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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF [ Time Frame: 6 months ]

Original Primary Outcome: Determine the effect of low carbohydrate/low fructose diet versus standard weight- reduction diet on hepatic triglyceride content measured by Magnetic resonance (MR) PDFF [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Metabolic biomarkers [ Time Frame: 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
  • PNPLA3 genotype [ Time Frame: 6 months ]
  • Novel free breathing hepatic MR PDFF protocol [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Compare changes in metabolic biomarkers [ Time Frame: 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
  • Correlate hepatic MR PDFF response to intervention and control diets with PNPLA3 genotype [ Time Frame: 6 months ]
  • Validate a novel free breathing hepatic MR PDFF protocol compared to the current protocol that requires a 20-second breath-hold [ Time Frame: 6 months ]


Information By: University of Wisconsin, Madison

Dates:
Date Received: April 14, 2014
Date Started: April 2014
Date Completion: June 2017
Last Updated: September 9, 2016
Last Verified: September 2016