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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachial artery flow mediated dilation (FMD) | Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography | 0 and 6 months |
| Change in aortic pulse-wave velocity (PWV) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Montelukast Placebo | Drug | one microcrystalline cellulose tablet daily |
|
Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer
| 0 and 6 months |
| 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. | 0 and 6 months |
| Change in urinary sCD163 | 0 and 6 months |
| Change in urinary MCP-1 | 0 and 6 months |
| Change in plasma MCP-1 | 0 and 6 months |
| D004700 | Endocrine System Diseases |