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Epidemiology of Diabetes Interventions and Complications (EDIC)
This study has been completed.
First Received: August 3, 2006   Last Updated: August 4, 2006   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: Natural History, Longitudinal, Defined Population, Prospective Study
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 National Clinical Trials Identifier (NCT ID):
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.

Study ID Numbers: N01-DK-6-2204
Study First Received: August 3, 2006
Last Updated: August 4, 2006
ClinicalTrials.gov Identifier: NCT00360893     History of Changes
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on February 08, 2010