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

Primary Purpose

Albuminuria

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Montelukast

Placebo

About this trial

This is an interventional treatment trial for Albuminuria

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Montelukast

Arm Description

One capsule daily

One 10mg capsule daily

Outcomes

Primary Outcome Measures

Change in Albuminuria

Change in albuminuria from baseline to 6 months

Secondary Outcome Measures

Change in Brachial artery flow mediated dilation (FMD)

Change in FMD from baseline to 6 months

Change in Large Elastic Artery Stiffness

Change in aortic pulse wave velocity from baseline to 6 months

Full Information

NCT ID

NCT05498116

First Posted

August 9, 2022

Last Updated

April 18, 2023

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT05498116

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Albuminuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

One capsule daily

Arm Title

Montelukast

Arm Type

Experimental

Arm Description

One 10mg capsule daily

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Description

10mg daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

1 capsule daily

Primary Outcome Measure Information:

Title

Change in Albuminuria

Description

Change in albuminuria from baseline to 6 months

Time Frame

Baseline, 6 months

Secondary Outcome Measure Information:

Title

Change in Brachial artery flow mediated dilation (FMD)

Description

Change in FMD from baseline to 6 months

Time Frame

Baseline, 6 months

Title

Change in Large Elastic Artery Stiffness

Description

Change in aortic pulse wave velocity from baseline to 6 months

Time Frame

Baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Kendrick

Phone

3037244837

Jessica.Kendrick@cuanschutz.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Kendrick, MD

Organizational Affiliation

University of Colorado Denver | Anschutz

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Kendrick, MD

Phone

303-724-4837

jessica.kendrick@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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