Clinical trials for the intervention of NAFLD
NCT number | Title | Intervention | Phase | Outcome measures |
---|---|---|---|---|
NCT01677325 | The clinical trial of NAFLD treated by traditional Chinese medicine | Chinese herb Yiqi Sanju Formula (YQSJF) | I | Computed 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) | ||||
NCT00230113 | Effect of n-3 PUFA supplementation in NAFLD patients | n-3 fatty acid diet supplementation | II | Reduction 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 | ||||
NCT04019561 | A study to evaluate the safety and pharmacodynamic efficacy of MEDI0382 in obese subjects with NAFLD/NASH | MEDI0382, a peptide targeted on glucagon-like peptide-1 (GLP-1) | II | Assess 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 | ||||
NCT02098317 | DHA and Vitamin D in children with biopsy-proven NAFLD | DHA plus Vitamin D | III | Improvement in NAFLD activity score (NAS) and safety |
Improvement of laboratory parameters of metabolic syndromes, such as lipids and gluco-insulinemic profile | ||||
NCT03970031 | A study of MSDC-0602K to assess glycemic control and cardiovascular outcomes in patients with pre-T2D or T2D and NAFLD/NASH | MSDC-0602K, a modulator of the mitochondrial pyruvate carrier | III | Change 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 | ||||
NCT02973295 | Silymarin in NAFLD | Silymarin, a flavonolignan extracted from the milk thistle [Silybum marianum (L.) Gaernt.] | IV | Change (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 | ||||
NCT02564679 | Sleeve gastrectomy in adolescents with complicated morbid obesity and NAFLD | Laparoscopic sleeve gastrectomy (LSG) | NA | Improvement of metabolic parameters |
Improvement of liver parameters | ||||
Improvement of liver histology | ||||
NCT04049396 | Berberine and NAFLD | Berberine, a chemical found in several plants such as European barberry and Oregon grape | NA | Change from baseline of ALT, AST, alkaline phosphatase (ALP), TC, fasting blood sugar (FBS), TG, LDL, and high-density lipoprotein (HDL) |
NCT04073368 | Study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD | Dietary supplement AXA1125 or AXA1957 | NA | Incidence 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 | ||||
NCT01680640 | Investigation of synbiotic treatment in NAFLD | Synbiotic, a mixture of probiotics and prebiotics | NA | Change in biomarkers for NAFLD and change in liver fat |
Change in adipose tissue inflammation, satiety, and risk factors for T2D | ||||
NCT03737071 | The effects of low carbohydrate diet on liver fat content and mitochondrial fluxes | Low carbohydrate diet | NA | Change in hepatic triglyceride content |
Change in hepatic mitochondrial flux | ||||
Change in beta-hydroxybutyrate production rate | ||||
Change in glucose production rate | ||||
NCT03193125 | Effects of carnitine supplementation on liver mitochondria fatty acid processing | Dietary supplement of L-carnitine | NA | Change from baseline in liver mitochondrial fatty acid processing during high-fructose drink challenge |
NCT03151798 | Nutrient overload, insulin resistance, and hepatic mitochondrial dysfunction | Lifestyle treatment | NA | Liver mitochondrial gene expression |
Liver mitochondrial fat oxidation | ||||
Histology to determine the amount of fibrosis in the liver | ||||
NCT02457702 | Mitochondrial function in patients with severe liver disease | Orally administered labeled glycerol ([U-13C3]glycerol) | NA | Detection of 13C in plasma glucose by nuclear magnetic resonance of a blood sample |
NCT03587727 | Hepatic fat content and mitochondrial flux in obese youth before and after bariatric surgery | Weight loss surgery or bariatric surgery | NA | Changes in hepatic mitochondrial function |
Changes in insulin resistance/pancreas/gastrointestinal hormones | ||||
Changes in NAFLD status via tissue | ||||
NCT03480594 | Effect of fatty liver on TCA cycle flux and the pentose phosphate pathway (HP FFF) | Hyperpolarized [13C]pyruvate injection | I | Bicarbonate/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 | ||||
NCT02344186 | Effects of liraglutide on endoplasmic (ER) stress in obese patients with T2D | Liraglutide, a GLP-1 receptor agonist | NA | Changes in unfolded protein response markers |
NA: not applicable