Type 2 DiabetesEarly Phase 1NCT07409714
SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
A Early Phase 1 study testing Montelukast in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other… Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to Dec 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80010
Angelina Dixon, 720-441-3194, angelina.dixon@cuanschutz.edu
About this study
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.
- Conditions
- Type 2 Diabetes
- Being tested
- Montelukast, Montelukast Placebo
- Keywords
- montelukast, diabetes, type two diabetes, kidney function, blood vessel function, inflammation, smart2d
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
Montelukast PlaceboDrug
one microcrystalline cellulose tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Not described Receives: Drug: Montelukast |
| Placebo | Placebo comparator | Not described Receives: Drug: Montelukast Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal vascular resistance (RVR)
Change in RVR from baseline to 6 months. RVR is calculated as mean arterial pressure (MAP)/renal blood flow (RBF). MAP is measured using a blood pressure cuff and RBF is calculated using p-aminohippurate clearance (PAH clearance).
Measured: 0 and 6 months
Secondary outcomes (6)
Change in Brachial artery flow mediated dilation (FMD)
Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography
Measured: 0 and 6 months
Change in aortic pulse-wave velocity (PWV)
Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer
Measured: 0 and 6 months
Change in endovascular biopsy
Change in endovascular biopsy from baseline to 6 months. Venous endothelial cells will be collected from the intima of the vessel using 2 sterile J-wires advanced and retracted through an 18-gauge catheter, then will be incubated with monoclonal antibodies for Nf-KB.
Measured: 0 and 6 months
Change in urinary sCD163
Measured: 0 and 6 months
Change in urinary MCP-1
Measured: 0 and 6 months
Change in plasma MCP-1
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start12 Oct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409714
- Sponsor's protocol ID
- 25-2690
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07409714
- Acronym / sponsor ID
- 25-2690
- Conditions
- Type 2 Diabetes
- Keywords
- montelukast, diabetes, type two diabetes, kidney function, blood vessel function, inflammation, smart2d
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast |
| Placebo | Placebo comparator | Drug: Montelukast Placebo |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukastmontelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14 | Drug | Montelukast |
| Montelukast Placeboone microcrystalline cellulose tablet daily | Drug | Placebo |
Primary outcome
Change in renal vascular resistance (RVR)
Time frame: 0 and 6 months
Change in RVR from baseline to 6 months. RVR is calculated as mean arterial pressure (MAP)/renal blood flow (RBF). MAP is measured using a blood pressure cuff and RBF is calculated using p-aminohippurate clearance (PAH clearance).
6 secondary outcomes
Change in Brachial artery flow mediated dilation (FMD)
Time frame: 0 and 6 months
Change in aortic pulse-wave velocity (PWV)
Time frame: 0 and 6 months
Change in endovascular biopsy
Time frame: 0 and 6 months
Change in urinary sCD163
Time frame: 0 and 6 months
Change in urinary MCP-1
Time frame: 0 and 6 months
Change in plasma MCP-1
Time frame: 0 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Montelukast in people with Type 2 Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal vascular resistance (RVR) (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.