Non-alcoholic Fatty Liver Disease, Overweight and Obesity
Conditions
Keywords
arterial stiffness
Brief summary
Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program. Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.
Detailed description
This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children (SMART study, R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.
Interventions
BEHAVIORALExercise
Heart rate monitors worn by each child at each session
BEHAVIORALAfter-school program
Supervised recreational program with token economy
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* 8-11 years of age * Overweight or obese (BMI-for-age \>= 85th percentile) * Able to participate in exercise testing and intervention * Participating in the SMART Study
Exclusion criteria
* Medical condition or medications that would interfere with measurements * Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week * T-score \> 75 on the BRIEF Behavior Regulation scale to avoid program disruption * Unable to complete magnetic resonance imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fat | Baseline, 8 Months | Change in the proportion of liver fat via MRI |
| Change in Arterial Stiffness | Baseline, 8 Months | Change in carotid-femoral pulse wave velocity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fibrosis | Baseline, 8 Months | Change in Fibroscan transient elastography measure |
| Change in Liver Inflammation | Baseline, 8 Months | Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein |
| Change in Quality of Life | Baseline, 8 Months | Change in PedsQL questionnaire responses |
| Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices | Baseline | At baseline, the proportion of liver fat (ascertained by MRI) will be closely related to indices of liver fibrosis (as detected by transient elastography) and inflammation (ratio of aspartate aminotransferase to alanine aminotransferase, AST/ALT; C-reactive protein, CRP), and to arterial stiffness and other indices of cardiovascular risk (body fat (DXA), visceral fat (MRI), aerobic fitness, insulin resistance, adiponectin, dyslipidemia). |
Countries
United States
Outcome results
None listed