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.

Study Overview

• Status: Recruiting
• Conditions: Albuminuria
• Intervention / Treatment: Other: Placebo; Drug: Montelukast

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Kendrick; Phone Number: 3037244837; Email: Jessica.Kendrick@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Jessica Kendrick, MD; Phone Number: 303-724-4837; Email: jessica.kendrick@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; One capsule daily	Other: Placebo; 1 capsule daily
Experimental: Montelukast; One 10mg capsule daily	Drug: Montelukast; 10mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Albuminuria	Change in albuminuria from baseline to 6 months	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brachial artery flow mediated dilation (FMD)	Change in FMD from baseline to 6 months	Baseline, 6 months
Change in Large Elastic Artery Stiffness	Change in aortic pulse wave velocity from baseline to 6 months	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jessica Kendrick, MD, University of Colorado Denver | Anschutz

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Proteinuria; Albuminuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP1A2 Inducers; Leukotriene Antagonists; Montelukast
• Other Study ID Numbers: 22-1027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes