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临床试验/NCT01037660
NCT01037660已完成早期 1 期

Effects of Lipemia and Metformin on Endothelial Function

Boston University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
139
试验地点
1
主要终点
Brachial artery flow-mediated dilation

研究概览

简要总结

Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood). A similar response is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition). The present study is designed to help us understand the effects of a fat load on blood vessel function. We will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of blood vessels during a fat load. This study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • Pregnancy (defined as positive urine pregnancy test)
  • Diabetes Mellitus (Clinical history or random blood glucose>140 mg/dl)
  • Hypertension (Clinical history or SBP>140 or DBP>90 mmHg)
  • History of adverse reaction to metformin
  • Abnormal renal function (Serum creatinine>1.4 mg/dl)
  • Abnormal liver function (AST or ALT greater than two times the upper limit of normal)
  • Administration of iodinated contrast within 7 days
  • History of congestive heart failure
  • Abnormal clotting parameters (INR>1.5 or PTT>40 sec)
  • Anemia (HCT<30%)
  • Allergy to soy or egg
  • Allergy to heparin
  • The potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing

研究组 & 干预措施

Metformin

Experimental

Metformin

干预措施: Metformin (Drug)

结局指标

主要结局

Brachial artery flow-mediated dilation

时间窗: 6 hours

次要结局

  • blood lipid levels(6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naomi M Hamburg

PI

Boston University

研究点 (1)

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