MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Phase 4Not Yet RecruitingNCT07685886

University of Colorado, Denver110 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Diabetes Kidney Disease Vascular Disease Retinopathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in urine albumin excretion at 12 months

24-hour urine albumin

Time frame: From enrollment to the end of treatment at 12 months

Secondary Outcomes

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

Measured by brachial artery flow mediated dilation

Time frame: From enrollment to the end of treatment at 12 months

Change from baseline in arterial stiffness at 12 months

Measured by aortic pulse wave velocity

Time frame: From enrollment until end of treatment at 12 months

Change from baseline in diabetic retinopathy at 12 months

Measured by OCTA

Time frame: From enrollment until to the end of treatment at 12 months