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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Montelukast

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