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RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 24 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how montelukast affects the kidneys and blood vessels in teens and young adults with type 2 diabetes. The drug blocks substances that cause swelling and damage. The goal is to help guide future diabetes care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 14–24 and past stage 2 of puberty.
  • Type 2 diabetes started before age 18 and less than 10 years before the study.
  • A1c, a measure of average blood sugar, below 10%.
  • Blood pressure below 130/80 before treatment is assigned.
  • Blood pressure medicines unchanged for at least 1 month before treatment is assigned.
  • Body mass index (BMI), a measure of weight compared with height, below 40.
  • If taking an SGLT2 inhibitor, ACE inhibitor, ARB, or GLP-1 medicine, the dose must be unchanged for 4 weeks.
  • You or your guardian can give consent to join.

Who can't join

  • Type 1 diabetes, or a severe high-blood-sugar emergency called ketoacidosis or hyperosmolar hyperglycemia in the past 60 days.
  • Blood pressure that is not controlled.
  • Kidney filtering test (eGFR) below 30, or urine protein-to-creatinine ratio above 300 mg/g.
  • Currently in another research study.
  • Pregnant, planning pregnancy, or breastfeeding.
  • Allergy to aspirin, iodine, or shellfish.
  • Severe liver disease (Child-Pugh class C), or a history of a major mental health disorder.
  • Use of inhaled or whole-body steroid medicines, or long-acting beta agonists, which help open the airways.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CO