EUCTR2011-000300-18-DK进行中（未招募）1 期
Reducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes
HS Greater Glasgow and Clyde Board0 个研究点目标入组 120 人开始时间: 2012年5月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- All
入选标准
- •Type 1 diabetes; age = 40 years; 7.0 = HbA1c < 10.0% (53-86 mmol/mol)
- •AND three or more of the following ten CVD risk factors:
- •(i) BMI = 27 kg/m2
- •(ii) current HbA1c > 8.0% (64 mmol/mol)
- •(iii) known CVD/ peripheral vascular disease
- •(iv) current smoker
- •(v) eGFR < 90 ml/ min/ 1.73 m2
- •(vi) micro- (or macro-) albuminuria [according to local assays and reference ranges]
- •(vii) hypertension (BP¬=140/ 90 mmHg; or established on antihypertensive treatment)
- •(viii) dyslipidaemia [total cholesterol=5.0 mmol/L (200 mg/dL); or HDL cholesterol<1.20 mmol/L (46 mg/dL) [men] HDL cholesterol<1.30 mmol/L (50 mg/dL) [women]; or fasting triglycerides=1.7 mmol/L (150 mg/dL); or established on lipid-lowering treatment
- •(ix) strong family history of CVD (at least one parent or sibling with myocardial infarction or stroke aged < 60 years)
- •(x) duration of diabetes > 20 years.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •(i) eGFR < 45 ml/ min/ 1.73m2
- •(ii) woman of childbearing age not on effective contraception – see Appendix 4
- •(iii) pregnancy and/or lactation
- •(iv) Acute Coronary Syndrome within the last 3 months
- •(v) NYHA stage 3 or 4 heart failure
- •(vi) uncontrolled angina
- •(vi) suspected hypoglycaemia unawareness
- •(vii) impaired cognitive function/ unable to give informed consent
- •(viii) previous carotid surgery/ inability to capture adequte carotid images
- •(ix) gastroparesis
- •(x) history of lactic acidosis
- •(xi) other contraindications to metformin
- •-hepatic impairment
- •-known hypersensitivity to metformin
- •-acute illness (dehydration, severe infection, shock,
- •acute cardiac failure)
- •-suspected tissue hypoxia
- •(xii) Any coexistent life threatening condition including prior diagnosis of cancer within two years
- •(xii) history of alcohol problem or drug abuse
研究者
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