Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents

University of Wisconsin, Madison1 site in 1 country28 target enrollmentApril 2014

ConditionsNon-alcoholic Fatty Liver Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: University of Wisconsin, Madison
Enrollment: 28
Locations: 1
Primary Endpoint: Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.

Detailed Description

This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI \>95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

October 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•11-17 years of age
•BMI \>95%tile for age and sex
•Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic
•Parent willing to participate in study

Exclusion Criteria

•History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.