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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)

Tracking Information
First Submitted Date August 3, 2006
First Posted Date August 7, 2006
Last Update Posted Date February 11, 2020
Study Start Date April 1994
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology of Diabetes Interventions and Complications (EDIC)
Official Title Epidemiology of Diabetes Interventions and Complications (EDIC)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients enrolled in the DCCT
Condition Type 1 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 18, 2016)
1441
Original Enrollment Not Provided
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A participant in the Diabetes Control and Complications Trial (DCCT)(N01-DK-6-2204-A).
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00360893
Other Study ID Numbers N01-DK-6-2204
U01DK094176 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: NIDDK Repository
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators Not Provided
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
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date February 2020