Insulin Resistance Clinical Trial
Official title:
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
Verified date | July 2023 |
Source | Arkansas Children's Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
Status | Completed |
Enrollment | 40 |
Est. completion date | November 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility | Inclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Nutrition Center | Little Rock | Arkansas |
United States | Arkansas Children's Pediatric Clinical Research Unit | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute | National Institute of General Medical Sciences (NIGMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrahepatic Triglyceride (IHTG) | 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. | 4 weeks | |
Primary | Cardiovascular Fitness | 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. | 4 weeks | |
Primary | HOMA-IR | 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. | 4 weeks | |
Secondary | Alanine Aminotransferase | Serum alanine aminotransferase (ALT) level will be measured. ALT level is reported in international unit/liter or IU/L. Higher ALT levels suggest presence of hepatocellular damage. | 4 weeks | |
Secondary | FibroScan - Controlled Attenuated Parameter | Controlled Attenuated Parameter (CAP) score will be measured using FibroScan. CAP score is reported in decibel/meter (dB/m) and ranges between 100-400. A score of 241 dB/m or greater is consistent with non-alcoholic fatty liver disease. | 4 weeks | |
Secondary | FibroScan - Transient Elastogram | Transient Elastogram (TE) score will be measured using FibroScan. TE score is reported in kilopascals (kPa) and ranges between 0-75. A score of 8.5 kPa or greater is consistent with fibrotic liver disease. | 4 weeks | |
Secondary | Body Composition - Total Body Fat | Body composition will be measured using Dual X-Ray Absorptiometry (DXA) scan. Normative data for total body fat is not established; however, larger total body fat percentage (percentage of total body weight) is linked to higher intrahepatic triglyceride content and insulin resistant state. | 4 weeks |
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