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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360893

  Hide Study Locations
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
University of Maryland
Baltimore, Maryland, United States, 21201
George Washington University, Biostatistics Center, Data Coordinating Center
Bethesda, Maryland, United States, 20852
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
United States, Massachusetts
EDIC Carotid Ultrasound Reading Unit
Boston, Massachusetts, United States, 02116
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48292
United States, Minnesota
EDIC Central Biochemistry Laboratory
Minneapolis, Minnesota, United States, 55455
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
University of Minnesota
Minneapolis, Minnesota, United States, 55455
EDIC Central ECG Reading Unit
Minneapolis, Minnesota, United States, 55454
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
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Cornell University Medical Center
New York, New York, United States, 10021
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 Western Ontario
London Ontario, Ontario, Canada, N6A 5A5
University of Toronto, Mount Sinai Hospital
Toronto, Ontario, Canada, M5t 3L9
EDIC Genetic Studies Unit
Toronto, Ontario, Canada, M5G 1L7
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 September 30, 2014