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Trial record 1 of 1 for:    NCT00360893
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Epidemiology of Diabetes Interventions and Complications (EDIC)

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ClinicalTrials.gov Identifier: NCT00360893
Recruitment Status : Active, not recruiting
First Posted : August 7, 2006
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Type 1 Diabetes Mellitus

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Study Design

Study Type : Observational
Actual Enrollment : 1441 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Diabetes Interventions and Complications (EDIC)
Study Start Date : April 1994
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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)
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 Posted: August 7, 2006    Key Record Dates
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