Status:
COMPLETED
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Lead Sponsor:
Emory University
Conditions:
Non-alcoholic Fatty-liver Disease
Eligibility:
All Genders
11-18 years
Phase:
NA
Brief Summary
Primary Objectives: 1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic s...
Detailed Description
Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking...
Eligibility Criteria
Inclusion
- BMI \> 85th %tile
- Self identified as Hispanic
- Age 11-18 years
- Baseline hepatic fat fraction \>8%
- Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).
Exclusion
- Currently attempting weight gain or weight loss
- Cirrhosis visible on baseline MRI
- Renal insufficiency found on screening labs (creatinine \> 2)
- Recent acute illness within past 4 weeks (defined by fever \> 100.4ºF)
- Pregnancy
- Chronic illness requiring medication including diabetes
- Fasting glucose \>120 on screening labs
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01188083
Start Date
June 1 2009
End Date
November 1 2012
Last Update
November 21 2013
Active Locations (1)
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1
Emory Children's Center
Atlanta, Georgia, United States, 30322