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Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01199211
First received: September 9, 2010
Last updated: May 6, 2015
Last verified: May 2015
History of Changes
  Purpose
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.

Condition Intervention
Left Ventricular Hypertrophy
 Other: Exercise training, women, marathon

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism in Healthy Female Volunteers Training for a Marathon

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Lipid Metabolism [ Time Frame: Baseline, In-Training, Post-training (at least 6 weeks after the race) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart architecture and function [ Time Frame: Baseline, In-training, Post-training ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Plasma

Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exercise training, women, marathon.
Other: prospective study with no 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.

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
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample. Participants will be recruited by invitation to volunteer in the study.
Criteria

Inclusion Criteria:

  • Healthy premenopausal adult women, aged 18 years or older
  • Voluntarily signed up 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:

  • Post menopausal (last period more than one year ago)
  • History of cardiovascular disease (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)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199211

Locations
United States, California
CTSI - University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Elyse Foster, MD University of California, San Francisco
Principal Investigator: John Kane, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01199211     History of Changes
Other Study ID Numbers: CTSI-6212 
Study First Received: September 9, 2010
Last Updated: May 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
hypertrophy, exercise, HDL, lipids, cholesterol

Additional relevant MeSH terms:
Hypertrophy
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
 Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016