Actively Recruiting
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Led by University of Colorado, Denver · Updated on 2025-05-29
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Kidney disease is a common complication in people with type 1 diabetes, often leading to serious health issues like disability and early death. Researchers are studying whether montelukast, a drug that blocks leukotrienes which are inflammatory chemicals involved in allergic reactions, can reduce protein levels in urine—a sign of early kidney disease—and improve kidney and heart function in people with type 1 diabetes and kidney disease. This is a phase 4 randomized clinical trial aiming to explore these effects in detail. Participants will receive either one 10mg capsule of montelukast daily or a placebo capsule daily. The treatment period lasts for 6 months, during which the participants will be monitored to assess changes in their kidney and vascular function. The study uses a quadruple masking design to ensure unbiased results. The intervention focuses on evaluating montelukast’s impact on albuminuria, arterial dilation, and artery stiffness compared to placebo. During the study, participants will have their urine albumin levels and vascular function measured at the start and after 6 months of treatment. Researchers will also monitor blood pressure, kidney filtration rate, and other health indicators. Participants are required to maintain stable insulin and blood pressure treatments and have limited vigorous exercise before and during the study. The total duration of involvement is about 6 months, with assessments to track kidney and cardiovascular health changes under the study treatments.
CONDITIONS
Brief Title
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Diagnosis of type 1 diabetes for at least 5 years
- Urine albumin to creatinine ratio between 30 and 5000 mg/g on first morning urine
- Estimated glomerular filtration rate (eGFR) between 30 and 89 ml/min/1.73m2 at screening
- Blood pressure below 140/90 mm Hg before randomization
- Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for at least 4 weeks
- Body mass index (BMI) below 40 kg/m2
- Stable anti-hypertensive medication regimen for at least 1 month before randomization
- Stable insulin delivery method (automated insulin delivery system or multiple daily injections) for at least 4 weeks before randomization
- Sedentary or recreationally active with two or fewer days of vigorous aerobic exercise per week
- Able to provide informed consent
You will not qualify if you...
- Significant other health conditions with life expectancy less than 1 year
- Uncontrolled high blood pressure
- Factors limiting ability to follow study treatments
- Expected to start dialysis or receive kidney transplant within 6 months
- Currently enrolled in another research study
- Pregnant, planning pregnancy, or breastfeeding
- Allergy to aspirin
- Severe liver impairment (Child-Pugh Class C)
- History of major psychiatric disorder
- Use of inhaled or systemic corticosteroids or long-acting beta agonists
- Allergy to penicillin, iodine, or shellfish
- Current use of phenobarbital, rifampin, or carbamazepine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants take Montelukast or placebo daily to assess effects on kidney and vascular function.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Kendrick
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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