Clinical trial NCT02589327: Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Official title: Effects of Exercise on Cardiac Fat in Women With Obesity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Detailed description: Excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. More effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. Despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. The aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Eligibility criteria: Inclusion Criteria:

* BMI 30-39.99
* White/Caucasian

Exclusion Criteria:

* Known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
* Pregnant females.
* Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
* Participants that exercise more than three times per week or strength train more than twice per week.
* Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
* Cigarette smoking (current or those who quit within the previous 6 months
* Hypertension
* Diabetics
* MRI exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. Some forms of metal are acceptable (e.g., dental fillings after 1970). Tattoos are generally not exclusionary, unless they have been inked with metallic dyes. All metal must be removed from your body. All female subjects, prior to scanning, are required to complete a pregnancy test. Must NOT be claustrophobic or have a history of claustrophobia

Primary outcomes:
measure: Changes in Cardiac fat volumes
timeFrame: 2 assessment points: at baseline and week 4
Secondary outcomes:
measure: Changes in Vascular function
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Cardiorespiratory Function
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Muscular Strength
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Body Composition
timeFrame: 2 assessment points: at baseline and week 4
measure: Changes in Diet
timeFrame: 5 assessment points: baseline, week 1, 2, 3, and 4
measure: Changes in Spontaneous Physical Activity
timeFrame: Baseline and week 4
measure: Changes in Oxidative stress markers
timeFrame: 5 assessment points: pre-post during session 1, pre-post during session 9, and pre week 4.
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Kinesiology and Sport Management
state: Texas
Study officials:
affiliation: Texas Tech University
name: Maria Fernandez del Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References: