Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Cardiovascular Fitness
研究概览
简要总结
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
详细描述
The study investigators want to learn more about the effect of a type of exercise on non-alcoholic fatty liver disease (NAFLD), and on markers of health (for example, liver, heart, and overall health) and how the body uses energy in teenagers. The exercise we are studying is called high-intensity interval training, or HIIT. Some participants in this study will receive a 4-week exercise program, and the others will not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial Enrollment
- •Ages 13-18 years (inclusive) for both sexes
- •Any ethnic/racial background
- •English speaking competence
- •Teenagers ages 13-15 weighing more than 145 pounds OR teenagers ages 16-18 weighing more than 170 pounds
- •Low risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
- •Late stages of puberty (i.e., Tanner stage IV or V) based on Tanner Staging.
- •Inclusion Criteria: Control or Exercise Group
- •Presence of Non-Alcoholic Fatty Liver Disease (NAFLD) as determined by FibroScan Controlled Attenuated Parameter (CAP) score
- •Confirmed lack of diabetes as determined by Oral Glucose Tolerance Test (OGTT)
- •Confirmed eligibility per medical history
- •Exclusion criteria:
- •Pre-pubertal or early stages of puberty
- •Pregnancy
- •Confirmed lack of NAFLD in the past 6 months via biopsy or MRI
- •Presence of an implantable medical device or metal objects in the body (a contraindication for FibroScan and/or MRI)
- •High-risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
- •Unable to cooperate with study procedures and tests including genetic or physical conditions impacting mobility over the past year
- •Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, type 2 diabetes, neurologic (e.g., epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (Cushing's, growth hormone deficiency), hepatic (other than NAFLD), autoimmune, cardiac and renal disorders
- •Current history of poorly-controlled asthma.
- •Taking any of the following medications that can affect study outcome at the time of enrollment: insulin, metformin, or any other anti-diabetics, antipsychotics, oral steroids, and anabolic drugs (growth hormone replacement therapy, testosterone, and oxandrolone).
- •Adolescents who have a history of claustrophobia.
- •Adolescents who need sedation in order to complete MRI.
- •Adolescents determined ineligible by the study investigator or delegated staff.
排除标准
- 未提供
结局指标
主要结局
Cardiovascular Fitness
时间窗: 4 weeks
Cardiovascular fitness will be assessed via "peak oxygen uptake" (VO2 max). VO2 max is expressed as milliliters per body weight per minute in kilograms of lean body mass (mL/min/kg per LBM). There is no established normative data for VO2 max in pediatric population; however, higher values indicate better cardiovascular fitness.
HOMA-IR
时间窗: 4 weeks
The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated using the fasting glucose and insulin levels. Higher HOMA-IR values indicate greater insulin resistance. HOMA-IR is calculated as "fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5". HOMA-IR has an arbitrary unit. Higher numbers suggest worse outcomes.
Intrahepatic Triglyceride (IHTG)
时间窗: 4 weeks
Intrahepatic triglyceride (IHTG) percent (%) will be measured via Magnetic Resonance Imaging (MRI). IHTG percent can theoretically range between 0 and 100. By definition, an individual has Non-Alcoholic Fatty Liver Disease (NAFLD) when the IHTG percent is at or above 5 percent.
次要结局
- FibroScan - Controlled Attenuated Parameter(4 weeks)
- FibroScan - Transient Elastogram(4 weeks)
- Body Composition - Total Body Fat(4 weeks)
- Alanine Aminotransferase(4 weeks)