costa, Cifkova, R, Toubro, S, Ziegler, O, Scherbaum, Wa, Jordan, J, Halmy, L, Ferrannini, E, Santini, F, Gonzalez, C, Narkiewicz, K, Hancu, N, Payer, J, Pascual, J, Wilding, J, Campbell, L, Carey, D, Gerstman, M, Karrasch, J, Lefkovits, J, Marks, J, Marks, S, Moses, R, Phillips, P, Proietto, J, Roberts, D, Roberts-Thomson, P, Shaw, J, Simpson, R, Singh, B, Singleton Jeffries, W, Stuckey, B, Boland, J, Brohet, C, Coucke, F, Dendale, P, Jouret, G, Kolanowski, J, Kutnowski, M, Martens, F, Muls, E, Peiffer, F, Penninckx, H, Scheen, A, Schoors, D, Vaerenberg, M, Van Cleemput, J, Van Crombrugge, P, Van Kuyk, M, Verhaegen, A, Wollaert, B, de Albuquerque DC, Appolinario, J, de Godoy Matos AF, Gross, Jl, Halpern, A, Kerr Saraiva JF, Milagres, R, Repetto, G, Suplicy, Hl, Zanella, Mt, Bednarova, J, Cepelak, V, Cerny, P, Hainer, V, Havranek, P, Homza, M, Jansa, P, Karlicek, M, Kolesar, J, Kotik, I, Kucera, D, Kuchar, J, Kunc, M, Kvapil, M, Linhart, A, Machova, V, Matuska, J, Oral, I, Pavlas, J, Pesatova, S, Povolny, J, Semrad, B, Smetana, K, Soucek, M, Svacina, S, Tesinsky, P, Urbanek, R, Wasserburger, B, Zachoval, R, Zahumensky, E, Zidkova, E, Astrup, A, Dominguez, H, Faber, J, Hilderbrant, P, Kober, L, Perrild, H, Richelsen, B, Sogaard, P, Svendsen, Ol, Urhammer, S, Archambeaud, F, Basdevant, A, Borys, Jm, Bringer, J, Brunetiere, C, Charpentier, G, Cocaul-André, M, Dabadie, H, Dubreuil, A, Estour, B, Gautier, Jf, Gibault, T, Halimi, S, Hespel, Jp, Issa Sayegh, M, Krempf, M, Laville, M, Lecerf, Jm, Louvet, Jp, Penfornis, A, Ritz, P, Schlienger, Jl, Schmitt, B, Valensi, P, Baar, M, Beermann, J, Bock, M, Boenner, G, Dammann, Hg, Diehm, C, Ditschuneit, H, Gadow, J, Gehlhar, S, Gessner, S, Guthersohn, A, Hamann, A, Hanefeld, M, Hasenfuss, G, Herzner, A, Heun, Kc, Heufelder, Ae, Hohensee, H, Jacob, S, Krings, P, Krätzig, B, Krosse, B, Lehmann, Rt, Mindt-Prüfert, S, Maisch, B, Pfeiffer, Af, Richard, F, Rose, B, Schmidt, E, Scholze, J, Schreckenberg, A, Stuebler, P, Walter, J, Wirth, A, Wunderlich, J, Abraham, G, Altorjay, A, Augusztin, G, Csaszar, A, Czuriga, I, Dinnyes, J, Gero, L, Gyimesi, A, Janosi, A, Kovacs, I, Liziczai, I, Majtenyi, A, Medvegy, M, Nadhazi, Z, Pados, G, Polak, G, Ronaszeki, A, Sido, Z, Simon, K, Anzà, C, Bevilacqua, M, Bosello, O, Chiariello, M, Cordera, R, Ferrari, E, Frittitta, L, Giorgino, R, Liuzzi, A, Malinverni, C, Di Mario, U, Melchionda, N, Occhi, G, Perticone, F, Pinchera, A, Pinelli, G, Rovera, G, Santeusanio, F, Urbinati, S, Alpizar-Salazar, M, Carrillo-Ortega, E, Fanghanel Salmon, G, Laviada-Molina, Ha, Madero, Ma, Rodriguez, G, Saldate, C, Sanchez-Castillo, Cp, Violante, Rm, Wacher, N, Zayas-Jaime, Fj, Zuniga-Guajardo, S, Adamiec, R, Banasiak, W, Chrusciel, P, Derlaga, B, Gebala, A, Gessek, J, Janik, K, Janion, M, Kalina, Z, Kozlowski, A, Kusnierz, B, Majcher, Z, Miekus, P, Niegowska, J, Okopien, B, Ostrowska, L, Pasowicz, M, Piepiorka, M, Pluta, W, Polaszewska-Muszynska, M, Ponikowski, P, Pupek-Musialik, D, Sawicki, A, Sobocik, H, Stankiewicz, A, Szpajer, M, Trojnar, R, Tykarski, A, Wrabec, K, Wyrzkowski, B, Zahorska-Markiewicz, B, Zalewski, M, Carrageta, M, Mendes Pedro MM, Parente Martins LM, dos Santos, L, Babes, A, Creteanu, G, Dan, Ga, Dragulescu, Si, Graur, M, Tirgoviste, Ci, Morosanu, M, Mota, M, Paveliu, Fs, Radoi, M, Ranetti, A, Totoian, I, Andre, I, Bugan, V, Cencarik, J, Csala, L, Farsky, S, Gonsorcik, J, Kamensky, G, Kmec, J, Krahulec, B, Kurian, R, Macek, V, Majercak, I, Micko, K, Mokan, M, Riecansky, I, Sojka, G, Uhliar, R, Urgeova, L, Vancik, J, Baro, Fm, Barrios Merino, A, Borras, Jl, Caixas, A, Cuatrecasas Cambra, G, Dominguez Escribano JR, Duran Garcia, S, Escobar-Jimenez, L, Esteva de Antonio, I, Formiguera Sala, X, Garcia-Luna, Pp, Garcia Robles, R, Gonzalez Albarran, O, Hernandez-Mijares, A, Martin Hidalgo, A, Masmiquel Comas, L, Morales Perez, F, Moreno Esteban, B, Pascual Izuel JM, Redon Mas, J, Ricart, W, Rubio, Ma, Ruilope, Lm, Salas-Salvado, J, Terroba Larumbe, M, Tinahones, F, de la Torre Casares ML, Vidal Cortada, J, Zuniga-Perez Lemaur, M, Abdulhakim, Ee, Adler, A, Barnett, Ah, Bodmer, C, Campbell, Iw, Chowdhury, T, Cleland, J, Cook, Rc, Dinneen, S, Donnachie, H, Haslam, Dw, Hillis, Gs, Horne, M, Howarth, Dj, Hughes, E, Jackson, S, Jones, Sc, Jones, Th, Kumar, S, Lean, M, Maroni, J, Mcinnes, G, Middleton, A, Morris, A, Newcombe, G, O'Kane, Kp, Pavel, Ic, Pawa, R, Perry, C, Pitts, C, Raja, A, Reckless, J, Robinson, J, Sarmiento, R, Soo, Sc, Taylor, S, Thomas, Ho, Thomson, Ma, and Wilkins, M.

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Blood Pressure, Kaplan-Meier Estimate, Type 2 diabetes, Klinikai orvostudományok, Placebo, law.invention, Double-Blind Method, Randomized controlled trial, Weight loss, law, Internal medicine, Appetite Depressants, medicine, Humans, Obesity, Myocardial infarction, Stroke, Aged, business.industry, Hazard ratio, Orvostudományok, General Medicine, Middle Aged, Overweight, medicine.disease, Surgery, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Cardiology, Female, Human medicine, medicine.symptom, business, Cyclobutanes, Sibutramine, medicine.drug
Abstract

Background The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. Methods We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). Results The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Conclusions Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)

Published
2010

26. Protein intake and urinary albumin excretion rates in the EURODIAB IDDM Complications Study

Author

Toeller, M, Buyken, A, Heitkamp, G, Brämswig, S, Mann, J, Milne, R, Gries, F. A, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, Mitchell, DAVID ROSS, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Djs, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, Manuel, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, Sivieri, P., R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Henio, Ev, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Vrhovac, V., Toeller, M, Buyken, A, Heitkamp, G, Bramswig, S, Mann, J, Milne, R, Gries, Fa, Keen, H, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Klischan, A, Forst, T, Schumacher, W, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglu, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, and Vrhovac, V

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Urinary system, Physiology, Albuminuria, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Dietary Proteins, Europe, Female, Humans, Middle Aged, Nephropathy, Protein intake, urinary albumin, Diabetic nephropathy, Excretion, Diabetes mellitus, Internal medicine, Diabetes Mellitus, Internal Medicine, Medicine, Proteinuria, business.industry, medicine.disease, Endocrinology, Blood pressure, medicine.symptom, business, Type 1, Kidney disease
Abstract

For people with insulin-dependent diabetes mellitus (IDDM) renal disease represents a life-threatening and costly complication. The EURODIAB IDDM Complications Study, a cross-sectional, clinic-based study, was designed to determine the prevalence of renal complications and putative risk factors in stratified samples of European individuals with IDDM. The present study examined the relationship between dietary protein intake and urinary albumin excretion rate (AER). Food intake was assessed centrally by a standardized 3-day dietary record. Urinary AER was determined in a central laboratory from a timed 24-h urine collection. Complete data were available from 2696 persons with IDDM from 30 centres in 16 European countries. In individuals who reported protein consumption less than 20 % of total food energy intake, mean AER was below 20 μg/min. In those in whom protein intake constituted more than 20 %, mean AER increased, a trend particularly pronounced in individuals with hypertension and/or poor metabolic control. Trends reached statistical significance for intakes of total protein (% of energy, p = 0.01) and animal protein (% of energy, p = 0.02), while no association was seen for vegetable protein (p = 0.83). These findings support the current recommendation for people with diabetes not to exceed a protein intake of 20 % of total energy. Monitoring and adjustment of dietary protein appears particularly desirable for individuals with AER exceeding 20 μg/min (approximately 30 mg/24 h), especially when arterial pressure is raised and/or diabetic control is poor. [Diabetologia (1997) 40: 1219–1226]

Published
1997

27. Repeatability of three-day dietary records in the EURODIAB IDDM Complications Study

Author

Toeller M, Buyken A, Heitkamp G, Milne R, Klischan A, Gries FA, Fuller JH, Keen H, Krans HMJ, Navalesi R, Sjolie AK, Stephenson JM, Viberti GC, Karamanos B, Tountas C, Kofinis A, Petrou K, Katsilambros N, RoussiPenessi D, Cignarelli M, Giorgino R, DeGeco ML, Ramunni I, IonescuTirgoviste C, Strachinariu R, Nicolau A, Tamas G, Kerenyi Z, Ahmed AM, Toth J, Kempler P, Muntoni S, Songini M, Stabilini M, Fossarello M, Pintus S, Ferriss B, Cronin CC, Humphreys M, Forst T, Schumacher W, Wagener W, Venhaus A, Rottiers R, Priem H, Deschoolmeester MJ, Ebeling P, Sinisalo M, Koivisto VA, IdziorWalus B, Solnica B, SzopinskaCiba L, Solnica K, Lemkes HHPJ, Jansen JJ, EltedeWever BM, NunesCorrea J, Boavida J, Carvalho R, Afonso MJ, Monteiro M, David R, Jepson E, McHardyYoung S, Betteridge DJ, Milne M, Thompson T, Michel G, Wirion R, Paquet S, Hornick H, Boulton AJM, Ashe H, Fernando DJS, Curwell J, Pozza G, Slaviero G, Comi G, Fattor B, Marchi M, Mehnert H, Nuber A, Janka H, Nichting M, Standl E, Crepaldi G, Nosadini R, Cathelineau G, Cathelineau BV, Jellal M, Grodner N, Feiss PG, Baclet N, Santeusanio F, Rosi G, Ventura MRM, Cagini C, Marino C, Penno G, Miccoli R, Nannipieri M, Manfredi S, Bertolotto A, Ghirlanda G, Manto A, Cotroneo P, Ward JD, Tesfaye S, Mody C, Rudd C, Papazoglou N, Goutzourela M, Manes C, Molinatti GM, Vitelli F, Porta M, Pagano GF, Estivi P, Sivieri R, Carta Q, Petraroli G, BenSoussan D, Fallas MC, Fallas P, Dhanaeus C, Bourgeois MD, Muggeo M, Cacciatori V, Bellavere F, Galante P, Gemma ML, Branzi P, Irsigler K, Abrahamian H, Gurdet C, Hornlein B, Willinger C, Strohner H, Just M, Walford S, Wardle EV, Henio S, Cooke H, Roglic G, Resman Z, Metelko Z, Skrabalo Z., BANDELLO , FRANCESCO, Toeller, M, Buyken, A, Heitkamp, G, Milne, R, Klischan, A, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Schumacher, W, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Jansen, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Afonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Thompson, T, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Standl, E, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Manto, A, Cotroneo, P, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Papazoglou, N, Goutzourela, M, Manes, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
Dietary Fiber, medicine.medical_specialty, Alcohol Drinking, European community, Saturated fat, Population, Medicine (miscellaneous), the EURODIAB IDDM Study, Diabetes mellitus, Dietary Carbohydrates, medicine, Humans, education, education.field_of_study, Nutrition and Dietetics, business.industry, Reproducibility of Results, Repeatability, medicine.disease, Dietary Fats, Diet Records, Confidence interval, Surgery, Europe, three-day dietary records, Diabetes Mellitus, Type 1, Nutrition Assessment, Quartile, Cohort, Dietary Proteins, Energy Intake, business, Demography
Abstract

Objectives: Repeatability of a dietary method is important in determining the quality of nutritional data. It should be assessed in the population of interest. This study evaluated the repeatability of nutritional data from standardized three-day dietary records, from the clinic-based, cross-sectional multi-centre EURODIAB IDDM Complications Study. Design and Subjects: 15% of the total EURODIAB cohort was randomly selected to test the repeatability of nutritional intake data. Two three-day records, completed three weeks apart, were available for 216 diabetic patients (7.5%) representative of the total cohort. All records were analysed centrally, for intakes of protein (animal and vegetable), fat (saturated fat and cholesterol), carbohydrate, fibre, alcohol and energy. Repeatability was measured comparing mean intakes, determining the proportion of patients classified into the same/opposite quartile by the two three-day records and assessing mean differences with standard deviations (s.d.d). Results: There were no significant differences in mean energy and nutrient intakes between the first and second records. Classification of individuals into the opposite quartile occurred only in 0–4% of patients and overall about 50% (range 44–74%) of the subjects were classified into the same quartiles of intakes. Only small mean differences were found for energy intake (−156 (1633) kJ; 95% confidence limits −375, 63 kJ) and nutrients with s.d.ds comparable to intra-individual variations in the general population. The differences in energy intake were randomly distributed over the range of intakes. Conclusions: The present study demonstrates that standardized three day dietary records show a high degree of repeatability within a short period of time in a sample of European IDDM patients. The good repeatability strengthens the conclusions drawn from the nutritional data in the EURODIAB IDDM Complications Study. Sponsorship: Nutrition Co-ordinating Centre research funds, Diabetes Research Institute at Heinrich-Heine University, Dusseldorf. The EURODIAB IDDM Complications Study was supported by the European Community.

Published
1997

29. Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold

Author

Chaturvedi, Nish, Bandinelli, Simona, Mangili, Ruggero, Penno, Guiseppe, Rottiers, Raoul E., Fuller, John H., Karamanos, B., Kofinis, A., Petrou, K., Giorgino, R., Giorgino, F., Picca, G., Angarano, A., De Pergola, G., Ionescu-Tirgoviste, C., Coszma, A., Songini, M., Casu, A., Pedron, M., Fossarello, M., Ferriss, J. B., Grealy, G., Keefe, D. O., White, A., Cleary, P. E., Toeller, M., Arden, C., Rottiers, R., Tuyttens, C., Priem, H., Ebeling, P., Kylliainen, M., Kyostio-Renvall, T., Idzior-Walus, B., Sieradzki, J., Cyganek, K., Lemkes, H. H. P. J., Roest, C., Nunes-Correa, J., Rogado, M. C., Gardete-Correia, L., Cardoso, M. C., Michel, G., Wirion, R., Cardillo, S., Pozza, G., Mangili, R., Asnaghi, V., Lattanzio, Rosangela, Galardi, G., Standl, E., Schaffler, B., Brand, H., Harms, A., Ben Soussan, D., Verier-Mine, O., Fuller, J. H., Holloway, J., Asbury, L., Betteridge, D. J., Cathelineau, G., Bouallouche, A., Villatte Cathelineau, B., Santeusanio, F., Rosi, G., D’ Alessandro, V., Cagini, C., Navalesi, R., Penno, G., Bandinelli, S., Miccoli, R., Ghirlanda, G., Saponara, C., Cotroneo, P., Manto, A., Minnella, A., Ward, J. D., Tesfaye, S., Eaton, S., Mody, C., Porta, M., Perin, P. Cavallo, Borra, M., Giunti, S., Papazoglou, N., Manes, Gianfranco, Muggeo, M., Iagulli, M., Irsigler, K., Abrahamian, H., Walford, S., Wardle, E. V., Sinclair, J., Hughes, S., Roglic, G., Metelko, Z., Resman, Z., Sjolie, A. -. K., Chaturvedi, N., Ferriss, B., Webb, D., Viberti, G. -. C., Swaminathan, R., Lumb, P., Collins, A., Sankaralingham, S., Aldington, S., Mortemore, T., and Lipinski, H.

Subjects
Albuminuria, Blood sugar control, Cardiovascular disease, Insulin resistance, Renal disease, Adolescent, Adult, Blood Glucose, Body Constitution, Cohort Studies, Diabetes Mellitus, Type 1, Differential Threshold, Disease Progression, Europe, Female, Follow-Up Studies, Humans, Incidence, Insulin Resistance, Male, Middle Aged, Prospective Studies, Reference Values, Risk Factors, Triglycerides, Nephrology, endocrine system diseases, urologic and male genital diseases, Gastroenterology, Waist–hip ratio, Proteinuria, Settore MED/30 - MALATTIE APPARATO VISIVO, female genital diseases and pregnancy complications, medicine.symptom, Type 1, medicine.medical_specialty, Internal medicine, Diabetes mellitus, Diabetes Mellitus, medicine, Risk factor, Glycemic, Type 1 diabetes, business.industry, nutritional and metabolic diseases, medicine.disease, Endocrinology, Microalbuminuria, business
Abstract

Microalbuminuria in type 1 diabetes: Rates, risk factors and glycemic threshold.BackgroundThe occurrence of microalbuminuria in type 1 diabetes is strongly predictive of renal and cardiovascular disease and is still likely to occur despite improvements in glycemic control. A better understanding of microalbuminuria is required to inform new interventions. We determined the incidence and risk factors for microalbuminuria [albumin excretion rate (AER) 20 to 200 μg/min] in the EURODIAB Prospective Complications Study.MethodsThis is a seven-year follow-up (between 1988 and 1991) of 1134 normoalbuminuric men and women (aged 15 to 60) with type 1 diabetes from 31 European centers. Risk factors and AER were measured centrally.ResultsThe incidence of microalbuminuria was 12.6% over 7.3 years. Independent baseline risk factors were HbA1c (7.1 vs. 6.2%, P = 0.0001) and AER (9.6 vs. 7.8 μg/min, P = 0.0001) and, independent of these, fasting triglyceride (0.99 vs. 0.88 mmol/L, P = 0.01), low-density lipoprotein cholesterol (3.5 vs. 3.2 mmol/L, P = 0.02), body mass index (24.0 vs. 23.4 kg/m2, P = 0.01), and waist to hip ratio (WHR; 0.85 vs. 0.83, P = 0.009). Triglyceride and WHR risk factors were nearly as strong as AER in predicting microalbuminuria (standardized regression effects of 1.3 for triglyceride and WHR and 1.5 for AER). Blood pressure at follow-up, but not at baseline, was also raised in those who progressed. There was no evidence of a threshold of HbA1c on microalbuminuria risk.ConclusionsThe incidence of microalbuminuria in patients with type 1 diabetes remains high, and there is no apparent glycemic threshold for it. Markers of insulin resistance, such as triglyceride and WHR, are strong risk factors. Systemic blood pressure is not raised prior to the onset of microalbuminuria.

Published
2001

40. Continuosus subcutaneos glucose minitoring in diabetic patients: a multicenter analysis

Author

Maran A, Crepaldi C, Tiengo A, Grassi G, Vitali E, Pagano G, Bistoni S, Calabrese G, Santeusanio F, Leonetti F, Ribaudo M, Di Mario U, Previti M, Cucinotta D, Giorgino F, Bellomo A, Giorgino R, Poscia A, Varalli M., ANNUZZI, GIOVANNI, GENOVESE, SALVATORE, RICCARDI, GABRIELE, Maran, A, Crepaldi, C, Tiengo, A, Grassi, G, Vitali, E, Pagano, G, Bistoni, S, Calabrese, G, Santeusanio, F, Leonetti, F, Ribaudo, M, Di Mario, U, Annuzzi, Giovanni, Genovese, Salvatore, Riccardi, Gabriele, Previti, M, Cucinotta, D, Giorgino, F, Bellomo, A, Giorgino, R, Poscia, A, and Varalli, M.

Published
2002

43. Fibrinogen and von Willebrand factor in IDDM: relationships to lipid vascular risk factors, blood pressure, glycaemic control and urinary albumin excretion rate: the EURODIAB IDDM Complications Study

Author

Greaves, M, Malia, Rg, Goodfellow, K, Mattock, M, Stevens, Lk, Stephenson, Jm, Fuller, Jh, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Rottiers, R, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Djs, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Segato, T, Midena, E, Cipollina, Mr, Fedele, D, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Navelesi, R, Sjolie, Ak, Viberti, Gc, Ward, J, Partridge, T, John, Wg, Collins, A, Dredge, A, Sharp, R, Kohner, E, Aldington, S, Cockley, S., Greaves, M, Malia, Rg, Goodfellow, K, Mattock, M, Stevens, Lk, Stephenson, Jm, Fuller, Jh, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Giorgino, R, Cignarelli, M, Decicco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, D, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, Jb, Cronin, Cc, Whyte, Ae, Cleary, Pe, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Rottiers, R, Priem, H, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, Hmj, Lemkes, Hhpj, Jansen, Jj, Brachter, J, Nunescorrea, J, Boavida, J, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Dj, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Crepaldi, G, Nosadini, R, Segato, T, Midena, E, Cipollina, Mr, Fedele, D, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Perin, Pc, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Skazagar, G, Kontogiannis, I, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Hughes, S, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Navelesi, R, Sjolie, Ak, Viberti, Gc, Ward, J, Partridge, T, John, Wg, Collins, A, Dredge, A, Sharp, R, Kohner, E, Aldington, S, and Cockley, S.

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, Endocrinology, Diabetes and Metabolism, Blood lipids, Blood Pressure, Fibrinogen, Body Mass Index, Risk Factors, biology, Smoking, von Willebrand factor, fibrinogen, The EURODIAB IDDM Study, Europe, Cholesterol, Cardiovascular Diseases, Female, medicine.symptom, medicine.drug, Type 1, Adult, medicine.medical_specialty, HDL, LDL, Von Willebrand factor, Internal medicine, Diabetes mellitus, von Willebrand Factor, Internal Medicine, medicine, Diabetes Mellitus, Humans, Albuminuria, Cholesterol, HDL, Cholesterol, LDL, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetic Angiopathies, Triglycerides, Glycated Hemoglobin, business.industry, Vascular disease, medicine.disease, Blood pressure, Endocrinology, biology.protein, Microalbuminuria, business
Abstract

The interrelationships between fibrinogen, von Willebrand factor, a marker of vascular endothelial cell damage, and serum lipids were explored in well-characterised subjects with insulin-dependent diabetes mellitus. The 2091 subjects were enrolled into a cross-sectional, clinic-based study of complications, from 16 European countries: the EURODIAB IDDM Complications study. The anticipated significant relationships between both plasma fibrinogen and plasma von Willebrand factor concentrations and age and glycaemic control, and between fibrinogen and body mass index, were noted. Fibrinogen, adjusted for age and glycated haemoglobin concentration, was also related to smoking habits and was higher in the quartiles with highest systolic and diastolic blood pressures. There was a clustering of vascular risk factors, with a positive relationship between plasma fibrinogen and serum triglyceride concentrations in both genders and between fibrinogen and total cholesterol in males. An inverse relationship between fibrinogen and high density lipoprotein cholesterol was also apparent in males. A prominent feature was a positive relationship between both fibrinogen and von Willebrand factor and albumin excretion rate (p < 0.001 and p < 0.003 respectively) in those with retinopathy but not in these without this complication. In view of previous observations on blood pressure and albuminuria in these subjects the findings are consistent with the hypothesis that microalbuminuria and increased plasma von Willebrand factor are due to endothelial cell perturbation in response to mildly raised blood pressure in subjects with retinopathy. Fibrinogen may also contribute to microvascular disease and its relationships to lipid vascular risk factors suggest a possible pathogenic role in arterial disease in diabetes.

Published
1997

46. Nutritional intake of 2868 IDDM patients from 30 centres in Europe

Author

Toeller, M, Klischan, A, Heitkamp, G, Schumacher, W, Milne, R, Buyken, A, Karamanos, B, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Janse, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Alfonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Djs, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, F, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, Roberto, Nannipieri, Monica, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z., Toeller, M, Klischan, A, Heitkamp, G, Schumacher, W, Milne, R, Buyken, A, Karamanos, B, Gries, Fa, Fuller, Jh, Keen, H, Krans, Hmj, Navalesi, R, Sjolie, Ak, Stephenson, Jm, Viberti, Gc, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Roussipenessi, D, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Strachinariu, R, Nicolau, A, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferriss, B, Cronin, Cc, Humphreys, M, Forst, T, Wagener, W, Venhaus, A, Rottiers, R, Priem, H, Deschoolmeester, Mj, Ebeling, P, Sinisalo, M, Koivisto, Va, Idziorwalus, B, Solnica, B, Szopinskaciba, L, Solnica, K, Lemkes, Hhpj, Janse, Jj, Eltedewever, Bm, Nunescorrea, J, Boavida, J, Carvalho, R, Alfonso, Mj, Monteiro, M, David, R, Jepson, E, Mchardyyoung, S, Betteridge, Dj, Milne, M, Michel, G, Wirion, R, Paquet, S, Hornick, H, Boulton, Ajm, Ashe, H, Fernando, Dj, Curwell, J, Pozza, G, Slaviero, G, Comi, G, Fattor, B, Bandello, Francesco, Marchi, M, Mehnert, H, Nuber, A, Janka, H, Nichting, M, Crepaldi, G, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Baclet, N, Santeusanio, F, Rosi, G, Ventura, Mrm, Cagini, C, Marino, C, Penno, G, Miccoli, R, Nannipieri, M, Manfredi, S, Bertolotto, A, Ghirlanda, G, Cotroneo, P, Manto, A, Teodonio, C, Minnella, A, Careddu, G, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Goutzourela, M, Manes, C, Bensoussan, D, Fallas, Mc, Fallas, P, Dhanaeus, C, Bourgeois, Md, Muggeo, M, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Branzi, P, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Strohner, H, Just, M, Walford, S, Wardle, Ev, Henio, S, Cooke, H, Roglic, G, Resman, Z, Metelko, Z, and Skrabalo, Z.

Subjects
medicine.medical_specialty, education.field_of_study, Cross-sectional study, business.industry, Endocrinology, Diabetes and Metabolism, Saturated fat, Population, Nutritional intake, IDDM patients, medicine.disease, Diet Records, Endocrinology, Internal medicine, Diabetes mellitus, Cohort, Internal Medicine, medicine, Population study, education, business, Cohort study
Abstract

The EURODIAB IDDM Complications Study, a cross-sectional, clinic-based study, was designed to measure the prevalence of diabetic complications in stratified samples of European insulin-dependent diabetic (IDDM) patients. As diet may be related to diabetic complications, nutritional intake was analysed in the study population. The aims of this first nutritional paper are to describe the nutrient intake in 2868 IDDM patients from 30 centres in 16 countries throughout Europe, to investigate the degree of regional differences in nutrient intake and to compare current intakes with recommended levels. Nutritional intake from 1458 male and 1410 female IDDM patients was assessed by a validated 3-day record (two weekdays, Sunday) and centrally analysed. Mean energy intake for all patients was 2390 +/- 707 kcal/day. Mean protein intake was 1.5 +/- 0.5 g/kg body weight. Carbohydrate intake was 43% and fibre intake 18 g/day. Alcohol intake for the total cohort was 2% of energy. Total fat contributed 38% of energy, with 14% from saturated fat. The Italian centres reported lower total and saturated fat intakes compared with other centres. Recommendations from the Diabetes and Nutrition Study Group of the EASD for total fat, saturated fatty acids and carbohydrate were only achieved by 14%, 14% and 15% of patients, respectively. The data of the present study clearly indicate current problems in the nutritional intake of European IDDM patients. These findings contribute to the definition of future targets in the nutritional management of IDDM patients, to be achieved as part of the initiatives taken by the St. Vincent Declaration action programme.

Published
1996

47. Cardiovascular disease and its risk factors in IDDM in Europe

Author

Koivisto VA, Stevens LK, Mattock M, Ebeling P, Muggeo M, Stephenson J, IdziorWalus B, Karamanos B, Tountas C, Kofinis A, Petrou K, Katsilambros N, Cignarelli M, Giorgino R, DeGeco ML, Ramunni I, IonescuTirgoviste C, Iosif CM, Pitei C, Buligescu S, Tamas G, Kerenyi Z, Ahmed AM, Toth J, Kempler P, Muntoni S, Songini M, Stabilini M, Fossarello M, Pintus S, Ferris B, Cronin CC, Toeller M, Klischan A, Forst T, Gries FA, Wagener W, Rottiers R, Priem H, Sinisalo M, Solnica B, SzopinskaCiba L, Solnica K, Krans M, Lemkes HHPJ, Jansen JJ, NunesCorrea J, Rogado C, Boavida JM, Correia LG, Michel G, Wirion R, Boulton AJM, Ashe H, Fernando DJS, Pozza G, Slaviero G, Comi B, Fattor F, Janka HU, Nuber A, Mehnert H, BenSoussan D, Fallas MC, Fallas P, Jepson E, McHardyYoung S, Fuller JH, Betteridge DJ, Milne M, Crepaldi C, Nosadini R, Cathelineau G, Cathelineau BV, Jellal M, Grodner N, Feiss PG, Santeusanio F, Rosi G, Cagini C, Marino C, Navalesi R, Penno G, Miccoli R, Nannipieri M, Stefano M, Ghirlanda G, Controneo P, Manto A, Teodonio C, Minnella A, Ward JD, Tesfaye S, Mody C, Rudd C, Molinatti GM, Vitelli F, Porta M, Pagano GF, Estivi P, Sivieri R, Carta Q, Petraroli G, Papazoglou N, Manes G, Triantaphyllou G, Ioannides A, Cacciatori V, Bellavere F, Galante P, Gemma ML, Irsigler K, Abrahamian H, Gurdet C, Hornlein B, Willinger C, Walford S, Wardle EV, Roglic G, Resman Z, Metelko Z, Skrabalo Z, Keen H, Sjolie AK, Viberti GC, Ward J, John G, Collins A, Sharp R., BANDELLO , FRANCESCO, Koivisto, Va, Stevens, Lk, Mattock, M, Ebeling, P, Muggeo, M, Stephenson, J, Idziorwalus, B, Karamanos, B, Tountas, C, Kofinis, A, Petrou, K, Katsilambros, N, Cignarelli, M, Giorgino, R, Degeco, Ml, Ramunni, I, Ionescutirgoviste, C, Iosif, Cm, Pitei, C, Buligescu, S, Tamas, G, Kerenyi, Z, Ahmed, Am, Toth, J, Kempler, P, Muntoni, S, Songini, M, Stabilini, M, Fossarello, M, Pintus, S, Ferris, B, Cronin, Cc, Toeller, M, Klischan, A, Forst, T, Gries, Fa, Wagener, W, Rottiers, R, Priem, H, Sinisalo, M, Solnica, B, Szopinskaciba, L, Solnica, K, Krans, M, Lemkes, Hhpj, Jansen, Jj, Nunescorrea, J, Rogado, C, Boavida, Jm, Correia, Lg, Michel, G, Wirion, R, Boulton, Ajm, Ashe, H, Fernando, Dj, Pozza, G, Slaviero, G, Comi, B, Fattor, F, Bandello, Francesco, Janka, Hu, Nuber, A, Mehnert, H, Bensoussan, D, Fallas, Mc, Fallas, P, Jepson, E, Mchardyyoung, S, Fuller, Jh, Betteridge, Dj, Milne, M, Crepaldi, C, Nosadini, R, Cathelineau, G, Cathelineau, Bv, Jellal, M, Grodner, N, Feiss, Pg, Santeusanio, F, Rosi, G, Cagini, C, Marino, C, Navalesi, R, Penno, G, Miccoli, R, Nannipieri, M, Stefano, M, Ghirlanda, G, Controneo, P, Manto, A, Teodonio, C, Minnella, A, Ward, Jd, Tesfaye, S, Mody, C, Rudd, C, Molinatti, Gm, Vitelli, F, Porta, M, Pagano, Gf, Estivi, P, Sivieri, R, Carta, Q, Petraroli, G, Papazoglou, N, Manes, G, Triantaphyllou, G, Ioannides, A, Cacciatori, V, Bellavere, F, Galante, P, Gemma, Ml, Irsigler, K, Abrahamian, H, Gurdet, C, Hornlein, B, Willinger, C, Walford, S, Wardle, Ev, Roglic, G, Resman, Z, Metelko, Z, Skrabalo, Z, Keen, H, Sjolie, Ak, Viberti, Gc, Ward, J, John, G, Collins, A, and Sharp, R.

Subjects
medicine.medical_specialty, Cross-sectional study, Endocrinology, Diabetes and Metabolism, Population, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Cardiovascular disease, EURODIAB IDDM study, 03 medical and health sciences, 0302 clinical medicine, Insulin resistance, Internal medicine, Diabetes mellitus, Internal Medicine, Medicine, Risk factor, education, Advanced and Specialized Nursing, education.field_of_study, business.industry, medicine.disease, 3. Good health, Endocrinology, Blood pressure, Albuminuria, Metabolic syndrome, medicine.symptom, business
Abstract

OBJECTIVE To study the prevalence of cardiovascular disease (CVD), its risk factors, and their associations in IDDM patients in different European countries. RESEARCH DESIGN AND METHODS The prevalence of CVD (a past history or electrocardiogram abnormalities) and its risk factors were examined in a cross-sectional study in 3,250 IDDM patients from 16 European countries (EURODIAB IDDM Complications Study). The patients were examined in 31 centers and were stratified between centers for age, sex, and duration of diabetes. The mean ± SD duration of diabetes was 14.7 ± 9.3 years. RESULTS The prevalence of CVD was 9% in men and 10% in women. The prevalence increased with age (from 6% in patients 15–29 years old to 25% in patients 45–59 years old) and with duration of diabetes. The between-center variation for the whole population was from 3 to 19%. In both sexes, fasting triglyceride concentration was higher and HDL cholesterol lower in those patients with CVD than in those without. In men, duration of diabetes was longer, waist-to-hip ratio greater, and hypertension more common in patients with CVD. In women, a greater BMI was associated with increased prevalence of CVD. There was no association between insulin dose, HbA1c level, age-adjusted rate of albumin excretion, or smoking status and CVD. Waist-to-hip ratio, particularly in men, was positively associated with age, age-adjusted HbA1c, prevalence of smoking, daily insulin dose, albumin excretion rate, and fasting triglyceride concentrations. CONCLUSIONS The overall prevalence of CVD in these IDDM patients was ∼ 10%, increasing with age and duration of diabetes and with a sixfold variation between different European centers. CVD prevalence was most strongly associated with elevated triglyceride and decreased HDL cholesterol concentrations. CVD was also associated with albuminuria, but when adjusted by age, this association vanished. Increasing waist-to-hip ratio was associated with a number of adverse characteristics, particularly in IDDM men, reflecting the metabolic syndrome previously described in other populations.

Published
1996

48. Prevenzione del diabete di tipo 2

Author

Corigliano, G., Coscelli, C., DE FEO, Pierpaolo, Giorgino, R., Giorda, C, Rivellese, A, Rotella, C, and Vaccaro, O.

Published
2006

49. Validation of the Italian version of the WHO-Well-Being Questionnaire (WHO-WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ)

Author

Nicolucci, A., Giorgino, R., Domenico Maria CUCINOTTA, Zoppini, G., Muggeo, M., Squatrito, S., Corsi, A., Lostia, S., Pappalardo, L., Benaduce, E., Girelli, A., Galeone, F., Maldonato, A., Perriello, G., Pata, P., Marra, G., and Coronel, G. A.

Subjects
Adult, Male, Self-Assessment, Time Factors, quality of life, satisfaction, questionnaire, diabetes, Psychometrics, Health Status, Reproducibility of Results, Middle Aged, World Health Organization, Diabetes Complications, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Italy, Surveys and Questionnaires, Quality of Life, Humans, Female, Aged
Abstract

To validate the Italian version of the World Health Organization (WHO)-Well-Being Questionnaire (WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (DTSQ) in Type 1 and Type 2 diabetic patients.The cultural adaptation of the questionnaires was performed by using standard forward/backward techniques. Internal consistency reliability was estimated by Cronbach's alpha coefficient. Construct validity was evaluated using the Short Form-36 (SF-36) Health Status Questionnaire. Finally, the discriminative properties of the questionnaires were evaluated relative to the patients' characteristics. The questionnaires were administered to a random sample of patients identified in twelve outpatient diabetes clinics.Overall, 412 subjects were recruited, of whom 96 (23%) with Type 1 diabetes. Item-scale correlations were0.40 for all the items. Cronbach's alpha coefficient was 0.86 for the WHO-DTSQ and ranged between 0.79 and 0.91 for the WHO-WBQ. High correlations were found between WHO-WBQ scales and the mental dimensions of the Short Form-36 (SF-36) questionnaire, but not between WHO-DTSQ and SF-36 scores. Women, obese subjects, those with longer diabetes duration and multiple complications showed a worse quality of life in all of the four areas of the WHO-WBQ. In Type 2 diabetic subjects, SF-36 scores, but not WHO-WBQ scores, were able to discriminate the population according to the treatment modalities. Lower levels of treatment satisfaction were related to female gender, longer diabetes duration, insulin treatment, presence of diabetes complications and HbA1c levels7.0%. The flexibility of the treatement was perceived as a major problem even among patients treated with oral agents.The WHO-DTSQ can be considered as a valuable instrument to be used internationally for the description of diabetes treatment satisfaction. The WHO-WBQ also shows adequate psychometric properties, but additional data are needed to clarify whether it is more sensitive than SF-36, the most widely used generic instrument.

Published
2004

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