NCT01429818已完成4 期
Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients. Positron Emission Tomography Assessment(PET)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- EDVI
研究概览
简要总结
The Purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ED) in asymptomatic patients with type 2 diabetes mellitus (DM) using 13N-ammonia-positron emission tomography (PET).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •At least 18 years old
- •Type 2 diabetes mellitus diagnosis
- •Signed Informed Consent
排除标准
- •History of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases
- •Pregnancy or lactation
- •History of abuse and/or substance dependence within 6 months preceding the survey.
- •History of glimepiride or metformin allergy
研究组 & 干预措施
Glimepiride/metformin
Experimental
干预措施: Glimepiride/metformin (Drug)
Metformin
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
EDVI
时间窗: 8 weeks
endothelial-dependent vasodilation index
MFR
时间窗: 8 weeks
myocardial flow reserve
%ΔMBF
时间窗: 8 weeks
percentage of the change between rest and CPT
次要结局
- Fasting glucose(8 weeks)
- Glycated hemoglobin(8 weeks)
- Adverse effects(8 weeks)
研究者
研究点 (1)
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