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

NCT ID: NCT05498116

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2025-10-31

Brief Summary

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.

Conditions

Albuminuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

One capsule daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

1 capsule daily

Montelukast

One 10mg capsule daily

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

10mg daily

Interventions

Montelukast

10mg daily

Intervention Type: DRUG

Placebo

1 capsule daily

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Kendrick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Kendrick

Role: CONTACT

Jessica.Kendrick@cuanschutz.edu

3037244837

Facility Contacts

Jessica Kendrick, MD

Role: primary

jessica.kendrick@cuanschutz.edu

303-724-4837

Other Identifiers

22-1027

Identifier Type: -

Identifier Source: org_study_id