NCT05498116RecruitingPhase 4
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Aug 2022
- Start date
- 26 Jan 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 1 diabetes
- NCT number
- NCT05498116
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 26 Jan 2023 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated initiation of dialysis or kidney transplantation within 6 months
- Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
Other illness
- Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- Uncontrolled hypertension
- Allergy to aspirin
- Severe hepatic impairment (Child-Pugh Class C)
- History of major psychiatric disorder
- Penicillin allergy
- Iodine allergy
- Shellfish allergy
Other
- Factors judged to limit adherence to interventions
- Current participation in another research study
- Pregnancy or planning to become pregnant or currently breastfeeding
- Current use of phenobarbital, rifampin or carbamazepine
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.