MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type 1 diabetes
Uncontrolled hypertension
Hemoglobin A1C >10%
Pregnancy or planning to become pregnant or currently breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Montelukast
Drug10 my by mouth daily
Placebo
DrugOne capsule by mouth daily
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: MontelukastExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Change from baseline in creatinine clearance at 12 months
Time frame
From time of enrollment until end of treatment at 12 months2
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 months3
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 months4
Change from baseline in diabetic retinopathy at 12 months
Measured by OCTA
Time frame
From enrollment until to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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