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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date September 9, 2010
First Posted Date September 10, 2010
Last Update Posted Date July 31, 2020
Study Start Date February 2011
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2013)
Lipid Metabolism [ Time Frame: Baseline, In-Training, Post-training (at least 6 weeks after the race) ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2013)
Heart architecture and function [ Time Frame: Baseline, In-training, Post-training ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Community sample. Participants will be recruited by invitation to volunteer in the study.
Condition 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.
Study Groups/Cohorts Exercise training, women, marathon.
Other: prospective study with no intervention
Intervention: Other: Exercise training, women, marathon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: July 29, 2020)
187
Original Estimated Enrollment
 (submitted: September 9, 2010)
50
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01199211
Other Study ID Numbers CTSI-6212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Eveline Stock, MD University of California, San Francisco
Principal Investigator: Nelson Schiller, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2020