RecruitingPhase 4NCT05498116

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


Sponsor

University of Colorado, Denver

Enrollment

50 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called montelukast (commonly used for asthma and allergies) can protect the kidneys and blood vessels in people with type 1 diabetes who already show early signs of kidney damage. **You may be eligible if...** - You are between 18 and 80 years old with type 1 diabetes for at least 5 years - You have early signs of kidney disease (protein in your urine) - Your kidney function is mildly to moderately reduced - You are already on a blood pressure medication (ACE inhibitor or ARB) at a stable dose - Your blood pressure is under 140/90 **You may NOT be eligible if...** - Your kidney function is severely reduced - You exercise vigorously more than twice a week - Your BMI is 40 or above - Your blood pressure or insulin regimen has changed recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMontelukast

10mg daily

OTHERPlacebo

1 capsule daily


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT05498116


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