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Epidemiology of Diabetes Interventions and Complications (EDIC)

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.
 
ClinicalTrials.gov Identifier: NCT00360893
Recruitment Status : Active, not recruiting
First Posted : August 7, 2006
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 microvascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multi-center, longitudinal, observational study designed to utilize the well-characterized DCCT cohort of ~1,400 participants to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. The current phase of EDIC also focuses on the interaction between and the effects of aging and long-duration diabetes on cognitive and physical function as well as the long-term effects of diabetes-related complications on quality-of-life and health care costs. EDIC is in its 27th year of follow-up.

Methods: Data collection focuses on micro- and macrovascular complications. Annual or biennial measurements (using DCCT methods, standardized protocols and central laboratories) of vascular events, albumin excretion, GFR, ECG, ankle-brachial BP index, serum lipids and HbA1c allows the following analyses: 1) continuation of intention-to-treat analyses to determine long-term effects of prior separation of glycemic levels; 2) risk factors for macrovascular outcomes; 3) correlation of progression of micro- and macrovascular outcomes.


Condition or disease
Type 1 Diabetes Mellitus

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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






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
Criteria

Inclusion Criteria:

  • A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).

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
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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
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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
Publications of Results:

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

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00360893    
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: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIDDK Repository
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases