EUCTR2015-004875-61-FR进行中（未招募）1 期
Influence of apelin on insulin sensitivity in type 2 diabetic volunteers - APELINS 2
CHU TOULOUSE0 个研究点开始时间: 2015年12月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patient aged 40-65 years.
- •Type 2 diabetes
- •Diabetes treated with oral antidiabetic agents only
- •BMI between 27 and 33 Kg / cm².
- •HbA1c <8.5%
- •Non-pathological ECG
- •Resting heart rate of between 50 and 80 beats per minute
- •Complete Blood Count (CBC) without clinically significant abnormalities in terms of the investigator.
- •Liver function tests without clinically significant abnormalities in terms of the investigator.
- •Renal function tests without clinically significant abnormalities in terms of the investigator .
- •Serum electrolytes without clinically significant abnormalities in terms of the investigator.
- •Good peripheral venous system (forearm and back of the hand)
- •Acceptance to participate in the establishment of a serum bank
- •Ability to sign an informed consent.
- •Affiliation to a social security scheme or equivalent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients experiencing secondary cardiovascular prevention.
- •Diabetes treated by insulin or GLP-1 in the 6 months prior to inclusion
- •Risk factor, treatment or ECG as recommended ICH E14 Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs:
- •- Repeated measurement of a QTc interval> 450 ms
- •- Torsade de pointes risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome
- •Personal history of cancer.
- •Positive HIV serology.
- •Hepatitis B serology positive.
- •Hepatitis C serology positive.
- •Cognitive impairment or mental illness (at the discretion of the investigator)
- •Excessive alcohol chronic use (consumption> 30g / day or 210g / week)
- •Subject having a systolic blood pressure greater than the rest to 140 mm Hg and 90 mm Hg diastolic
- •Smoking> 10 cig / day and can not be interrupted during 24 hours
- •About participating in another research protocol or exclusion period from another protocol
- •Nobody in safeguarding justice, guardianship
研究者
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