Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Montelukast, Placebo.
- Who it may be relevant to
- Registry conditions: Albuminuria. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Montelukast
10mg daily - Other Placebo
1 capsule daily
Primary outcome measures
- Change in Albuminuria [Time frame: Baseline, 6 months]
Secondary outcome measures (2)
- Change in Brachial artery flow mediated dilation (FMD) [Time frame: Baseline, 6 months]
- Change in Large Elastic Artery Stiffness [Time frame: Baseline, 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT05498116 · 22-1027