N/A N=15 Basic Science

Genetic-specific Effects of Fructose on Liver Lipogenesis

NAFLD

Bottom Line

View on ClinicalTrials.gov: NCT03783195 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Mean Change in Liver Fat Content Based on Elastography — -0.15; 1.10 kilopascal (kPa) — p=0.40

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sugar drink (Other)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Liver Fat Content Based on Elastography	-0.15; 1.10	0.40
PRIMARY Mean Percent Change in Liver Fat Content Based on MRI	-0.54; -0.33	0.71
PRIMARY Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG)	-0.021; -0.007	0.0006 sig
PRIMARY Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG)	0.66; 0.75	0.59
SECONDARY Mean Change in Serum Concentrations of Triglycerides	21.75; -2.14	0.017 sig
SECONDARY Mean Change in AUC of Serum Triglycerides	0.59; 0.57	0.89
SECONDARY Mean Change in Serum Concentrations of HDL Cholesterol	-2.70; 0.39	0.36
SECONDARY Mean Change in AUC of Serum HDL Cholesterol	0.59; 0.66	0.67
SECONDARY Mean Change in Serum Concentrations of LDL Cholesterol	-4.40; 0.96	0.09
SECONDARY Mean Change in AUC of Serum LDL Cholesterol	0.63; 0.68	0.69
SECONDARY Mean Change in Serum Concentrations of Total Cholesterol	-2.77; 0.92	0.07
SECONDARY Mean Change in AUC of Serum Total Cholesterol	0.63; 0.66	0.80
SECONDARY Mean Changes in Serum Concentrations of Uric Acid	0.21; -0.36	0.17
SECONDARY Mean Changes in AUC of Serum Uric Acid	0.73; 0.52	0.22
SECONDARY Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT).	-0.02; -0.007	0.04 sig
SECONDARY Mean Change in AUC of Serum Alanine Transaminase (ALT)	0.66; 0.54	0.53
SECONDARY Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST).	-1.91; 1.28	0.25
SECONDARY Mean Change in AUC of Serum Aspartate Transaminase (AST).	0.61; 0.73	0.20
SECONDARY Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP)	20.38; -5.24	0.21
SECONDARY Mean Change in AUC of Serum Alkaline Phosphatase (ALP)	0.63; 0.68	0.67
SECONDARY Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT)	0.26; 0.01	0.41
SECONDARY Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT)	0.61; 0.50	0.49

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) and liver fat accumulation when exposed to fructose intake. The proposed goal will be achieved through the completion of following aims: 1. To determine the impact of prolonged exposure of fructose on hepatic lipid accumulation in Caucasian individuals with high and low genetic risk for NAFLD, 2. to determine the impact of acute exposure of fructose on hepatic DNL, and 3. to determine the relationship between markers of DNL, liver fat accumulation and serum concentrations of lipids, uric acid and liver function markers before and after the fructose challenge.

Eligibility Criteria

Inclusion Criteria

Subjects 12 - 40 years
No history of alcohol abuse (> 7 drinks per week)
History of fructose intake of 25kg/m² - 32kg/m² or 85th -99th percentile but otherwise healthy

Exclusion Criteria

ages 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 32 kg/m² or 99th percentile
Liver fat fraction >5% as per baseline MRI scan

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03783195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.