NCT00482976已完成2 期
The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
研究概览
简要总结
To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.
详细描述
32mg Ruboxistaurin; 4 week cross-over treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
- •HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
- •Blood pressure less than 160/100 mmHg
- •Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl
排除标准
- •Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit
- •History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
- •Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
- •TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
- •ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.
结局指标
主要结局
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
时间窗: 4 weeks
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
时间窗: 4 weeks
Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes.
时间窗: 4 weeks
次要结局
- Safety of ruboxistaurin(4 weeks)
研究者
研究点 (1)
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