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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05498116
Collaborator
(none)
50
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Change in Albuminuria [Baseline, 6 months]

    Change in albuminuria from baseline to 6 months

Secondary Outcome Measures

  1. Change in Brachial artery flow mediated dilation (FMD) [Baseline, 6 months]

    Change in FMD from baseline to 6 months

  2. Change in Large Elastic Artery Stiffness [Baseline, 6 months]

    Change in aortic pulse wave velocity from baseline to 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Jessica Kendrick, MD, University of Colorado Denver | Anschutz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05498116
Other Study ID Numbers:
  • 22-1027
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Albuminuria
Montelukast

Study Results

No Results Posted as of Aug 11, 2022