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RecruitingPhase 4

Effect of Montelukast on Kidney and Vascular Function in Type 1 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
18 Years to 80 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 whether montelukast, a drug that blocks certain chemicals that cause inflammation, lowers protein in the urine. It also tests whether the drug improves kidney, heart, and blood vessel function in adults with type 1 diabetes and kidney disease.

Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.

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

Eligibility

Who can join

  • Age 18–80 and have had type 1 diabetes for at least 5 years.
  • First morning urine test shows an albumin-to-creatinine ratio of 30–5000 mg/g, a measure of protein in urine.
  • Kidney filtering test (eGFR) is 30–89 ml/min/1.73 m² at screening.
  • Blood pressure is below 140/90 before study group assignment, with no changes to blood pressure medicines for at least 1 month.
  • Take an ACE inhibitor or ARB, types of blood pressure medicine, at the same dose for at least 4 weeks.
  • Body mass index (BMI), a measure of weight compared with height, is below 40.
  • Have used the same insulin delivery plan, such as an automated system or daily shots, for at least 4 weeks before study group assignment.
  • Do little or recreational exercise, with vigorous aerobic exercise on no more than 2 days, and can give consent to join.

Who can't join

  • Have a serious health condition that the study doctor thinks may limit life to less than 1 year, or have uncontrolled high blood pressure.
  • Have factors that the study team believes would make it hard to follow the study plan.
  • Expect to start dialysis, a treatment that filters blood, or have a kidney transplant within 6 months.
  • Are in another research study, are pregnant, plan to become pregnant, or are breastfeeding.
  • Are allergic to aspirin, penicillin, iodine, or shellfish.
  • Have severe liver problems (Child-Pugh Class C) or a history of a major mental health disorder.
  • Use inhaled steroids, steroids that affect the whole body, or long-acting beta agonists, medicines that help open the airways.
  • Currently take phenobarbital, rifampin, or carbamazepine.

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

Official eligibility criteria

Inclusion Criteria: * Age 18-80 years * Type 1 diabetes for at least 5 years * Urine albumin to creatinine ratio 30-5000 mg/g on first morning void * eGFR 30-89 ml/min/1.73m2 at time of screening * Blood pressure \<140/90 mm Hg prior to randomization * Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks * BMI \< 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients). * Stable anti-hypertensive regimen for at least one month prior to randomization * Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization * Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements) * Able to provide consent Exclusion Criteria: * Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * Uncontrolled hypertension * Factors judged to limit adherence to interventions * Anticipated initiation of dialysis or kidney transplantation within 6 months * 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 (higher risk of neuropsychiatric reaction) * Penicillin allergy * Iodine allergy * Shellfish allergy * Current use of phenobarbital, rifampin or carbamazepine

Study sites (1)

CO