Expired Study
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Atlanta, Georgia 30322


Purpose:

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 steatosis. 2. To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal. 3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress. Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.


Study summary:

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 any chronic medication with no recent acute illnesses. Definitions: - BMI >95th %tile for age and gender - Self-identified as Hispanic/Latino - Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease) - Sweetened beverage intake of at least 24 ounces/day


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT01188083


Primary Contact:

Principal Investigator
Miriam Vos, Md
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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