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SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age14-24
SponsorUniversity of Colorado, Denver

About this trial

Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 14-24 years

Tanner stage >2

Diabetes onset <18 years of age and <10 years duration prior to study start

HgbA1c <10%

Disqualifiers

T1D

Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days

Uncontrolled hypertension

eGFR <30 ml/min/1.73m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Montelukast

    Drug

    montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14

  • Montelukast Placebo

    Drug

    one microcrystalline cellulose tablet daily

Treatment groups

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

Trial outcomes

Primary outcomes

1

Change in renal vascular resistance (RVR)

Change in RVR from baseline to 6 months. RVR is calculated as mean arterial pressure (MAP)/renal blood flow (RBF). MAP is measured using a blood pressure cuff and RBF is calculated using p-aminohippurate clearance (PAH clearance).

Time frame
0 and 6 months

Secondary outcomes

1

Change in Brachial artery flow mediated dilation (FMD)

Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography

Time frame
0 and 6 months
2

Change in aortic pulse-wave velocity (PWV)

Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer

Time frame
0 and 6 months
3

Change in endovascular biopsy

Change in endovascular biopsy from baseline to 6 months. Venous endothelial cells will be collected from the intima of the vessel using 2 sterile J-wires advanced and retracted through an 18-gauge catheter, then will be incubated with monoclonal antibodies for Nf-KB.

Time frame
0 and 6 months
4

Change in urinary sCD163

Time frame
0 and 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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