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Montelukast for Kidney and Vascular Function in Type 1 Diabetes

This study is investigating if Montelukast, a medication typically used for allergies, can help people with type 1 diabetes and kidney disease. Kidney disease is a common problem for people with type 1 diabetes, and this study aims to see if Montelukast can lower the amount of protein in your urine (a sign of kidney damage) and improve how well your kidneys and blood vessels work. You may be able to join if you are 18-80 years old, have had type 1 diabetes for at least 5 years, and have certain levels of protein in your urine and kidney function (eGFR). The study is looking for 50 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 50 participants. You would receive either Montelukast (10mg daily) or a placebo (an inactive capsule daily).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your albuminuria will be measured at the beginning of the study and again at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05498116

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

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Colorado, Denver
~50 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:MontelukastPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Albuminuria
Measured over Baseline, 6 months

Conditions

Albuminuria

Explore related trials

AlbuminuriaType 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Jessica Kendrick, MD · PRINCIPAL_INVESTIGATOR · University of Colorado Denver | Anschutz

Who to contact

Jessica Kendrick
[email protected]
3037244837
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in AlbuminuriaBaseline, 6 months

    Change in albuminuria from baseline to 6 months