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Not yet recruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

CO