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Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT05498116
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Albuminuria Drug: Montelukast Other: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
Actual Study Start Date : January 26, 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Montelukast

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
One capsule daily
 Other: Placebo
1 capsule daily
Experimental: Montelukast
One 10mg capsule daily
 Drug: Montelukast
10mg daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in Albuminuria [ Time Frame: Baseline, 6 months ]
    Change in albuminuria from baseline to 6 months


Secondary Outcome Measures :
  1. Change in Brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline, 6 months ]
    Change in FMD from baseline to 6 months

  2. Change in Large Elastic Artery Stiffness [ Time Frame: Baseline, 6 months ]
    Change in aortic pulse wave velocity from baseline to 6 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05498116


Contacts
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Contact: Jessica Kendrick 3037244837 Jessica.Kendrick@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Jessica Kendrick, MD    303-724-4837    jessica.kendrick@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jessica Kendrick, MD University of Colorado Denver | Anschutz
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05498116    
Other Study ID Numbers: 22-1027
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations
Montelukast
 Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action