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

NCT07409714 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 25-2690
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

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

Study Arms (2)

Montelukast

EXPERIMENTAL

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Drug: Montelukast Placebo

Interventions

Montelukast DRUG

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

Montelukast

Montelukast Placebo DRUG

one microcrystalline cellulose tablet daily

Placebo

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

montelukast

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: July 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05