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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Jessica Kendrick
Jessica.Kendrick@cuanschutz.edu
3037244837
Time Frame
Start Date: 2023-01-26
Estimated Completion Date: 2025-10
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Placebo
One capsule daily
Experimental: Montelukast
One 10mg capsule daily
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov