Clinical trials for the intervention of NAFLD

NCT numberTitleInterventionPhaseOutcome measures
NCT01677325The clinical trial of NAFLD treated by traditional Chinese medicineChinese herb Yiqi Sanju Formula (YQSJF)IComputed tomography (CT) ratio of liver/spleen
BMI (body mass index) and insulin sensitivity homeostatic model assessment (HOMA) index
Liver function
Lipid profile and non-esterified fatty acid (NEFA)
Adiponectin, leptin, IL-6, TNF, and hs-C-reactive protein (CRP)
NCT00230113Effect of n-3 PUFA supplementation in NAFLD patientsn-3 fatty acid diet supplementationIIReduction of intrahepatic fat content as determined by magnetic resonance spectroscopy
Change in lipid profile and serum aminotransferase levels
Change in levels of proinflammatory cytokines
Change in insulin resistance determined by HOMA
NCT04019561A study to evaluate the safety and pharmacodynamic efficacy of MEDI0382 in obese subjects with NAFLD/NASHMEDI0382, a peptide targeted on glucagon-like peptide-1 (GLP-1)IIAssess the safety and tolerability of MEDI0382
Change in hepatic fat, liver volume, and fat volume
Change in visceral adipose tissue and subcutaneous adipose tissue
Change in circulating markers of hepatic inflammation
And others
NCT02098317DHA and Vitamin D in children with biopsy-proven NAFLDDHA plus Vitamin DIIIImprovement in NAFLD activity score (NAS) and safety
Improvement of laboratory parameters of metabolic syndromes, such as lipids and gluco-insulinemic profile
NCT03970031A study of MSDC-0602K to assess glycemic control and cardiovascular outcomes in patients with pre-T2D or T2D and NAFLD/NASHMSDC-0602K, a modulator of the mitochondrial pyruvate carrierIIIChange in glycosylated hemoglobin A1c (HbA1c) from baseline to week 26
Change in the weighted average of standardized AST, cytokeratin 18 (CK-18), and HbA1c values
NCT02973295Silymarin in NAFLDSilymarin, a flavonolignan extracted from the milk thistle [Silybum marianum (L.) Gaernt.]IVChange (Reduction) of parameters of liver steatosis defined by controlled attenuation parameter (CAP) and liver fibrosis defined by liver stiffness measurements (LSM) during the 6 months
Change in liver enzymes in a period of 6 months
Change in insulin resistance in a period of 6 months
Change in lipidogram in a period of 6 months
NCT02564679Sleeve gastrectomy in adolescents with complicated morbid obesity and NAFLDLaparoscopic sleeve gastrectomy (LSG)NAImprovement of metabolic parameters
Improvement of liver parameters
Improvement of liver histology
NCT04049396Berberine and NAFLDBerberine, a chemical found in several plants such as European barberry and Oregon grapeNAChange from baseline of ALT, AST, alkaline phosphatase (ALP), TC, fasting blood sugar (FBS), TG, LDL, and high-density lipoprotein (HDL)
NCT04073368Study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLDDietary supplement AXA1125 or AXA1957NAIncidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Percent change in liver fat
Change in HOMA-insulin resistance (HOMA-IR)
Change in plasma glucose, insulin, ALT, and AST
NCT01680640Investigation of synbiotic treatment in NAFLDSynbiotic, a mixture of probiotics and prebioticsNAChange in biomarkers for NAFLD and change in liver fat
Change in adipose tissue inflammation, satiety, and risk factors for T2D
NCT03737071The effects of low carbohydrate diet on liver fat content and mitochondrial fluxesLow carbohydrate dietNAChange in hepatic triglyceride content
Change in hepatic mitochondrial flux
Change in beta-hydroxybutyrate production rate
Change in glucose production rate
NCT03193125Effects of carnitine supplementation on liver mitochondria fatty acid processingDietary supplement of L-carnitineNAChange from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge
NCT03151798Nutrient overload, insulin resistance, and hepatic mitochondrial dysfunctionLifestyle treatmentNALiver mitochondrial gene expression
Liver mitochondrial fat oxidation
Histology to determine the amount of fibrosis in the liver
NCT02457702Mitochondrial function in patients with severe liver diseaseOrally administered labeled glycerol ([U-13C3]glycerol)NADetection of 13C in plasma glucose by nuclear magnetic resonance of a blood sample
NCT03587727Hepatic fat content and mitochondrial flux in obese youth before and after bariatric surgeryWeight loss surgery or bariatric surgeryNAChanges in hepatic mitochondrial function
Changes in insulin resistance/pancreas/gastrointestinal hormones
Changes in NAFLD status via tissue
NCT03480594Effect of fatty liver on TCA cycle flux and the pentose phosphate pathway (HP FFF)Hyperpolarized [13C]pyruvate injectionIBicarbonate/lactate ratio
Labeled glycerol fraction
The fraction of [U-13C]glycerol that has passed through mitochondrial pathways prior to gluconeogenesis and the fraction of glucose, derived from [U-13C]glycerol, that has passed through the pentose phosphate pathway
NCT02344186Effects of liraglutide on endoplasmic (ER) stress in obese patients with T2DLiraglutide, a GLP-1 receptor agonistNAChanges in unfolded protein response markers

NA: not applicable