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Fatty Liver clinical trials

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NCT ID: NCT06289387 Recruiting - Type2diabetes Clinical Trials

Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes

Start date: January 20, 2024
Phase:
Study type: Observational

Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD. MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India. The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals.

NCT ID: NCT06257732 Recruiting - NAFLD Clinical Trials

Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines

Start date: January 5, 2024
Phase: N/A
Study type: Interventional

The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are: 1. How does the type and dose of exercise affect the treatment of NAFLD? 2. What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism? 3. How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD? Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.

NCT ID: NCT06225713 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Non-Alcoholic Fatty Liver Disease (PARADISE-NAFLD)

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for non-alcoholic fatty liver disease.

NCT ID: NCT06225193 Recruiting - Fatty Liver Clinical Trials

Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Start date: June 20, 2023
Phase:
Study type: Observational

In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score >7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.

NCT ID: NCT06218589 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease (NAFLD)

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

This study aims to test the utility of Velacur ultrasound as a non-invasive, rapid, point of care diagnostic tool for detecting the presence and amount of hepatic steatosis in children and adolescents aged 2 - 20 years.

NCT ID: NCT06216041 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

Start date: December 6, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.

NCT ID: NCT06215716 Recruiting - NASH With Fibrosis Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3.

NCT ID: NCT06203548 Recruiting - Fatty Liver Clinical Trials

Monitoring Changes in Hepatic Steatosis Using Continuous Controlled Attenuation Parameter

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Background: Non-alcoholic fatty liver disease (NAFLD) affects 30% of the Asian adult population and is emerging as one of the important leading causes of liver cancer and cirrhosis. Although a number of biomarkersmany have been developed for the assessment of liver fat and fibrosis, most existing studies were cross-sectional in nature. The role of these biomarkers for monitoring and response assessment remains elusive. At present, magnetic resonance imaging proton density fat fraction (MRI-PDFF) is considered the gold standard to in quantifying liver fat. The MRI-PDFF response, defined as a ≥30% relative reduction in liver fat fraction, has been shown to correlate with improved hepatic inflammation and fibrosis. However, MRI is limited by cost and availability. The cContinuous controlled attenuation parameter (CAPc) measurement by vibration controlled transient elastography is a new technology to quantify liver fat. It is a point-of-care test and has the potential to replace the MRI-PDFF as a monitoring and response biomarker in routine practice. Study plan: This prospective cohort study will include 150 patients with NAFLD who will join a 6-month lifestyle modification programme involving dietary intervention and physical training. This will create a cohort of varying degrees of liver fat reduction. Using MRI-PDFF as the reference standard, we will evaluate the accuracy of a changes in CAPc in reflecting the MRI-PDFF response and remission of NAFLD, with all non-invasive tests performed at screening and Month 6. In addition, we will test the hypothesis that the the change in CAPc is superior to the change of in other steatosis tests results (including the original CAP, abdominal ultrasonography and steatosis scores of fatty liver index, hepatic steatosis index, NAFLD liver fat score and NAFLD ridge score) in predicting the MRI-PDFF response. The area under the receiver-operating characteristics curve of the CAPc response in predicting the MRI-PDFF response will be compared with that of the other steatosis tests using the DeLong test.

NCT ID: NCT06195943 Recruiting - Exercise Clinical Trials

Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.

NCT ID: NCT06193629 Recruiting - NASH Clinical Trials

A Multicenter, Double-blind, Placebo-randomized Controlled Clinical Study on the Treatment of Non-alcoholic Steatohepatitis With Tibetan Drug Langqing Atar

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

non-alcoholic steatohepatitis (NASH) is an inflammatory liver disease caused by the accumulation of fat in liver cells. With the change of living habits and diet, the incidence of Nash continues to increase. In the early stage, NASH generally has no obvious symptoms. With the progression of the disease and the aggravation of liver damage, it may induce fatigue, loss of body mass, and pain in the right upper abdomen, which seriously affects the health of patients. There are no specific drugs to treat NASH in clinical practice. Increasing exercise, taking drugs to avoid liver damage, controlling diet and other methods can alleviate clinical symptoms to a certain extent, but the stability of disease control is poor, and it is easy to develop into cirrhosis, threatening the life safety of patients. However, there are few clinical reports on the effect of drugs on NASH. In the previous treatment of patients with liver fibrosis, our research group found that non-alcoholic steatohepatitis NASH induced liver fibrosis has a good effect, suggesting that Langqingata may improve NASH. Based on this, this study observed the total effective rate of Lang Qingata in the treatment of nonalcoholic steatohepatic NASH.