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Diabetes Control and Complications Trial (DCCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360815
First Posted: August 7, 2006
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
No Study Results Posted on ClinicalTrials.gov for this Study
  Study Status: This study has been completed.
  Estimated Study Completion Date: April 1993
  Primary Completion Date: No date given
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
DCCT/EDIC Research Group, Nathan DM, Bebu I, Hainsworth D, Klein R, Tamborlane W, Lorenzi G, Gubitosi-Klug R, Lachin JM. Frequency of Evidence-Based Screening for Retinopathy in Type 1 Diabetes. N Engl J Med. 2017 Apr 20;376(16):1507-1516. doi: 10.1056/NEJMoa1612836.
Lenherr SM, Clemens JQ, Braffett BH, Dunn RL, Cleary PA, Kim C, Herman WH, Hotaling JM, Jacobson AM, Brown JS, Wessells H, Sarma AV; DCCT/EDIC Research Group. Glycaemic control and risk of incident urinary incontinence in women with Type 1 diabetes: results from the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. Diabet Med. 2016 Nov;33(11):1528-1535. doi: 10.1111/dme.13126. Epub 2016 Apr 24.
Sell DR, Sun W, Gao X, Strauch C, Lachin JM, Cleary PA, Genuth S; DCCT/EDIC Research Group, Monnier VM. Skin collagen fluorophore LW-1 versus skin fluorescence as markers for the long-term progression of subclinical macrovascular disease in type 1 diabetes. Cardiovasc Diabetol. 2016 Feb 11;15:30. doi: 10.1186/s12933-016-0343-3.
Kim C, Bebu I, Braffett B, Cleary PA, Arends V, Steffes M, Wessells H, Orchard T, Sarma AV; DCCT/EDIC Research Group. Testosterone and cardiac mass and function in men with type 1 diabetes in the Epidemiology of Diabetes Interventions and Complications Study (EDIC). Clin Endocrinol (Oxf). 2016 May;84(5):693-9. doi: 10.1111/cen.12990. Epub 2016 Jan 25.
Writing Team for the DCCT/EDIC Research Group, Gubitosi-Klug RA, Sun W, Cleary PA, Braffett BH, Aiello LP, Das A, Tamborlane W, Klein R. Effects of Prior Intensive Insulin Therapy and Risk Factors on Patient-Reported Visual Function Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Cohort. JAMA Ophthalmol. 2016 Feb;134(2):137-45. doi: 10.1001/jamaophthalmol.2015.4606.
Kim C, Pop-Busui R, Braffett B, Cleary PA, Bebu I, Wessells H, Orchard T, Sarma AV; DCCT/E.D.I.C. Research Group. Testosterone Concentrations and Cardiovascular Autonomic Neuropathy in Men with Type 1 Diabetes in the Epidemiology of Diabetes Interventions and Complications Study (EDIC). J Sex Med. 2015 Nov;12(11):2153-9. doi: 10.1111/jsm.13029. Epub 2015 Nov 12.
Monnier VM, Sun W, Gao X, Sell DR, Cleary PA, Lachin JM, Genuth S; DCCT/EDIC Research Group. Skin collagen advanced glycation endproducts (AGEs) and the long-term progression of sub-clinical cardiovascular disease in type 1 diabetes. Cardiovasc Diabetol. 2015 Sep 5;14:118. doi: 10.1186/s12933-015-0266-4. Erratum in: Cardiovasc Diabetol. 2015;14:138.
Eny KM, Orchard TJ, Miller RG, Maynard J, Grant DM, Costacou T, Cleary PA, Braffett BH, Paterson AD; DCCT/EDIC Research Group. Caffeine Consumption Contributes to Skin Intrinsic Fluorescence in Type 1 Diabetes. Diabetes Technol Ther. 2015 Oct;17(10):726-34. doi: 10.1089/dia.2015.0017. Epub 2015 Jul 20.
Lipska KJ, Montori VM. ACP Journal Club. In type 1 diabetes, intensive insulin therapy for 6.5 y reduced mortality at 27 y compared with usual care. Ann Intern Med. 2015 May 19;162(10):JC12. doi: 10.7326/ACPJC-2015-162-10-012.
Bharucha AE, Batey-Schaefer B, Cleary PA, Murray JA, Cowie C, Lorenzi G, Driscoll M, Harth J, Larkin M, Christofi M, Bayless M, Wimmergren N, Herman W, Whitehouse F, Jones K, Kruger D, Martin C, Ziegler G, Zinsmeister AR, Nathan DM; Diabetes Control and Complications Trial–Epidemiology of Diabetes Interventions and Complications Research Group. Delayed Gastric Emptying Is Associated With Early and Long-term Hyperglycemia in Type 1 Diabetes Mellitus. Gastroenterology. 2015 Aug;149(2):330-9. doi: 10.1053/j.gastro.2015.05.007. Epub 2015 May 14.
DCCT/EDIC Research Group, Aiello LP, Sun W, Das A, Gangaputra S, Kiss S, Klein R, Cleary PA, Lachin JM, Nathan DM. Intensive diabetes therapy and ocular surgery in type 1 diabetes. N Engl J Med. 2015 Apr 30;372(18):1722-33. doi: 10.1056/NEJMoa1409463.
Pop-Busui R, Hotaling J, Braffett BH, Cleary PA, Dunn RL, Martin CL, Jacobson AM, Wessells H, Sarma AV; DCCT/EDIC Research Group. Cardiovascular autonomic neuropathy, erectile dysfunction and lower urinary tract symptoms in men with type 1 diabetes: findings from the DCCT/EDIC. J Urol. 2015 Jun;193(6):2045-51. doi: 10.1016/j.juro.2014.12.097. Epub 2015 Jan 10. Erratum in: J Urol. 2015 Sep;194(3):855.
Writing Group for the DCCT/EDIC Research Group, Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.
Sarma AV, Hotaling J, Dunn RL, Cleary PA, Braffett BH, Kim C, Martin C, Herman W, Gatcomb P, Jacobson AM, Holt SK, Wessells H; DCCT/EDIC Research Group. Poor glycemic control is associated with reduced prostate specific antigen concentrations in men with type 1 diabetes. J Urol. 2015 Mar;193(3):786-93. doi: 10.1016/j.juro.2014.08.115. Epub 2014 Sep 11.
Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group, Lachin JM, White NH, Hainsworth DP, Sun W, Cleary PA, Nathan DM. Effect of intensive diabetes therapy on the progression of diabetic retinopathy in patients with type 1 diabetes: 18 years of follow-up in the DCCT/EDIC. Diabetes. 2015 Feb;64(2):631-42. doi: 10.2337/db14-0930. Epub 2014 Sep 9.
DCCT/EDIC research group. Effect of intensive diabetes treatment on albuminuria in type 1 diabetes: long-term follow-up of the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications study. Lancet Diabetes Endocrinol. 2014 Oct;2(10):793-800. doi: 10.1016/S2213-8587(14)70155-X. Epub 2014 Jul 17.
Eny KM, Lutgers HL, Maynard J, Klein BE, Lee KE, Atzmon G, Monnier VM, van Vliet-Ostaptchouk JV, Graaff R, van der Harst P, Snieder H, van der Klauw MM, Sell DR, Hosseini SM, Cleary PA, Braffett BH, Orchard TJ, Lyons TJ, Howard K, Klein R, Crandall JP, Barzilai N, Milman S, Ben-Avraham D; LifeLines Cohort Study Group; DCCT/EDIC Research Group, Wolffenbuttel BH, Paterson AD. GWAS identifies an NAT2 acetylator status tag single nucleotide polymorphism to be a major locus for skin fluorescence. Diabetologia. 2014 Aug;57(8):1623-34. doi: 10.1007/s00125-014-3286-9. Epub 2014 Jun 17.
McGee P, Steffes M, Nowicki M, Bayless M, Gubitosi-Klug R, Cleary P, Lachin J, Palmer J; DCCT/EDIC Research Group. Insulin secretion measured by stimulated C-peptide in long-established Type 1 diabetes in the Diabetes Control and Complications Trial (DCCT)/ Epidemiology of Diabetes Interventions and Complications (EDIC) cohort: a pilot study. Diabet Med. 2014 Oct;31(10):1264-8. doi: 10.1111/dme.12504. Epub 2014 Jun 9.
Larkin ME, Barnie A, Braffett BH, Cleary PA, Diminick L, Harth J, Gatcomb P, Golden E, Lipps J, Lorenzi G, Mahony C, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Musculoskeletal complications in type 1 diabetes. Diabetes Care. 2014 Jul;37(7):1863-9. doi: 10.2337/dc13-2361. Epub 2014 Apr 10.
Buschur E, Sarma AV, Pietropaolo M, Dunn RL, Braffett BH, Cleary PA, Cowie C, Larkin ME, Wessells H, Nathan DM, Kim C; DCCT/EDIC Research Group. Self-reported autoimmune disease by sex in the diabetes control and complications trial/epidemiology of diabetes interventions and complications (DCCT/EDIC) study. Diabetes Care. 2014 Feb;37(2):e28-9. doi: 10.2337/dc13-1890.
de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Zinman B, Steffes MW; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Longitudinal changes in estimated and measured GFR in type 1 diabetes. J Am Soc Nephrol. 2014 Apr;25(4):810-8. doi: 10.1681/ASN.2013050557. Epub 2013 Dec 5.
Nathan DM, Bayless M, Cleary P, Genuth S, Gubitosi-Klug R, Lachin JM, Lorenzi G, Zinman B; DCCT/EDIC Research Group. Diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: advances and contributions. Diabetes. 2013 Dec;62(12):3976-86. doi: 10.2337/db13-1093.
Kim C, Cleary PA, Cowie CC, Braffett BH, Dunn RL, Larkin ME, Gatcomb PM, Wessells HB, Nathan DM, Sarma AV; DCCT/EDIC Research Group. Effect of glycemic treatment and microvascular complications on menopause in women with type 1 diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort. Diabetes Care. 2014;37(3):701-8. doi: 10.2337/dc13-1746. Epub 2013 Oct 29.
Orchard TJ, Sun W, Cleary PA, Genuth SM, Lachin JM, McGee P, Paterson AD, Raskin P, Anbinder Y, Levy AP; DCCT/EDIC Research Group. Haptoglobin genotype and the rate of renal function decline in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes. 2013 Sep;62(9):3218-23. doi: 10.2337/db13-0256. Epub 2013 Jun 12.
Genuth SM, Backlund JY, Bayless M, Bluemke DA, Cleary PA, Crandall J, Lachin JM, Lima JA, Miao C, Turkbey EB; DCCT/EDIC Research Group. Effects of prior intensive versus conventional therapy and history of glycemia on cardiac function in type 1 diabetes in the DCCT/EDIC. Diabetes. 2013 Oct;62(10):3561-9. doi: 10.2337/db12-0546. Epub 2013 Mar 21.
Turkbey EB, Redheuil A, Backlund JY, Small AC, Cleary PA, Lachin JM, Lima JA, Bluemke DA; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Aortic distensibility in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2380-7. doi: 10.2337/dc12-0393. Epub 2013 Mar 8.
Pop-Busui R, Cleary PA, Braffett BH, Martin CL, Herman WH, Low PA, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Association between cardiovascular autonomic neuropathy and left ventricular dysfunction: DCCT/EDIC study (Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications). J Am Coll Cardiol. 2013 Jan 29;61(4):447-54. doi: 10.1016/j.jacc.2012.10.028. Epub 2012 Dec 19.
Purnell JQ, Zinman B, Brunzell JD; DCCT/EDIC Research Group. The effect of excess weight gain with intensive diabetes mellitus treatment on cardiovascular disease risk factors and atherosclerosis in type 1 diabetes mellitus: results from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study (DCCT/EDIC) study. Circulation. 2013 Jan 15;127(2):180-7. doi: 10.1161/CIRCULATIONAHA.111.077487. Epub 2012 Dec 4.
Kramer JR, Bayless ML, Lorenzi GM, Ziegler GK, Larkin ME, Lackaye ME, Harth J, Diminick LJ, Anderson KL, Braffett BH, Cleary PA; DCCT/EDIC Study Group. Participant characteristics and study features associated with high retention rates in a longitudinal investigation of type 1 diabetes mellitus. Clin Trials. 2012 Dec;9(6):798-805. doi: 10.1177/1740774512458986. Epub 2012 Oct 1.
de Boer IH, Sachs MC, Cleary PA, Hoofnagle AN, Lachin JM, Molitch ME, Steffes MW, Sun W, Zinman B, Brunzell JD; Diabetes Control and Complication Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Circulating vitamin D metabolites and kidney disease in type 1 diabetes. J Clin Endocrinol Metab. 2012 Dec;97(12):4780-8. doi: 10.1210/jc.2012-2852. Epub 2012 Sep 18.
Larkin ME, Lorenzi GM, Bayless M, Cleary PA, Barnie A, Golden E, Hitt S, Genuth S. Evolution of the study coordinator role: the 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Clin Trials. 2012 Aug;9(4):418-25. doi: 10.1177/1740774512449532. Epub 2012 Jun 22.
DCCT/EDIC Research Group, de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Steffes MW, Zinman B. Intensive diabetes therapy and glomerular filtration rate in type 1 diabetes. N Engl J Med. 2011 Dec 22;365(25):2366-76. doi: 10.1056/NEJMoa1111732. Epub 2011 Nov 12.
Turkbey EB, Backlund JY, Genuth S, Jain A, Miao C, Cleary PA, Lachin JM, Nathan DM, van der Geest RJ, Soliman EZ, Liu CY, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Myocardial structure, function, and scar in patients with type 1 diabetes mellitus. Circulation. 2011 Oct 18;124(16):1737-46. doi: 10.1161/CIRCULATIONAHA.111.022327. Epub 2011 Sep 26.
Gai N, Turkbey EB, Nazarian S, van der Geest RJ, Liu CY, Lima JA, Bluemke DA. T1 mapping of the gadolinium-enhanced myocardium: adjustment for factors affecting interpatient comparison. Magn Reson Med. 2011 May;65(5):1407-15. doi: 10.1002/mrm.22716. Epub 2010 Dec 16.
Polak JF, Backlund JY, Cleary PA, Harrington AP, O'Leary DH, Lachin JM, Nathan DM; DCCT/EDIC Research Group. Progression of carotid artery intima-media thickness during 12 years in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. Diabetes. 2011 Feb;60(2):607-13. doi: 10.2337/db10-0296.
Nathan DM, Steffes MW, Sun W, Rynders GP, Lachin JM. Determining stability of stored samples retrospectively: the validation of glycated albumin. Clin Chem. 2011 Feb;57(2):286-90. doi: 10.1373/clinchem.2010.150250. Epub 2010 Oct 28.
Larkin ME, Backlund JY, Cleary P, Bayless M, Schaefer B, Canady J, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Disparity in management of diabetes and coronary heart disease risk factors by sex in DCCT/EDIC. Diabet Med. 2010 Apr;27(4):451-8. doi: 10.1111/j.1464-5491.2010.02972.x.
Younes N, Cleary PA, Steffes MW, de Boer IH, Molitch ME, Rutledge BN, Lachin JM, Dahms W; DCCT/EDIC Research Group. Comparison of urinary albumin-creatinine ratio and albumin excretion rate in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study. Clin J Am Soc Nephrol. 2010 Jul;5(7):1235-42. doi: 10.2215/CJN.07901109. Epub 2010 May 6.
Molitch ME, Steffes M, Sun W, Rutledge B, Cleary P, de Boer IH, Zinman B, Lachin J; Epidemiology of Diabetes Interventions and Complications Study Group. Development and progression of renal insufficiency with and without albuminuria in adults with type 1 diabetes in the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study. Diabetes Care. 2010 Jul;33(7):1536-43. doi: 10.2337/dc09-1098. Epub 2010 Apr 22.
White NH, Sun W, Cleary PA, Tamborlane WV, Danis RP, Hainsworth DP, Davis MD; DCCT-EDIC Research Group. Effect of prior intensive therapy in type 1 diabetes on 10-year progression of retinopathy in the DCCT/EDIC: comparison of adults and adolescents. Diabetes. 2010 May;59(5):1244-53. doi: 10.2337/db09-1216. Epub 2010 Feb 11.
Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group, Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193.
White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, Hubbard LD, Lachin JM, Nathan DM. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15. doi: 10.1001/archopht.126.12.1707.


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