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临床试验/NCT01199211
NCT01199211终止不适用

Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism in Healthy Female Volunteers Training for a Marathon

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
187
试验地点
1
主要终点
Lipid Metabolism

研究概览

简要总结

Prospective study on the structural and functional changes in the heart of adult women assessed by echocardiogram and in lipid metabolism that occur in response to physical training. Using echocardiogram we will characterize the early determinants of "athletic remodeling". We will also assess the effect of intense physical training on lipid metabolism, focus on HDL subspecies and function.

详细描述

Left ventricular hypertrophy, defined as an increase in the mass of the left ventricle may occur as a physiologic response to exercise (athletic remodeling aka "athletic heart"), but is most frequently encountered as a pathological manifestation of cardiovascular disease. The early determinants of athletic remodeling in the general population are largely unknown. In order to longitudinally explore the early determinants of athletic remodeling, we will recruit from the community, physically untrained women who have volunteered to run a marathon. We will prospectively assess left ventricular mass and function by echocardiogram during three consecutive stages/visits:

  • Baseline: prior to starting intense physical training
  • Trained: at the end of at least 12 week training period, prior to running the marathon.
  • Post-marathon: 6 weeks after running the marathon.

In addition, exercise impacts lipid metabolism and short-term exercise is known to increase HDL levels in plasma. Human HDL is structurally heterogeneous, comprising at least sixteen discrete species. It has multiple functions, pertinent to cardiovascular medicine such as the ability to accept effluxed cholesterol from the artery wall, culminating in sterol uptake in the liver. This "reverse cholesterol transport pathway" is thought to prevent the accumulation of cholesterol in the artery wall. We will assess the clinical and genetic determinants of the HDL response to physical exercise.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Healthy adult men or women, aged 18 years or older
  • Voluntarily signed up for a sport event or to run a marathon or a half marathon for the first time
  • Normal to mildly elevated blood pressure (systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg)
  • Hormone replacement therapy and birth control pills are allowed, provided they have been on a stable dose for more than 3 months and no change in dose is planned for the duration of the study
  • Capable and willing to provide written, informed consent for the study

排除标准

  • History of cardiovascular disease within the past year (cardiomyopathy, heart failure, ischemic heart disease, stroke, TIA, peripheral vascular disease)
  • Change in body weight more than 10% over the past year
  • History of significant medical conditions, including respiratory, gastrointestinal, neuromuscular, neurological or musculoskeletal problems interfering with exercise.
  • Autoimmune or collagen vascular diseases, chronic anemia,
  • Malignancies in the past 5 years, with the exception of treated skin or breast cancer that did not require treatment with chemotherapy.
  • Pregnancy or recent delivery: delivery date less than 3 months prior to enrollment
  • Lipid lowering medications (statins, niacin, resins) are allowed, provided dose has not changed for 3 months prior to enrollment and is not anticipated to change during the study
  • Fish Oil supplements are allowed, provided dose has been unchanged for 3 months prior to enrollment and no change in dose is planned for the duration of the study.

结局指标

主要结局

Lipid Metabolism

时间窗: Baseline, In-Training, Post-training (at least 6 weeks after the race)

次要结局

  • Heart architecture and function(Baseline, In-training, Post-training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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