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Epidemiology of Diabetes Interventions and Complications (EDIC)
This study has been completed.

First Received on August 3, 2006.   Last Updated on March 1, 2010   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00360893
  Purpose

OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications.

Contemporary prospective data on the evolution of macrovascular and late micro vascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its 13th year of followup. The study is expecting to last until 2016.

RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be perf o rmed at years 1 and 6 and at study end.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiology of Diabetes Interventions and Complications (EDIC)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: April 1994
Estimated Study Completion Date: February 2016
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360893

  Show 40 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Saul M. Genuth, M.D. Case Western Reserve University
Study Chair: David M. Nathan, M.D. Massachusetts General Hospital
Study Director: Catherine Cowie, Ph.D. National Institutes of Health, Naitonal Institute of Diabetes and Digestive and Kidney Diseases
Principal Investigator: William Dahms, M.D. Case Western Reserve University
Principal Investigator: Patricia A Cleary, M.S. George Washington University
Principal Investigator: John M. Lachin, Sc.D. George Washington University
Principal Investigator: Bernard Zinman, M.D., F.A.C.P. University of Toronto, Mount Sinai Hospital
Principal Investigator: Mark Palmert, Ph.D. Case Western Reserve University
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. 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. 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. Epub 2010 Dec 16.
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. Epub 2010 Oct 28.
Martin CL, Waberski BH, Pop-Busui R, Cleary PA, Catton S, Albers JW, Feldman EL, Herman WH; DCCT/EDIC Research Group. Vibration perception threshold as a measure of distal symmetrical peripheral neuropathy in type 1 diabetes: results from the DCCT/EDIC study. Diabetes Care. 2010 Dec;33(12):2635-41. Epub 2010 Sep 10.
Jacobson AM, Ryan CM, Cleary PA, Waberski BH, Weinger K, Musen G, Dahms W; Diabetes Control and Complications Trial/EDIC Research Group. Biomedical risk factors for decreased cognitive functioning in type 1 diabetes: an 18 year follow-up of the Diabetes Control and Complications Trial (DCCT) cohort. Diabetologia. 2011 Feb;54(2):245-55. Epub 2010 Aug 29.
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.
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. Epub 2010 May 6.
Albers JW, Herman WH, Pop-Busui R, Feldman EL, Martin CL, Cleary PA, Waberski BH, Lachin JM; Diabetes Control and Complications Trial /Epidemiology of Diabetes Interventions and Complications Research Group. Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Complications (EDIC) Study. Diabetes Care. 2010 May;33(5):1090-6. Epub 2010 Feb 11.
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. Epub 2010 Feb 11.
Jacobson AM, Paterson AD, Ryan CM, Cleary PA, Waberski BH, Weinger K, Musen G, Dahms W, Bayless M, Silvers N, Harth J, Boright AP; DCCT/EDIC Research Group. The associations of apolipoprotein E and angiotensin-converting enzyme polymorphisms and cognitive function in Type 1 diabetes based on an 18-year follow-up of the DCCT cohort. Diabet Med. 2010 Jan;27(1):15-22.
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.
Musen G, Jacobson AM, Ryan CM, Cleary PA, Waberski BH, Weinger K, Dahms W, Bayless M, Silvers N, Harth J, White N; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Glycemic control and hypoglycemia: is the loser the winner? Response to Perlmuter et al. Diabetes Care. 2009 Apr;32(4):e46; discussion e47. No abstract available.
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.
Musen G, Jacobson AM, Ryan CM, Cleary PA, Waberski BH, Weinger K, Dahms W, Bayless M, Silvers N, Harth J, White N; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Impact of diabetes and its treatment on cognitive function among adolescents who participated in the Diabetes Control and Complications Trial. Diabetes Care. 2008 Oct;31(10):1933-8. Epub 2008 Jul 7.
Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group; Jacobson AM, Musen G, Ryan CM, Silvers N, Cleary P, Waberski B, Burwood A, Weinger K, Bayless M, Dahms W, Harth J. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med. 2007 May 3;356(18):1842-52.

ClinicalTrials.gov Identifier: NCT00360893     History of Changes
Other Study ID Numbers: N01-DK-6-2204 (completed)
Study First Received: August 3, 2006
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012