Epidemiology of Diabetes Interventions and Complications (EDIC)
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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) |
| 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 |
Inclusion Criteria:
- A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).
Contacts and Locations
Show 40 Study Locations| 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 (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 May 23, 2013