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Fatty Liver clinical trials

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NCT ID: NCT06127225 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease (NAFLD)

Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: April 28, 2023
Phase: Phase 2
Study type: Interventional

This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose of 1000 mg once daily; Proliverenol at a dose of 1000 mg twice daily; and Placebo two caplets daily for a 12-week course of therapy. Proliverenol is a bioactive fraction derived from the dried fruit of Phaleria macrocarpa (Scheff.) Boerl (Thymelaeaceae). Proliverenol possesses a hepatoprotective activity via anti-inflammation, DNA repairing, and the antiapoptosis properties. Pre-clinical study of Proliverenol showed that it exerted the hepatoprotective activity through increasing cell survival via: 1) up-regulation of DNA repair enzyme; 2) down-regulation of NF-kB, TNFα and caspase-8 expressions, to prevent ALT leakage in HepG2 cells. Proliverenol repressed ALT expression, which could also be significantly important as possible alternative mechanism for increased blood transaminase activities. Caspase-8 pathway seemed to be involved in the molecular pathway rather than directly inducing mitochondrial damage. Taken together, ethanol induced apoptosis through NF-kB-TNFα-caspase-8 pathway, and Proliverenol protected the cells from the toxicity conditions.

NCT ID: NCT06123858 Recruiting - NASH With Fibrosis Clinical Trials

Non-alcoholic Steatohepatitis Registry Platform Study

Start date: November 22, 2023
Phase:
Study type: Observational [Patient Registry]

This is a multi-center, prospective, observational registry platform study aimed at describing the clinical characteristics and diagnosis and treatment patterns of Chinese patients with nonalcoholic steatohepatitis (NASH) with fibrosis.

NCT ID: NCT06115876 Recruiting - PreDiabetes Clinical Trials

Kuwait Adult Diabetes Epidemiological Multidisciplinary (KADEM) Program

KADEM
Start date: May 23, 2022
Phase:
Study type: Observational

Kuwait and the Gulf Region lack large longitudinal studies that identify risk factors dictating the onset of prediabetes and the progression to diabetes. The Kuwait Diabetes Epidemiology Program (KDEP), previously carried out at Dasman Diabetes Institute, was designed to develop a research dataset providing a random sampling of the Kuwaiti population. The dataset contained primarily epidemiology data for healthy, prediabetic and diabetic individuals; and was designed to serve as a resource for research and prevention programs on obesity, diabetes, and metabolic syndrome. The KDEP data supported research studies at DDI to delineate risk factors for metabolic disease from the views of genetics, biochemistry, immunology and epidemiology. One of the main limitations of the KDEP study was that it only captured a cross-sectional view of the participants in terms of diabetes status as well as lack of extensive phenotyping. In the current study, the investigators aim to perform a follow up on the non-diabetic KDEP cohort participants to enrich it with detailed physiological, genetic, biochemical and environmental data and thereby to establish an association between the development of diabetes and multidimensional risk factors. the investigatorswill also recruit family members of the KDEP and RA2010-005 participants as well as others with family history of diabetes to better identify familial patterns in risk factors. The outcome of this effort will immediately serve as a scientific baseline for developing prevention strategies for the control and management of obesity, diabetes and associated complications such as cardiovascular disease. Given the magnitude of the social and economic burden of diabetes on the Kuwaiti population, longitudinal data from the KDEP Follow-up study should play an important role in establishing the incidence of T2D progression in non-diabetic participants that were enrolled in the initial study as well as of progression to diabetes complications. This will have a positive impact on the population by providing clinicians with data to better target their patient management and by supporting policy and decision-makers in developing comprehensive health promotion programs to control these diseases at the national level.

NCT ID: NCT06113003 Recruiting - HIV Clinical Trials

The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease

GLAM HIV NAFLD
Start date: April 18, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.

NCT ID: NCT06111859 Recruiting - NAFLD Clinical Trials

Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

Liver stiffness is a marker for scarring of the liver, which occurs after damage from various liver conditions. Scarring prevents normal liver function and can lead to liver failure. Fatty liver is a common cause of liver damage and can contribute to scarring. Currently, liver biopsy serves as the 'gold standard' for assessing the degree of liver scarring and fatty infiltration, guiding treatment decisions. However, liver biopsy poses a significant risk of death and unpleasant side effects, including internal bleeding and pain. Moreover, due to the small sample of liver tissue obtained during the biopsy, the results can be misleading and may not provide an accurate overview of the liver's health. Therefore, there is an unmet need for a non-invasive method of measuring liver stiffness and fat content. Ultrasound-based methods utilize various properties of ultrasound waves to assess liver stiffness and fat levels. This study aims to recruit 100-120 patients with chronic liver disease. The investigators will assess liver stiffness and fat levels during patients' hospital visits for routine scans, biopsies, or clinic appointments. The resulting measurements of liver stiffness and fat obtained through ultrasound-based methods will be compared to patients' routine liver biopsies, routine FibroScan results (another non-invasive method routinely used in clinical care to assess patients' liver stiffness), and other non-invasive severity scores (calculated from results obtained from patients' routine blood tests, providing an overview of the extent of liver damage).

NCT ID: NCT06108219 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

Start date: October 25, 2023
Phase: Phase 2
Study type: Interventional

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis (MONARCH)

NCT ID: NCT06104319 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Dose Exploration Study of GSK4532990 in Participants With NASH or Suspected NASH

SKYLINE
Start date: January 22, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24 weeks.

NCT ID: NCT06101758 Recruiting - Clinical trials for Hepatocellular Carcinoma

Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study

SARCOLIVER
Start date: October 20, 2023
Phase: N/A
Study type: Interventional

Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Even if in patients with chronic liver disease an association among sarcopenia and poor clinical outcomes is well known, the data available about the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma are very variable according to the populations in object and, furthermore, few data are available regarding the use of muscular ultrasound to detect this condition. The aim of this study is to define the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma in follow-up at our center and the clinical outcomes associated with this condition, and to determine the reliability of muscular ultrasound to diagnose the condition of sarcopenia through a comparison with other validated techniques such as computed tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry.

NCT ID: NCT06095479 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Ultrasound Liver Fat Quantification on Pediatric Patients

Start date: July 6, 2021
Phase: N/A
Study type: Interventional

This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.

NCT ID: NCT06080386 Recruiting - Clinical trials for Non Alcoholic Fatty Liver Disease

UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

UDFF
Start date: March 1, 2022
Phase:
Study type: Observational

The purpose of this study is to assess UDFF performance (compared to MRI)