Type 2 Diabetes study: Montelukast
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
What this study is testing
What is Montelukast?
Montelukast is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 24
You may be able to join 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.