Montelukast's effects on kidney and blood vessel health in teens and young adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study will test montelukast, a leukotriene inhibitor, versus placebo in youths and young adults with type 2 diabetes to see if it can improve kidney and vascular function. Eligible participants are ages 14-24 with recent diabetes onset and controlled blood pressure and BMI without severe organ impairment. The trial uses a randomized design with montelukast and a placebo, monitoring kidney function and vascular health as primary avenues of effect. Results could guide future strategies to reduce diabetes-related kidney and cardiovascular complications. Safety and tolerability will also be assessed in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 14-24 years
* Tanner stage \>2
* Diabetes onset \<18 years of age and \<10 years duration prior to study start
* HgbA1c \<10%
* Blood pressure \<130/80 mm Hg prior to randomization
* Stable anti-hypertensive regimen for at least one month prior to randomization
* BMI \< 40 kg/m2
* If on SGLT2 inhibitor, ACEi/ARB or GLP-1RA, stable dose for 4 weeks
* Patient or guardian able to provide consent

Exclusion Criteria:

* T1D
* Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days
* Uncontrolled hypertension
* eGFR \<30 ml/min/1.73m2
* Macroalbuminuria with urine albumin to creatinine ratio \>300 mg/g
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Allergy to aspirin
* Severe hepatic impairment (Child-Pugh Class C)
* History of major psychiatric disorder
* Use of inhaled or systemic corticosteroids or long-acting beta agonists
* Iodine or shellfish allergy

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.