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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 9, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
George Washington University

Tracking Information
First Submitted Date August 3, 2006
First Posted Date August 7, 2006
Last Update Posted Date February 9, 2023
Study Start Date April 1994
Estimated Primary Completion Date June 2027   (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

The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c <7% was adopted world-wide as standard-of-care for T1DM.

The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for ~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality.

The overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age.
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 Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).
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 2027
Estimated Primary Completion Date June 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria Participants originally enrolled 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 Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number NCT00360893
Other Study ID Numbers N01-DK-6-2204
U01DK094176 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: NIDDK Central Repository
Current Responsible Party George Washington University
Original Responsible Party Not Provided
Current Study Sponsor George Washington University
Original Study Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: Barbara H Braffett, Ph.D. George Washington University
Principal Investigator: Ionut Bebu, Ph.D. George Washington University
PRS Account George Washington University
Verification Date January 2023