MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07685886
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • Kidney Disease
  • Retinopathy
  • Vascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Montelukast — DRUG
    10 my by mouth daily
  • Placebo — DRUG
    One capsule by mouth daily

Study Details

Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Montelukast
    10 mg capsule by mouth daily
  • Placebo Comparator: Placebo
    One matching capsule by mouth daily

Primary Outcome Measure

Change from baseline in urine albumin excretion at 12 months [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045
Jessica Kendrick
[email protected]
303-724-4837
[email protected]

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By research site
University of Colorado Denver· Aurora, CO

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