MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
University of Colorado, Denver
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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…
Interventions
- DrugMontelukast
10 my by mouth daily
- DrugPlacebo
One capsule by mouth daily
Location
- University of Colorado DenverAurora, Colorado