MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 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: Diabetes, Kidney Disease, Vascular Disease, Retinopathy. 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 →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Montelukast
10 my by mouth daily - Drug Placebo
One capsule by mouth daily
Primary outcome measures
- Change from baseline in urine albumin excretion at 12 months [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (4)
- Change from baseline in creatinine clearance at 12 months [Time frame: From time of enrollment until end of treatment at 12 months]
- Change from baseline in vascular endothelial function at 12 months [Time frame: From enrollment to the end of treatment at 12 months]
- Change from baseline in arterial stiffness at 12 months [Time frame: From enrollment until end of treatment at 12 months]
- Change from baseline in diabetic retinopathy at 12 months [Time frame: From enrollment until to the end of treatment at 12 months]
Eligibility criteria
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
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 Denver — Aurora
Identifiers
NCT: NCT07685886 · 26-1415