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

Description

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.

Conditions

Albuminuria

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Albuminuria
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Jessica Kendrick, MD, PRINCIPAL_INVESTIGATOR, University of Colorado Denver | Anschutz

Study Record Dates

2025-10