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

NCT02116192 | Completed

• 1 other identifier: K12HD055894
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic Fatty Liver Disease; Adolescent

Outcome Measures

Primary Outcomes (1)

• Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF

  6 months

Secondary Outcomes (3)

• Metabolic biomarkers

  6 months

• PNPLA3 genotype

  6 months

• Novel free breathing hepatic MR PDFF protocol

  6 months

Study Arms (2)

General Healthy Diet

ACTIVE COMPARATOR

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)

Behavioral: General Healthy Diet

Low-fructose, reduced carbohydrate diet

EXPERIMENTAL

Intervention: Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat) ● Aim for less than 25g fructose daily.

Behavioral: Experimental: Low-fructose, reduced carbohydrate diet

Interventions

Experimental: Low-fructose, reduced carbohydrate diet BEHAVIORAL

Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat) ● Aim for less than 25g fructose daily.

Low-fructose, reduced carbohydrate diet

General Healthy Diet BEHAVIORAL

Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat

General Healthy Diet

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Research Park Clinic

Madison, Wisconsin, 53711, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jennifer Rehm, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (1)