Montelukast's effect on kidney and vascular health in type 1 diabetes

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

This study is testing if the medication montelukast can help improve kidney and heart health in adults with type 1 diabetes who have early signs of kidney problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05498116 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of montelukast, a leukotriene receptor antagonist, on kidney and cardiovascular function in individuals with type 1 diabetes who exhibit early signs of kidney disease, specifically albuminuria. Participants will be randomized to receive either montelukast or a placebo, and the primary outcome will be the reduction of protein levels in urine, which indicates kidney function. The study aims to determine if targeting inflammation can slow the progression of diabetic kidney disease. Eligible participants include adults aged 18-80 with a history of type 1 diabetes and specific kidney function parameters.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with type 1 diabetes for at least 5 years and evidence of early kidney disease.

Not a fit: Patients with significant comorbid conditions or uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of kidney disease in patients with type 1 diabetes, potentially reducing the need for dialysis and improving overall health outcomes.

How similar studies have performed: While targeting inflammation in diabetic kidney disease is a promising approach, the specific use of montelukast in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Age 18-80 years
* Type 1 diabetes for at least 5 years
* Urine albumin to creatinine ratio 30-5000 mg/g on first morning void
* eGFR 30-89 ml/min/1.73m2 at time of screening
* Blood pressure \<140/90 mm Hg prior to randomization
* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
* BMI \< 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients).
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization
* Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
* Able to provide consent

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 6 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Allergy to aspirin
* Severe hepatic impairment (Child-Pugh Class C)
* History of major psychiatric disorder
* Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
* Penicillin allergy
* Iodine allergy
* Shellfish allergy
* Current use of phenobarbital, rifampin or carbamazepine

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Jessica Kendrick, MD — University of Colorado Denver | Anschutz
• Study coordinator: Jessica Kendrick

Conditions Albuminuria