Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05498116
Phase
PHASE4
Status
Recruiting
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Conditions

  • Albuminuria

Eligibility Criteria

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

Interventions

  • Montelukast — DRUG
    10mg daily
  • Placebo — OTHER
    1 capsule daily

Study Details

Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.

Key Dates

Start date
Jan 26, 2023
Status verified
May 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

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

Arms

  • Placebo Comparator: Placebo
    One capsule daily
  • Experimental: Montelukast
    One 10mg capsule daily

Primary Outcome Measure

Change in Albuminuria [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Jessica Kendrick, MD
[email protected]
303-724-4837

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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