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

Phase 4

Recruiting

• Conditions: Albuminuria
• Interventions: Other: Placebo; Drug: Montelukast

• Registration Number: NCT05498116
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2023-01-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One capsule daily
Montelukast	Montelukast	One 10mg capsule daily

Primary Outcome Measures

Name	Time	Method
Change in Albuminuria	Baseline, 6 months	Change in albuminuria from baseline to 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States