NCT01342744Unknown4 期
Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cardiovascular risk factors
研究概览
简要总结
The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute
排除标准
- •Previous cardiovascular diseases
- •Contraindicated to metformin: serum creatinine >1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis
- •Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment
- •Fasting blood sugar ≥ 200 mg/dL or HbA1c >8%
- •Serum triglyceride ≥500 mg/dL
- •Abnormal EKG
研究组 & 干预措施
Metformin
Experimental
Metformin (850mg) 1 tab oral twice a day
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
Placebo 1 tab oral twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Cardiovascular risk factors
时间窗: 6 months
To compare the cardiovascular risk factors, including blood pressue, fasting blood sugar (FBS), Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR), 75-g oral glucose tolerance test (75-g OGTT), lipid profile, high sensitivity C-reactive protein(hs-CRP), neck circumference and waist circumference, between metformin and plcebo at 6 months
次要结局
- 10-year risk of coronary heart disease(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Addition of metformin to growth hormone for short children born small for gestational ageISRCTN19548431Hospital Sant Joan de Deu (Spain)64
已完成
2 期
Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and DiabetesInsulin ResistanceChronic Heart FailureNCT01690091Institute for Clinical and Experimental Medicine40
已完成
2 期
The Effects of Metformin on Blood Vessel Structure and FunctionObesityHypertensionHypercholesterolemiaHyperglycemiaNCT00105066National Institute on Aging (NIA)77
进行中（未招募）
1 期
The effect of metformin on weight and cardiovascular risk markers in abdomenally obese subjects with impaired fasting glucose previously treated for 12 months with either rimonabant or placebo - Use of Metformin following weight loss and improvement in CV riskImpaired fasting glucoseMedDRA version: 9.1Level: LLTClassification code 10056997Term: Impaired fasting glucoseEUCTR2008-004497-40-GBHull and East Yorkshire Hospitals NHS Trust
已完成
2 期
Evaluation of the effect of metformin in STEMI patients treated with thrombolytic therapyIRCT20111206008307N34Tabriz University of Medical Sciences80