Epidemiology of Diabetes Interventions and Complications (EDIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00360893
First received: August 3, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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
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  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

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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):

ClinicalTrials.gov Identifier: NCT00360893     History of Changes
Other Study ID Numbers: N01-DK-6-2204
Study First Received: August 3, 2006
Last Updated: October 31, 2013
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 April 22, 2014