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Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 3, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study description expanded, about 8 wordsv7
  2. Minor Study description expanded, about 315 wordsv6
  3. Notable Primary completion date: Dec 2024 to Dec 2025
    • Site details revised
    • Study description expanded, about 2 words
    v5
  4. Minor Study description expanded, about 11 wordsv4
  5. Notable Primary completion date: Feb 2024 to Dec 2024
    • Study completion date: Aug 2024 to Dec 2025
    • Collaborators expanded, about 4 words
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 10, 2022 to May 3, 2022
    • Study sites: 0 to 1
    v2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D). Background: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed. Methods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected. Blood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades. Perspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.
Trial Details
NCT Number NCT05159856
Lead Sponsor Steno Diabetes Center Copenhagen
Collaborators: Steno Diabetes Center Sjaelland
Conditions
(from sponsor)
Diabetes Complications, type1diabetes, Children, Only, Diabetic Neuropathies, Arterial Stiffness
Related terms Diabetes Complications, Diabetes Mellitus, Type 1, Diabetic Neuropathies
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov