Testing Montelukast for Kidney Protein Leakage in Type 1 Diabetes
Tests montelukast against placebo in adults with type 1 diabetes and kidney protein leakage.
Plain-language title generated from the registry record
Registry title: Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Key facts
- Where
- Aurora, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05498116, who can take part
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT05498116
- Record updated
- 30 June 2026
- Original description
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.Read full original descriptionShow less
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
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.
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: 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); 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; 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.