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NCT Number: NCT07409714

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Colorado

Aurora, Colorado, 80010, United States

Location status: Recruiting

Location contact

Angelina Dixon

CONTACT

[email protected]

7204413194

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

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

Montelukast Placebo

Drug

one microcrystalline cellulose tablet daily

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in Brachial artery flow mediated dilation (FMD)

    Time frame: 0 and 6 months

    Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography

  2. Change in aortic pulse-wave velocity (PWV)

    Time frame: 0 and 6 months

    Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer

  3. Change in endovascular biopsy

    Time frame: 0 and 6 months

    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.

  4. Change in urinary sCD163

    Time frame: 0 and 6 months

  5. Change in urinary MCP-1

    Time frame: 0 and 6 months

  6. Change in plasma MCP-1

    Time frame: 0 and 6 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 13, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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