SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in renal vascular resistance (RVR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-24 years
- •Tanner stage >2
- •Diabetes onset <18 years of age and <10 years duration prior to study start
- •HgbA1c <10%
- •Blood pressure <130/80 mm Hg prior to randomization
- •Stable anti-hypertensive regimen for at least one month prior to randomization
- •BMI < 40 kg/m2
- •If on SGLT2 inhibitor, ACEi/ARB or GLP-1RA, stable dose for 4 weeks
- •Patient or guardian able to provide consent
排除标准
- •Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days
- •Uncontrolled hypertension
- •eGFR <30 ml/min/1.73m2
- •Macroalbuminuria with urine albumin to creatinine ratio >300 mg/g
- •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
- •Iodine or shellfish allergy
研究组 & 干预措施
Placebo
干预措施: Montelukast Placebo (Drug)
Montelukast
干预措施: Montelukast (Drug)
结局指标
主要结局
Change in renal vascular resistance (RVR)
时间窗: 0 and 6 months
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).
次要结局
- Change in Brachial artery flow mediated dilation (FMD)(0 and 6 months)
- Change in aortic pulse-wave velocity (PWV)(0 and 6 months)
- Change in endovascular biopsy(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)