Non-alcoholic Fatty Liver Disease Clinical Trial
— NAFLDOfficial title:
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
NCT number | NCT02116192 |
Other study ID # | K12HD055894 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | October 2017 |
Verified date | October 2018 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | October 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Research Park Clinic | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF | 6 months | ||
Secondary | Metabolic biomarkers | 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 | 6 months | |
Secondary | PNPLA3 genotype | 6 months | ||
Secondary | Novel free breathing hepatic MR PDFF protocol | 6 months |
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