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

NCT05498116 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-1027
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Albuminuria

  Change in albuminuria from baseline to 6 months

  Baseline, 6 months

Secondary Outcomes (2)

• Change in Brachial artery flow mediated dilation (FMD)

  Baseline, 6 months

• Change in Large Elastic Artery Stiffness

  Baseline, 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One capsule daily

Other: Placebo

Montelukast

EXPERIMENTAL

One 10mg capsule daily

Drug: Montelukast

Interventions

Montelukast DRUG

10mg daily

Montelukast

Placebo OTHER

1 capsule daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Albuminuria

Interventions

montelukast

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Kendrick, MD

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Kendrick

CONTACT

3037244837; Jessica.Kendrick@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: January 26, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)