|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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) |
| 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:
Contacts and Locations
Hide Study Locations| United States, California | |
| University of California - San Diego | |
| San Diego, California, United States, 92121 | |
| EDIC Computed Tomography Reading Center | |
| Torrence, California, United States, 90509 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| University of South Florida College of Medicine | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases | |
| Bethesda, Maryland, United States, 20892-5460 | |
| George Washington University, Biostatistics Center, Data Coordinating Center | |
| Rockville, Maryland, United States, 20852 | |
| George Washington University, Biostatistics Center, Data Coordinating Center | |
| Bethesda, Maryland, United States, 20852 | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| EDIC Carotid Ultrasound Reading Unit | |
| Boston, Massachusetts, United States, 02116 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48292 | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| EDIC Central ECG Reading Unit | |
| Minneapolis, Minnesota, United States, 55454 | |
| International Diabetes Center | |
| Minneapolis, Minnesota, United States, 55416 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| EDIC Central Biochemistry Laboratory | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Foundation | |
| Rochester, Minnesota, United States, 55905 | |
| Autonomic Reading Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Washington University at St. Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Mexico | |
| University of Mexico School of Medicine | |
| Albuquerque, New Mexico, United States, 87131-5271 | |
| United States, New York | |
| Cornell University Medical Center | |
| New York, New York, United States, 10021 | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| EDIC EKG Reading Center, at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27104 | |
| United States, Ohio | |
| Case Western Reserve University, Clinical Coordinating Center | |
| Cleveland, Ohio, United States, 44106-4951 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-4957 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 250624 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| University of Texas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98108 | |
| United States, Wisconsin | |
| EDIC Central Ophthalmologic Reading Unit | |
| Madison, Wisconsin, United States, 53711 | |
| Canada, Ontario | |
| University of Toronto, Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5t 3L9 | |
| University of Western Ontario | |
| London Ontario, Ontario, Canada, N6A 5A5 | |
| EDIC Genetic Studies Unit | |
| Toronto, Ontario, Canada, M5G 1L7 | |
| 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
| 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 |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |
