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Understanding Beta Cell Disorders Through the Study of Rare Genotypes (ENDURE)

Study acronym: ENDURE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Aug 20, 2024 to Nov 11, 2025
    • Site contact updated
    v4
  2. Minor Site contact updatedv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 31, 2028 to Feb 28, 2029
    • Start date changed from estimate of Jul 1, 2024 to Aug 20, 2024
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This observational 'recruit by genotype' study aims to provide insights into the cellular and molecular pathways underlying beta cell disorders and their physiological consequences. Eligible individuals are those with and without a pathogenic genetic variant, acting as case and control, respectively. Using a "recruit by genotype" approach, the researchers will perform detailed and specific analysis according to the individual's genetic variant. The study's main aims are to : 1) identify and describe biomarkers and cellular features in blood samples that occur because of the rare causal genetic variant; 2) study the altered physiology or cellular function that are due to the rare causal genetic variant. Participants will attend a study visit that will entail: * Consent * Data collection * Height and weight measures * Blood samples * MRI (optional), dependent on genotype and sub-study objectives. There is no treatment and the participants' normal clinical care will be unaffected and will continue uninterrupted. A small subset of participants may be invited for further sub-studies in the future. Researchers may recruit sex-matched healthy controls (without the variant of interest) with similar age and BMI (age: +/-15%, BMI: +/- 3 kg/m2) for specified case-control studies.
Trial Details
NCT Number NCT06478121
Lead Sponsor University of Exeter
Collaborators: Royal Devon and Exeter NHS Foundation Trust
Conditions
(from sponsor)
Diabetes Mellitus, Monogenic Diabetes, Hyperinsulinism
Related terms Diabetes Mellitus, Hyperinsulinism
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov