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

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Behavioral: General Healthy Diet

• Registration Number: NCT02116192
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-16
• Primary Completion: 2016-07
• Study Completion: 2017-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Healthy Diet	General Healthy Diet	Control: General Healthy Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat)

Primary Outcome Measures

Name	Time	Method
Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF	6 months

Secondary Outcome Measures

Name	Time	Method
Novel free breathing hepatic MR PDFF protocol	6 months
PNPLA3 genotype	6 months
Metabolic biomarkers	6 months	Including waist circumference (WC), blood pressure (BP), insulin resistance measured by homeostasis model assessment (HOMA-IR), lipids, ALT, androgens, and visceral and subcutaneous adiposity (by MR PDFF), and cardiovascular fitness (sub-maxVO2 test), in low carbohydrate/low fructose and standard weight-reduction diet groups

Trial Locations

Locations (1)

Research Park Clinic; 🇺🇸 Madison, Wisconsin, United States