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Montelukast for Kidney, Eye, and Vascular Health in Type 2 Diabetes

This study is looking into whether montelukast, a medication currently used for asthma and allergies, can help improve kidney, eye, and blood vessel health in adults with type 2 diabetes and kidney disease. Diabetes can cause damage to these areas, and montelukast works by targeting certain inflammatory substances in the body. You might be able to join if you are between 18 and 80 years old, have type 2 diabetes, and have certain levels of kidney function (eGFR between 30-89 ml/min/1.73m2) and protein in your urine (urine albumin to creatinine ratio 30-5000 mg/g). The study will compare montelukast (10 mg by mouth daily) to a placebo (an inactive capsule). Researchers will measure changes in protein in your urine after 12 months to see if montelukast is effective. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 110 participants. It will compare montelukast to a placebo.
What's involved
You would take either montelukast or a placebo by mouth daily for 12 months. Your urine albumin excretion will be measured at the start and end of this 12-month period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, which is the duration of the treatment period.

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

NCT07685886

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Not Yet Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Colorado, Denver
~110 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:MontelukastPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in urine albumin excretion at 12 months
Measured over From enrollment to the end of treatment at 12 months

Conditions

Diabetes
Kidney Disease
Vascular Disease
Retinopathy

Explore related trials

Chronic Kidney DiseaseType 2 Diabetes Mellitus

NCT07685886

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Colorado Denver

    Aurora, Coloradostudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica Kendrick, MD MPH · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Jessica Kendrick, MD MPH
[email protected]
303-724-4837
Email the study team

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Eligibility criteria

Inclusion

Diabetes type 2
Urine albumin to creatinine ratio 30-5000 mg/g
CKD stage 2-3 (eGFR 30-89 ml/min/1.73m2)
Blood pressure \< 140/90 mmHg prior to randomization
BMI \< or = to 40 kg/m2
Use of ACEi or ARB with stable dose for 4 weeks
if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline
Able to provide consent

Exclusion

Type 1 diabetes
Uncontrolled hypertension
Hemoglobin A1C \>10%
Pregnancy or planning to become pregnant or currently breastfeeding
Allergy to aspirin
History of major psychiatric disorder
Use of inhaled or systemic corticosteroids or long-acting beta agonists
Proliferative retinopathy requiring current treatment

What this trial measures

  • Change from baseline in urine albumin excretion at 12 monthsFrom enrollment to the end of treatment at 12 months

    24-hour urine albumin