Albuminuria
Conditions
Brief 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.
Interventions
DRUGMontelukast
10mg daily
OTHERPlacebo
1 capsule daily
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Albuminuria | Baseline, 6 months | Change in albuminuria from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brachial artery flow mediated dilation (FMD) | Baseline, 6 months | Change in FMD from baseline to 6 months |
| Change in Large Elastic Artery Stiffness | Baseline, 6 months | Change in aortic pulse wave velocity from baseline to 6 months |
Countries
United States
Contacts
CONTACTJessica Kendrick
PRINCIPAL_INVESTIGATORJessica Kendrick, MD
University of Colorado Denver | Anschutz
Outcome results
None listed