Health TrialsbyHealthPanel

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

ConditionAlbuminuria
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Montelukast

    Drug

    10mg daily

  • Placebo

    Other intervention

    1 capsule daily

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: MontelukastExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Albuminuria

Change in albuminuria from baseline to 6 months

Time frame
Baseline, 6 months

Secondary outcomes

1

Change in Brachial artery flow mediated dilation (FMD)

Change in FMD from baseline to 6 months

Time frame
Baseline, 6 months
2

Change in Large Elastic Artery Stiffness

Change in aortic pulse wave velocity from baseline to 6 months

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov
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