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Steatohepatitis, Nonalcoholic clinical trials

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NCT ID: NCT06302049 Not yet recruiting - Fatty Liver Disease Clinical Trials

Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

Start date: May 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.

NCT ID: NCT05946330 Active, not recruiting - Liver Diseases Clinical Trials

Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).

NUTRINAFLD
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose. Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.

NCT ID: NCT04932512 Active, not recruiting - Clinical trials for Steatohepatitis, Nonalcoholic

A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224

Start date: June 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement and to assess the effect on liver steatosis by magnetic resonance imaging-determined proton density fat fraction (MRI-PDFF), additional changes in NASH histologic features, liver biochemistry tests, and plasma lipid profile.

NCT ID: NCT04861012 Not yet recruiting - Clinical trials for Steatohepatitis, Nonalcoholic

Screening for Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) at Al-Rajhy Hospital Nutrition Clinic. Assiut, Egypt

Start date: September 2021
Phase: N/A
Study type: Interventional

Primary outcome Screen for MAFLD among patients attending to the Nutrition clinic in Al Rajhi hospital. Secondary outcome - Determining the degrees of fibrosis and steatosis in patients with MAFLD - Determining the rate of obesity, diabetes mellitus (DM), hypertension (HTN), hyperlipidemia in patients with MAFLD. - Determining the rate of patients with other associated chronic liver disease (CLD).

NCT ID: NCT04785937 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

ImagingNAFLD
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks. Several drugs for NASH are now in phase 2-3 trials, and if medical treatments become available, non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed. Some imaging methods have shown promising potential in fibrosis and NASH diagnosis. This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods, including ultrasound (US) and Magnetic Resonance (MR) techniques, in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the reference standard. Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study. They undergo both a liver US and a multiparametric unenhanced liver MR examination. As reference standard, histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression (FLIP) algorithm is used. Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90% sensitivity/specificity compared to liver biopsy.

NCT ID: NCT04707651 Recruiting - Clinical trials for Steatohepatitis, Nonalcoholic

Formula Diet Treatment for NASH Patients.

NASH
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.

NCT ID: NCT04284371 Terminated - Obesity, Childhood Clinical Trials

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Patients

Start date: February 10, 2016
Phase:
Study type: Observational

The prevalence of liver steatosis, steatohepatitis, fibrosis, and hemosiderosis in overweight and obese US Military dependent pediatric patients using MR Elastography and Quantitative MRI

NCT ID: NCT04175392 Terminated - Cirrhosis, Liver Clinical Trials

Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis

PRONE
Start date: January 12, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by transient elastography - an ultrasound of the liver that assess the elastic properties (density) and stiffness of the liver tissue. This study will enroll patients 18 years and older with diagnosis of NAFLD and or NASH.

NCT ID: NCT04080947 Completed - Clinical trials for Steatohepatitis, Nonalcoholic

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

Start date: August 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

NCT ID: NCT03915002 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Integrated Approaches for Identifying Molecular Targets in Liver Disease

InLi
Start date: June 13, 2019
Phase:
Study type: Observational

To provide a framework for successful clinical trials testing novel targets for therapy in liver disease. To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression. Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.