A Randomised Placebo-controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo
研究概览
简要总结
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.
Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.
Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
- •Aged 35-75 years
- •Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
- •All patients will be on statin
排除标准
- •Pregnancy and/or lactation at screening
- •Premenopausal woman not on contraception
- •Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose [FPG] < 7.0 mmol/L at screening18)
- •Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
- •Patients with Acute Coronary Syndrome within the last 3 months
- •Clinically unstable heart failure
- •Uncontrolled angina
- •Contraindications to metformin
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in progression of carotid intima-media thickness (measured in millimetres) between groups treated with metformin and placebo
时间窗: 1.5 years
次要结局
- Correlation of HbA1C, t-PA, CRP, IL-6, HOMA-IR and ICAM-1 with change in carotid IMT in metformin- and placebo-treated groups will be evaluated.(1.5 years)
- Difference in progression of carotid total plaque area (measured in square millimetres) between groups treated with metformin and placebo(1.5 years)
- Difference in progression of carotid total plaque volume (measured in cubic millimetres) between groups treated with metformin and placebo(1.5 years)
研究者
Professor Naveed Sattar
Professor of Metabolic Medicine
University of Glasgow