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Genetics of Insulin and Incretins in Cystic Fibrosis

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
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Record History

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  1. Primary and study completion pushed from Jul 2026 to Jul 2027 Show 4 more changesShow less
    • Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia
    • Study description revised
    • Site details revised at 1 of 2 sites
    • Eligibility criteria expanded, about 3 words
  2. Primary and study completion dates: Jul 2025 to Jul 2026v18
  3. 2 versions Re-verified since Aug 10, 2023, no change to tracked fieldsv16-v17
  4. Trial status: Active, Not Recruiting to Recruitingv15 Show 7 more changesShow less
    • Primary completion date: Jul 2024 to Jul 2025
    • Study completion date: Jun 2025 to Jul 2025
    • Interventions: Blood or Saliva Sample Collection (Genetic), Glucose -potentiated arginine (GPA) stimulation tests (Other) to Blood or Saliva Sample Collection (Genetic)
    • Eligibility criteria shortened, about 215 words
    • Secondary endpoints shortened, about 6 words
    • Study description shortened, about 71 words
    • Site details revised at 2 of 2 sites
  5. Enrollment target: 350 to 550v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Jul 2020 to Jul 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2021 to Jun 2025
    • Site details revised at 2 of 2 sites
    v13
  2. Primary completion date: Jul 2019 to Jul 2020v12
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: Jul 2018 to Jul 2019v10
  5. Primary completion date: Jul 2017 to Jul 2018v9
  6. Primary completion date: Jun 2017 to Jul 2017v8
  7. Re-verified, no change to tracked fieldsv7
  8. Primary completion date: Jun 2016 to Jun 2017v6
  9. Re-verified, no change to tracked fieldsv5
  10. Eligibility criteria expanded, about 3 wordsv4
  11. Interventions: Blood or Saliva Sample Collection (Genetic), Glucose -potentiated arginine (GPA) stimulation tests (Other)v3
  12. Eligibility criteria expanded, about 2 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cystic fibrosis related diabetes (CFRD) is associated with worse CF-relevant outcomes. The mechanisms underlying CFRD development are not fully understood, but recent evidence suggests Type 2 Diabetes Mellitus (T2DM) mechanisms may be involved and may involve incretins (gut secreted hormones that augment insulin secretion in response to a nutrient load). This study will examine the prevalence of Genome wide association study (GWAS)-implicated T2DM alleles (including TCF7L2) across the spectrum of glucose abnormalities in CF and will use this information to compare incretin and insulin secretion in non-diabetic children and adults with high risk and low risk alleles.
Trial Details
NCT Number NCT01852448
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: University of Pennsylvania
Conditions
(from sponsor)		 Cystic Fibrosis
Related terms Cystic Fibrosis
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov