Diabetes, Kidney Disease, Retinopathy, Vascular Disease
Conditions
Brief summary
Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.
Interventions
DRUGMontelukast
10 my by mouth daily
DRUGPlacebo
One capsule by mouth 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
* Diabetes type 2 * Urine albumin to creatinine ratio 30-5000 mg/g * CKD stage 2-3 (eGFR 30-89 ml/min/1.73m2) * Blood pressure \< 140/90 mmHg prior to randomization * BMI \< or = to 40 kg/m2 * Use of ACEi or ARB with stable dose for 4 weeks * if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline * Able to provide consent
Exclusion criteria
* Type 1 diabetes * Uncontrolled hypertension * Hemoglobin A1C \>10% * Pregnancy or planning to become pregnant or currently breastfeeding * Allergy to aspirin * History of major psychiatric disorder * Use of inhaled or systemic corticosteroids or long-acting beta agonists * Proliferative retinopathy requiring current treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in urine albumin excretion at 12 months | From enrollment to the end of treatment at 12 months | 24-hour urine albumin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in creatinine clearance at 12 months | From time of enrollment until end of treatment at 12 months | — |
| Change from baseline in vascular endothelial function at 12 months | From enrollment to the end of treatment at 12 months | Measured by brachial artery flow mediated dilation |
| Change from baseline in arterial stiffness at 12 months | From enrollment until end of treatment at 12 months | Measured by aortic pulse wave velocity |
| Change from baseline in diabetic retinopathy at 12 months | From enrollment until to the end of treatment at 12 months | Measured by OCTA |
Countries
United States
Contacts
CONTACTJessica Kendrick, MD MPH
PRINCIPAL_INVESTIGATORJessica Kendrick, MD MPH
University of Colorado, Denver
Outcome results
None listed