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 re
| Condition(s) | Albuminuria |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 meas |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | University of Colorado, Denver |
| Locations | Aurora, Colorado, United States |
| Start date | 2023-01-26 |
| NCT ID | NCT05498116 |
| Official listing | https://clinicaltrials.gov/study/NCT05498116 |