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Epidemiology of Diabetes Interventions and Complications (EDIC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360893
First Posted: August 7, 2006
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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: Observational Model: Cohort
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):

Enrollment: 1441
Study Start Date: April 1994
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in the DCCT
Criteria

Inclusion Criteria:

  • A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360893


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92093
United States, Maryland
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
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Case Western Reserve University, Clinical Coordinating Center
Cleveland, Ohio, United States, 44106
Canada, Ontario
University of Toronto, Mount Sinai Hospital
Toronto, Ontario, Canada, M5t 3L9
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Chair: David M Nathan, M.D. Massachusetts General Hospital
Principal Investigator: Rose A Gugitosi-Klug, M.D., Ph.D. Case Western Reserve University
Principal Investigator: John M. Lachin, Sc.D. George Washington University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00360893     History of Changes
Other Study ID Numbers: N01-DK-6-2204
U01DK094176 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2006
First Posted: August 7, 2006
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIDDK Repository

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