Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children

Overweight and Obesity Clinical Trial

— SMART  

Official title:

Exercise and Overweight Children's Cognition (Supplement)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383485
• Other study ID #: R01HL087923-02S1
• Secondary ID: R01HL087923-02S1
• Status: Completed
• Phase: N/A
• First received: March 4, 2015
• Last updated: March 4, 2015
• Start date: May 2008
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Exercise
Heart rate monitors worn by each child at each session
• After-school program
Supervised recreational program with token economy

Locations

Country	Name	City	State
United States	Georgia Prevention Institute	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Regents University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Liver Fat	Change in the proportion of liver fat via MRI	Baseline, 8 Months	No
Primary	Change in Arterial Stiffness	Change in carotid-femoral pulse wave velocity	Baseline, 8 Months	No
Secondary	Change in Liver Fibrosis	Change in Fibroscan transient elastography measure	Baseline, 8 Months	No
Secondary	Change in Liver Inflammation	Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein	Baseline, 8 Months	No
Secondary	Change in Quality of Life	Change in PedsQL questionnaire responses	Baseline, 8 Months	No
Secondary	Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices	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).	Baseline	No

External Links

•   NIH Reporter page for the grant supplement