Mechanism of Hyperglycemia and Neuroprotection Effect of Pioglitazone in Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
Pioglitzone, an oral anti-diabetic drug which can reduce insulin resistance and decrease inflammation. It has been proven to be an effective neuroprotective agent in animal model of ischemic stroke. In this study, the investigators will conduct a phase II clinical trial (double-blind, randomized placebo controlled study) to survey the neuroprotection effect of pioglitazone in stroke patients with hyperglycemia. A total of 152 acute ischemic stroke patients with hyperglycemic will receive insulin or sulfonyurea for blood sugar control, and will be randomly randomized into intervention (Pioglitazone 30mg once a day p.o,) and control group (placebo). The investigators expect to prove the neuroprotective efficacy of Pioglitazone in acute stroke with hyperglycemia and identify the biomarkers associated with good neurological outcome in patients with Pioglitazone treatment from the investigators clinical trial.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke onset within 48 hours
- •Age≧20 years
- •Stroke severity with at least one point for limb weakness in National Institutes of Health Stroke Scale (NIHSS).
- •The patients with no known history of diabetes with admission serum glucose ≧130 mg/dl.
排除标准
- •The patients who have history of urinary bladder cancer or hematuira.
- •The patients who have history of congestive heart failure or myocardial infarction.
- •The patients who have known history of using pioglitazone before the onset of stroke.
- •The patients who have mRS≧3 before stroke onset.
研究组 & 干预措施
Pioglitazone
干预措施: Pioglitazone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: Day 90 after stroke
次要结局
- Barthel's Index(Day 90 after stroke)
- National Institute of Health Stroke Scale (NIHSS)(Day 90 after stroke)