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Could an asthma drug shield young hearts and kidneys from diabetes damage?

NCT ID NCT07409714

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests whether montelukast, a medicine used for asthma, can help protect the kidneys and blood vessels in 50 teens and young adults (ages 14-24) with type 2 diabetes. The drug works by blocking harmful inflammatory chemicals linked to diabetes complications. Researchers will measure changes in kidney blood flow and artery health over 6 months to see if this approach could reduce long-term risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Inflammation type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80010, United States

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