Clinical trial NCT01199211: Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism
Official title: Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism in Healthy Female Volunteers Training for a Marathon
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Left Ventricular Hypertrophy
Keywords: hypertrophy, exercise, HDL, lipids, cholesterol
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample. Participants will be recruited by invitation to volunteer in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid Metabolism
timeFrame: Baseline, In-Training, Post-training (at least 6 weeks after the race)
Secondary outcomes:
measure: Heart architecture and function
timeFrame: Baseline, In-training, Post-training
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CTSI - University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eveline Stock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Nelson Schiller, MD
role: PRINCIPAL_INVESTIGATOR
References: