Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism

NCT01199211 | Terminated DMC

• 1 other identifier: CTSI-6212
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Hypertrophy

Keywords

hypertrophy, exercise, HDL, lipids, cholesterol

Outcome Measures

Primary Outcomes (1)

• Lipid Metabolism

  Baseline, In-Training, Post-training (at least 6 weeks after the race)

Secondary Outcomes (1)

• Heart architecture and function

  Baseline, In-training, Post-training

Study Arms (1)

Exercise training, women, marathon.

Other: prospective study with no intervention

Other: Exercise training, women, marathon

Interventions

Exercise training, women, marathon OTHER

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.

Exercise training, women, marathon.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample. Participants will be recruited by invitation to volunteer in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

CTSI - University of California San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Hypertrophy; Motor Activity

Interventions

Exercise; Marathon Running

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Running; Locomotion

Study Officials

• Eveline Stock, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nelson Schiller, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: February 1, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

US (1)