Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-03-29 @ 5:56 AM
Study NCT ID:
NCT02116192
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2014-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFLD
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: