NCT07409714

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1 type-2-diabetes

Timeline
40mo left

Started Aug 2026

Typical duration for early_phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Aug 2026Feb 2030

First Submitted

Initial submission to the registry

January 16, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

August 7, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3.5 years

First QC Date

January 16, 2026

Last Update Submit

September 8, 2026

Conditions

Type 2 Diabetes

Keywords

montelukastdiabetestype two diabeteskidney functionblood vessel functioninflammationsmart2d

Outcome Measures

Primary Outcomes (1)

  • 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).

    0 and 6 months

Secondary Outcomes (6)

  • Change in Brachial artery flow mediated dilation (FMD)

    0 and 6 months

  • Change in aortic pulse-wave velocity (PWV)

    0 and 6 months

  • Change in endovascular biopsy

    0 and 6 months

  • Change in urinary sCD163

    0 and 6 months

  • Change in urinary MCP-1

    0 and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Montelukast

EXPERIMENTAL
Drug: Montelukast

Placebo

PLACEBO COMPARATOR
Drug: Montelukast Placebo

Interventions

MontelukastDRUG

montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14

Montelukast
Montelukast PlaceboDRUG

one microcrystalline cellulose tablet daily

Placebo

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80010, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInflammation

Interventions

montelukast

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

February 13, 2026

Study Start

August 7, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Last Updated

September 9, 2026

Record last verified: 2026-09

Locations

US(1)