Effect of Montelukast on Kidney and Vascular Function in... | NCT05498116

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

NCT05498116

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Jun 30, 2026Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Albuminuria

Interventions

Montelukast
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2023Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Aug 9, 2022

First Submission Date that Met QC Criteria

Aug 9, 2022

First Posted Date

Aug 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jun 30, 2026Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	One capsule daily	Other: Placebo
Montelukast	Experimental	One 10mg capsule daily	Drug: Montelukast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug	10mg daily	Montelukast
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Albuminuria	Change in albuminuria from baseline to 6 months	Baseline, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Brachial artery flow mediated dilation (FMD)	Change in FMD from baseline to 6 months	Baseline, 6 months
Change in Large Elastic Artery Stiffness	Change in aortic pulse wave velocity from baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011507	Proteinuria
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases