Status:
COMPLETED
Genetic-specific Effects of Fructose on Liver Lipogenesis
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
NAFLD
Eligibility:
All Genders
12-40 years
Phase:
NA
Brief Summary
The primary goal of this study is to identify a set of genotypes that increase the risk for nonalcoholic fatty liver disease (NAFLD) and predispose individuals to increased de novo lipogenesis (DNL) a...
Detailed Description
BACKGROUND AND RATIONALE Non-alcoholic fatty liver disease (NAFLD) is characterized by fat accumulation in liver cells not caused by alcohol. A leading cause of chronic liver disease in the US, NAFLD ...
Eligibility Criteria
Inclusion
- Subjects 12 - 40 years
- No history of alcohol abuse (\> 7 drinks per week)
- History of fructose intake of \< 14 drinks per week
- Caucasian ethnicity
- BMI \> 25kg/m² - 32kg/m² or 85th -99th percentile but otherwise healthy
Exclusion
- ages \< 12 and \> 40 years
- Pregnant/lactating
- known alcohol abuse or fructose intake \> 14 drinks per week
- not of Caucasian ethnicity
- glucose levels \> 100 mg/dL if fasting, \> 140mg/dL if within 2 hours post meal and \> 200 mg/dL if random sample
- taking anti-hypertensive, anti-diabetic, uric acid and/or lipid-lowering medications
- known diagnosis of diabetes, fructose intolerance, chronic kidney disease, NAFLD or any liver-related disease, hypertriglyceridemia, polycystic ovary syndrome, hypothyroidism, obstructive sleep apnea, hypopituitarism and hypogonadism
- BMI \< 25kg/m² or \> 32 kg/m² or \< 85th or \> 99th percentile
- Liver fat fraction \>5% as per baseline MRI scan
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03783195
Start Date
January 25 2019
End Date
April 25 2023
Last Update
October 23 2024
Active Locations (1)
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1
UNC Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081