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
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 sample
- 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 blood pressure medication regimen for at least one 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 no more than 2 days of vigorous aerobic exercise per week
- Able to provide informed consent
You will not qualify if you...
- Significant other health conditions that reduce life expectancy to less than 1 year
- Uncontrolled high blood pressure
- Factors that may limit following the study treatments
- Expected to start dialysis or receive a kidney transplant within 6 months
- Currently participating 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
- Allergies to penicillin, iodine, or shellfish
- Current use of phenobarbital, rifampin, or carbamazepine
AI-Screening
AI-Powered Screening
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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
CONTACT
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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