Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism
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ClinicalTrials.gov Identifier: NCT01199211 |
Recruitment Status :
Terminated
(IRB approval expired)
First Posted : September 10, 2010
Last Update Posted : July 31, 2020
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Condition or disease | Intervention/treatment |
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Left Ventricular Hypertrophy | Other: Exercise training, women, marathon |
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.
Study Type : | Observational |
Actual Enrollment : | 187 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism in Healthy Female Volunteers Training for a Marathon |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | October 2017 |
Actual Study Completion Date : | October 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Exercise training, women, marathon.
Other: prospective study with no intervention
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Other: Exercise training, women, marathon
Prospective study with no intervention in women who have volunteered to run a full marathon or a half-marathon. Each subject will serve as own control. Each subject will be studies at 3 stages: baseline, after at least 12 weeks of training for the marathon (we will not provide training), 6 weeks after running the marathon. |
- Lipid Metabolism [ Time Frame: Baseline, In-Training, Post-training (at least 6 weeks after the race) ]
- Heart architecture and function [ Time Frame: Baseline, In-training, Post-training ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Diabetes
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199211
United States, California | |
CTSI - University of California San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Eveline Stock, MD | University of California, San Francisco | |
Principal Investigator: | Nelson Schiller, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01199211 |
Other Study ID Numbers: |
CTSI-6212 |
First Posted: | September 10, 2010 Key Record Dates |
Last Update Posted: | July 31, 2020 |
Last Verified: | July 2020 |
hypertrophy, exercise, HDL, lipids, cholesterol |
Hypertrophy, Left Ventricular Hypertrophy Pathological Conditions, Anatomical |
Cardiomegaly Heart Diseases Cardiovascular Diseases |