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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status and phase

Enrolling
Phase 4

Conditions

Albuminuria

Treatments

Drug: Montelukast
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05498116
22-1027

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
One capsule daily
Treatment:
Other: Placebo
Montelukast
Experimental group
Description:
One 10mg capsule daily
Treatment:
Drug: Montelukast

Trial contacts and locations

0

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Central trial contact

Jessica Kendrick

Data sourced from clinicaltrials.gov

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