Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Albuminuria
研究概览
简要总结
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.
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
- •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
- •Blood pressure <140/90 mm Hg prior to randomization
- •Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
- •BMI < 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients).
- •Stable anti-hypertensive regimen for at least one month prior to randomization
- •Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization
- •Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
- •Able to provide consent
排除标准
- •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
- •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 (higher risk of neuropsychiatric reaction)
- •Penicillin allergy
- •Iodine allergy
- •Shellfish allergy
- •Current use of phenobarbital, rifampin or carbamazepine
研究组 & 干预措施
Montelukast
One 10mg capsule daily
干预措施: Montelukast (Drug)
Placebo
One capsule daily
干预措施: Placebo (Other)
结局指标
主要结局
Change in Albuminuria
时间窗: Baseline, 6 months
Change in albuminuria from baseline to 6 months
次要结局
- Change in Large Elastic Artery Stiffness(Baseline, 6 months)
- Change in Brachial artery flow mediated dilation (FMD)(Baseline, 6 months)