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SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Feb 2030 → Dec 2030
See other at-risk trials from University of Colorado, Denver

Record History

  1. Re-verified, no change to tracked fields
  2. Primary completion pushed from Feb 2030 to Dec 2030 Start date pushed from Aug 7, 2026 to Oct 12, 2026 · Completion pushed from Feb 2030 to Dec 2031 · Eligibility criteria expanded, about 11 words · 2 more Show 5 more changesShow less
    • Start date pushed from Aug 7, 2026 to Oct 12, 2026
    • Completion pushed from Feb 2030 to Dec 2031
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site contact updated
  3. Recruitment opened Start date changed from estimate of Jul 2026 to Aug 7, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Jul 2026 to Aug 7, 2026
  4. Start date: Feb 2026 to Jul 2026v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.
Trial Details
NCT Number NCT07409714
Lead Sponsor University of Colorado, Denver
Conditions Type 2 Diabetes
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov