Ophthalmology 2006 Sep;113(9):1488-98.
Section 4B - Study Objectives/Background and Significance (Phase 3 - 12/2010)
Section 4B - Page 17
Cohort
Study
46.
U.S.Renal Data System. USRDS 2009 Annual Data Report: Atlas of End-Stage Renal
Disease in the United States. Bethesda, MD: National Institutes of Health, Natinal Institute
of Diabetes and Digestive and Kidney Diseases; 2009.
47.
Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the
risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004 Sep
23;351(13):1296-305.
48.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional
treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK
Prospective Diabetes Study (UKPDS) Group. Lancet 1998 Sep 12;352(9131):837-53.
49.
Anderson EJ, Richardson M, Castle G, Cercone S, Delahanty L, Lyon R, Mueller D,
Snetselaar L. Nutrition interventions for intensive therapy in the Diabetes Control and
Complications Trial. The DCCT Research Group. J Am Diet Assoc 1993 Jul;93(7):768-72.
50.
Chavers BM, Mauer SM, Ramsay RC, Steffes MW. Relationship between retinal and
glomerular lesions in IDDM patients. Diabetes 1994 Mar;43(3):441-6.
51.
Bakris GL, Weir MR, Shanifar S, Zhang Z, Douglas J, van Dijk DJ, Brenner BM. Effects
of blood pressure level on progression of diabetic nephropathy: results from the RENAAL
study. Arch Intern Med 2003 Jul 14;163(13):1555-65.
52.
Lurbe E, Redon J, Kesani A, Pascual JM, Tacons J, Alvarez V, Batlle D. Increase in
nocturnal blood pressure and progression to microalbuminuria in type 1 diabetes. N Engl J
Med 2002 Sep 12;347(11):797-805.
53.
Fried LF, Forrest KY, Ellis D, Chang Y, Silvers N, Orchard TJ. Lipid modulation in
insulin-dependent diabetes mellitus: effect on microvascular outcomes. J Diabetes
Complications 2001 May;15(3):113-9.
54.
Jenkins AJ, Lyons TJ, Zheng D, Otvos JD, Lackland DT, McGee D, Garvey WT, Klein
RL. Lipoproteins in the DCCT/EDIC cohort: associations with diabetic nephropathy.
Kidney Int 2003 Sep;64(3):817-28.
55.
Astrup AS, Tarnow L, Pietraszek L, Schalkwijk CG, Stehouwer CD, Parving HH, Rossing
P. Markers of endothelial dysfunction and inflammation in type 1 diabetic patients with or
without diabetic nephropathy followed for 10 years: association with mortality and decline
of glomerular filtration rate. Diabetes Care 2008 Jun;31(6):1170-6.
56.
Jorsal A, Tarnow L, Frystyk J, Lajer M, Flyvbjerg A, Parving HH, Vionnet N, Rossing P.
Serum adiponectin predicts all-cause mortality and end stage renal disease in patients with
type I diabetes and diabetic nephropathy. Kidney Int 2008 Sep;74(5):649-54.
57.
Dalla VM, Mussap M, Gallina P, Bruseghin M, Cernigoi AM, Saller A, Plebani M, Fioretto
P. Acute-phase markers of inflammation and glomerular structure in patients with type 2
diabetes. J Am Soc Nephrol 2005 Mar;16 Suppl 1:S78-S82.
Section 4B - Study Objectives/Background and Significance (Phase 3 - 12/2010)
Section 4B - Page 18
Cohort
Study
58.
Melamed ML, Astor B, Michos ED, Hostetter TH, Powe NR, Muntner P. 25-
hydroxyvitamin D levels, race, and the progression of kidney disease. J Am Soc Nephrol
2009 Dec;20(12):2631-9.
59.
de B, I, Ioannou GN, Kestenbaum B, Brunzell JD, Weiss NS. 25-Hydroxyvitamin D levels
and albuminuria in the Third National Health and Nutrition Examination Survey
(NHANES III). Am J Kidney Dis 2007 Jul;50(1):69-77.
60.
Kostraba JN, Dorman JS, Orchard TJ, Becker DJ, Ohki Y, Ellis D, Doft BH, Lobes LA,
LaPorte RE, Drash AL. Contribution of diabetes duration before puberty to development of
microvascular complications in IDDM subjects. Diabetes Care 1989 Nov;12(10):686-93.
61.
Bognetti E, Calori G, Meschi F, Macellaro P, Bonfanti R, Chiumello G. Prevalence and
correlations of early microvascular complications in young type I diabetic patients: role of
puberty. J Pediatr Endocrinol Metab 1997 Nov;10(6):587-92.
62.
Lawson ML, Sochett EB, Chait PG, Balfe JW, Daneman D. Effect of puberty on markers
of glomerular hypertrophy and hypertension in IDDM. Diabetes 1996 Jan;45(1):51-5.
63.
Olsen BS, Sjolie AK, Hougaard P, Johannesen J, Marinelli K, Jacobsen BB, Mortensen
HB. The significance of the prepubertal diabetes duration for the development of
retinopathy and nephropathy in patients with type 1 diabetes. J Diabetes Complications
2004 May;18(3):160-4.
64.
Drummond KN, Kramer MS, Suissa S, Levy-Marchal C, Dell'Aniello S, Sinaiko A, Mauer
M. Effects of duration and age at onset of type 1 diabetes on preclinical manifestations of
nephropathy. Diabetes 2003 Jul;52(7):1818-24.
65.
Amin R, Turner C, van AS, Bahu TK, Watts A, Lindsell DR, Dalton RN, Dunger DB. The
relationship between microalbuminuria and glomerular filtration rate in young type 1
diabetic subjects: The Oxford Regional Prospective Study. Kidney Int 2005
Oct;68(4):1740-9.
66.
Ishimura E, Taniwaki H, Tsuchida T, Obatake N, Emoto M, Shoji T, Shioi A, Inaba M,
Nishizawa Y. Urinary albumin excretion associated with arterial wall stiffness rather than
thickness in type 2 diabetic patients. J Nephrol 2007 Mar;20(2):204-11.
67.
Yokoyama H, Aoki T, Imahori M, Kuramitsu M. Subclinical atherosclerosis is increased in
type 2 diabetic patients with microalbuminuria evaluated by intima-media thickness and
pulse wave velocity. Kidney Int 2004 Jul;66(1):448-54.
68.
Maahs DM, Snively BM, Bell RA, Dolan L, Hirsch I, Imperatore G, Linder B, Marcovina
SM, Mayer-Davis EJ, Pettitt DJ, Rodriguez BL, Dabelea D. Higher prevalence of elevated
albumin excretion in youth with type 2 than type 1 diabetes: the SEARCH for Diabetes in
Youth study. Diabetes Care 2007 Oct;30(10):2593-8.
Section 4B - Study Objectives/Background and Significance (Phase 3 - 12/2010)
Section 4B - Page 19
Cohort
Study
69.
Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE,
Sosenko JM, Ziegler D. Diabetic neuropathies: a statement by the American Diabetes
Association. Diabetes Care 2005 Apr;28(4):956-62.
70.
Edwards JL, Vincent AM, Cheng HT, Feldman EL. Diabetic neuropathy: mechanisms to
management. Pharmacol Ther 2008 Oct;120(1):1-34.
71.
Allen C, Shen G, Palta M, Lotz B, Jacobson R, D'Alessio D. Long-term hyperglycemia is
related to peripheral nerve changes at a diabetes duration of 4 years. The Wisconsin
Diabetes Registry. Diabetes Care 1997 Jul;20(7):1154-8.
72.
Pop-Busui R. Cardiac autonomic neuropathy in diabetes: a clinical perspective. Diabetes
Care 2010 Feb;33(2):434-41.
73.
Pop-Busui R, Low PA, Waberski BH, Martin CL, Albers JW, Feldman EL, Sommer C,
Cleary PA, Lachin JM, Herman WH. Effects of prior intensive insulin therapy on cardiac
autonomic nervous system function in type 1 diabetes mellitus: the Diabetes Control and
Complications Trial/Epidemiology of Diabetes Interventions and Complications study
(DCCT/EDIC). Circ 2009 Jun 9;119(22):2886-93.
74.
Adler GK, Bonyhay I, Failing H, Waring E, Dotson S, Freeman R. Antecedent
hypoglycemia impairs autonomic cardiovascular function: implications for rigorous
glycemic control. Diabetes 2009 Feb;58(2):360-6.
75.
Prince CT, Secrest AM, Mackey RH, Arena VC, Kingsley LA, Orchard TJ. Cardiovascular
autonomic neuropathy, HDL cholesterol, and smoking correlate with arterial stiffness
markers determined 18 years later in type 1 diabetes. Diabetes Care 2010 Mar;33(3):652-7.
76.
Ziegler D, Zentai CP, Perz S, Rathmann W, Haastert B, Doring A, Meisinger C. Prediction
of mortality using measures of cardiac autonomic dysfunction in the diabetic and
nondiabetic population: the MONICA/KORA Augsburg Cohort Study. Diabetes Care 2008
Mar;31(3):556-61.
77.
Ziegler D, Gries FA, Spuler M, Lessmann F. The epidemiology of diabetic neuropathy.
Diabetic Cardiovascular Autonomic Neuropathy Multicenter Study Group. J Diabetes
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