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Epidemiology of Diabetes Interventions and Complications (EDIC)

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv13
  2. Study Status, Outcome Measuresv12
  3. Re-verified, no change to tracked fieldsv11
  4. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to George Washington University Collaborators expanded, about 10 wordsv10 Show all 2 changesShow less
    • Collaborators expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Jun 2022 to Jun 2027 Study sites: 7 to 0 · Eligibility criteria revised · Publications: 100 to 104v9 Show all 4 changesShow less
    • Study sites: 7 to 0
    • Eligibility criteria revised
    • Publications: 100 to 104

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Study description shortened, about 657 words Publications: 98 to 100v7 Show all 2 changesShow less
    • Publications: 98 to 100

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jun 2017 to Jun 2022 Study sites: 40 to 7 · Completion date: Jun 2022v6 Show all 3 changesShow less
    • Study sites: 40 to 7
    • Completion date: Jun 2022
  4. Enrollment target: 1441v5
  5. Primary completion date: Jun 2017 Completion date: Feb 2016 to not statedv4 Show all 2 changesShow less
    • Completion date: Feb 2016 to not stated
  6. Trial status: Completed to Active, Not Recruitingv3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00360893
Lead Sponsor George Washington University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes Mellitus
Enrollment 1,441 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov