The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in Arterial Stiffness Compared to Baseline
研究概览
简要总结
The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).
详细描述
Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:
- Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
- Elevated triglycerides (>150 mg/dl)
- Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
- Elevated blood pressure (>130/85) or treatment for high blood pressure
- Elevated fasting blood sugar (>100 mg/dl)
Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function.
This study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams.
Taking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:
- •Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
- •Elevated triglycerides (>150 mg/dl)
- •Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
- •Elevated blood pressure (>130/85) or treatment for high blood pressure
- •Elevated fasting blood sugar (>100 mg/dl)
排除标准
- •Diabetes treated with medication
- •Blood pressure >160/100 mmHg
- •Clinical Congestive Heart Failure
- •Anemia with hematocrit <32%
- •Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy
- •Major surgery planned within the next six months
- •A recent, unexplained weight loss of >10% of body weight in the past 6 months
- •A known allergy or hypersensitivity to Metformin
- •History of hepatitis or cirrhosis
- •History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women)
- •Pregnancy or the absence of an effective method of contraception
- •Illicit drug or alcohol abuse
- •Cancer requiring treatment currently or recently completed treatment in the last 2 months
研究组 & 干预措施
Placebo
placebo
干预措施: Placebo (Drug)
Metformin
Metformin 850 mg twice daily
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Arterial Stiffness Compared to Baseline
时间窗: Baseline and 4.5 months
Change in Flow Mediated Dilation (FMD)
时间窗: Baseline and 4.5 months
to evaluate improvement in endothelial function
次要结局
未报告次要终点