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

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