MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change from baseline in urine albumin excretion at 12 months
研究概览
简要总结
Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 2
- •Urine albumin to creatinine ratio 30-5000 mg/g
- •CKD stage 2-3 (eGFR 30-89 ml/min/1.73m2)
- •Blood pressure < 140/90 mmHg prior to randomization
- •BMI < or = to 40 kg/m2
- •Use of ACEi or ARB with stable dose for 4 weeks
- •if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline
- •Able to provide consent
排除标准
- •Type 1 diabetes
- •Uncontrolled hypertension
- •Hemoglobin A1C >10%
- •Pregnancy or planning to become pregnant or currently breastfeeding
- •Allergy to aspirin
- •History of major psychiatric disorder
- •Use of inhaled or systemic corticosteroids or long-acting beta agonists
- •Proliferative retinopathy requiring current treatment
结局指标
主要结局
Change from baseline in urine albumin excretion at 12 months
时间窗: From enrollment to the end of treatment at 12 months
24-hour urine albumin
次要结局
- Change from baseline in creatinine clearance at 12 months(From time of enrollment until end of treatment at 12 months)
- Change from baseline in vascular endothelial function at 12 months(From enrollment to the end of treatment at 12 months)
- Change from baseline in arterial stiffness at 12 months(From enrollment until end of treatment at 12 months)
- Change from baseline in diabetic retinopathy at 12 months(From enrollment until to the end of treatment at 12 months)