Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism

Left Ventricular Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01199211
• Other study ID #: CTSI-6212
• Status: Terminated
• Start date: February 2011
• Est. completion date: October 2017

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 187
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
United States	CTSI - University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid Metabolism		Baseline, In-Training, Post-training (at least 6 weeks after the race)
Secondary	Heart architecture and function		Baseline, In-training, Post-training