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

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called montelukast on kidney and heart function in people with type 1 diabetes who have early signs of kidney disease, specifically looking at protein levels in urine. High protein levels can indicate that the kidneys are not working properly, which is a common issue for those with diabetes. The trial aims to see if montelukast can help improve these kidney problems by reducing inflammation.

To be eligible for this study, participants need to be between 18 and 80 years old, have had type 1 diabetes for at least five years, and show specific signs of kidney issues, like a certain level of protein in their urine. They should also have stable blood pressure and be on certain medications for their diabetes. Participants will take montelukast and have regular check-ups to monitor their kidney and heart health throughout the trial. It's important to note that individuals with severe health issues or certain allergies may not be eligible to join. This study could provide valuable information on new ways to help manage kidney health in people with diabetes.

Gender

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Eligibility 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