NCT00703482已完成2 期
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 3
- 主要终点
- Evolution of the E'/E septal ratio
研究概览
简要总结
The purpose of this study was to study the effect of different combinations of fenofibrate and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes
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
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged from 40 to 79 years
- •Patients with pre-existing T2DM
- •HbA1C <9%
- •Written informed consent
排除标准
- •unable to comply with the protocol, Likely to leave the trial before completion
- •having participated in an another trial 3à days before V1
- •Pregnant or childbearing potential not using birth control method
- •Type 1 diabetic patients, T2Dm insulin therapy
- •Patients with one of the following pathology:
- •with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase
- •with symptomatic gall-bladder disease or/and renal insufficiency
- •with abnormal thyroid function
- •with proliferative retinopathy
- •with recent cardiovascular event, uncontrolled hypertension
- •with known chronic alcohol intake
- •with other severe pathology
- •with TC>= 7.0 mmol/L and/or TG>= 4mmol/L at V1
- •Patients treated with Warfarin
- •Patients with specific ECG dysfunction
研究组 & 干预措施
1
Placebo Comparator
干预措施: Fenofibrate/CoQ10 (Drug)
2
Active Comparator
干预措施: Fenofibrate/CoQ10 (Drug)
3
Active Comparator
干预措施: Fenofibrate/CoQ10 (Drug)
4
Experimental
干预措施: Fenofibrate/CoQ10 (Drug)
5
Experimental
干预措施: Fenofibrate/CoQ10 (Drug)
6
Experimental
干预措施: Fenofibrate/CoQ10 (Drug)
7
Experimental
干预措施: Fenofibrate/CoQ10 (Drug)
结局指标
主要结局
Evolution of the E'/E septal ratio
时间窗: End of study (V6)
次要结局
- Severity of the LVDD(End of study (V6))
- Evolution of the Left atrium and right atrium volumes(End of study (V6))
- Evolution of the Left and right sizes(End of study (V6))
- Evolution of the LVEDD and LVESD(End of study (V6))
- Evolution of the LVEDV and LVESV(End of study (V6))
- Evolution of the LV mass(End of study (V6))
- Evolution of the LV ejection fraction(End of study (V6))
- Evolution of the IVRT(End of study (V6))
- Evolution of the tissue Doppler E'/A' ratio(End of study (V6))
- Evolution of the PV doppler parameters(End of study (V6))
研究者
研究点 (3)
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