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Fatty Liver clinical trials

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NCT ID: NCT06166797 Not yet recruiting - Clinical trials for Nonalcoholic Fatty Liver Disease

Elucidating Growth Hormone Dynamics at Stages of Progressive Nonalcoholic Fatty Liver Disease

Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this study is to investigate relationships between the body's growth hormone "axis" and nonalcoholic fatty liver disease. The growth hormone "axis" includes the hormones growth hormone and insulin-like growth factor 1, and associated proteins. We hypothesize that there will be a relationship such that people with more advanced nonalcoholic fatty liver disease will have greater impairments in the growth hormone axis. There are no treatments associated with this research study.

NCT ID: NCT06161571 Recruiting - NASH/MASH Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

NCT ID: NCT06160271 Not yet recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis

HEFITEP
Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD), estimated to be 17% prevalent in France, can lead to non-alcoholic steatohepatitis (NASH), which in turn can progress to fibrosis, the ultimate stage of which is cirrhosis, a major cause of liver transplantation. The prevalence of NASH is increasing worldwide, along with that of type 2 diabetes and obesity. Significant liver fibrosis is estimated to affect at least 2.6% of the adult population in France. The prognosis of patients with NASH is directly linked to the stage of liver fibrosis determined by biopsy, and these biopsies must now be repeated to assess the effect of treatments. Hepatic fibrosis is traditionally classified into five stages, from the absence of fibrosis (F0) to severe cirrhosis (F4), and passage from one stage to another is considered to demonstrate significant variation, likely to impact prognosis. However, liver biopsy is painful. It can only analyze a very small proportion of liver volume (1/50,000), whereas the distribution of fibrosis is generally heterogeneous. Above all, biopsy is not devoid of risks, primarily hemorrhage, which can sometimes be severe or even fatal. In line with current recommendations, clinical-biological algorithms, as well as ultrasound elastography or MRI, are used to assess the risk of fibrosis and the value of a liver biopsy. Generally speaking, these tests have the advantage of very good negative predictive values, making it possible to exclude the possibility of significant fibrosis in a large proportion of patients. However, their positive predictive values are weaker, even when these tests are combined. Above all, they do not allow us to follow the evolution of the fibrosis stage over time. This is why liver biopsies remain indispensable for determining the stage and severity of hepatic fibrosis and monitoring its evolution. It is therefore essential to develop more precise, non-invasive methods for accurately assessing the extent of liver fibrosis. This is the objective of the FreSH national cohort, which uses conventional biological techniques and in which our patients will also be included.

NCT ID: NCT06157125 Recruiting - Clinical trials for Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development

Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN

MFLD
Start date: June 2024
Phase:
Study type: Observational

Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States. Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1). Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2). Glomerulonephritis (GN), a complex syndrome encompassing a variety of individual disorders, is associated with significant morbidity and mortality(3). Given its association with hyperlipidaemia, metabolic syndrome and long-term use of steroid there is concern that patients with GN may be at increased risk of fatty liver disease Patients with NS are frequently found to have fatty liver disease even when adjusting for common risk factors(1). It is known that obesity is an independent risk factor for CKD and it is associated with the development of proteinuria and pathologic findings of podocyte hypertrophy and focal segmental glomerular sclerosis even in the absence of diabetes and hypertension . In addition, studies have shown that obesity as well as metabolic syndrome is a strong predictor of the development of fatty liver disease (4) . Hence, clinicians should maintain a high index of suspicion regarding presence of NAFLD in patients with NS

NCT ID: NCT06154096 Not yet recruiting - Steatosis of Liver Clinical Trials

Liver Fat and Glucagon Resistance

Start date: March 2024
Phase:
Study type: Observational

One in four adults worldwide have too much fat stored in the liver which is known as metabolic associated steatotic liver disease (MASLD). This was previously known as non- alcoholic fatty liver disease (NAFLD). This can lead to liver failure and death in severe cases. Unfortunately, there are no specific drugs to treat MASLD. Glucagon is a natural hormone that controls how the body stores and uses fuel. Glucagon acts on liver cells to use protein and fat to make sugar. It decreases the amount of liver fat. The investigators think that patients with MASLD may not respond to the actions of glucagon. This could contribute to the build-up of fat in the liver. In this study the investigators will be investigating the effects of glucagon on protein breakdown and sugar production in patients with and without MASLD. Healthy volunteers and patients with MASLD will attend for one study visit each which will last for 4-5 hours. During this time they will have infusions into a vein of glucagon and other hormones, amino acids (to mimic the fed state) and 'tracers'. From another vein they will have several blood samples during this period. By analysing these blood samples the investigators will be able to measure the effects of glucagon on protein and glucose turnover (metabolism), and whether this differs between healthy volunteers and those with MASLD. If the investigators find that patients with MASLD are resistant to the actions of glucagon, this could help with the development of drugs to treat MASLD.

NCT ID: NCT06152991 Enrolling by invitation - Clinical trials for Non-Alcoholic Fatty Liver Disease

Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy

Start date: September 25, 2023
Phase: Phase 3
Study type: Interventional

the purpose of this clinical trial is to assess the efficacy and safety of Orotic Acid Carnitine Complex Capsules (Godex®) in comparison to a placebo control group in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

NCT ID: NCT06152250 Recruiting - Liver Diseases Clinical Trials

Characterization of the Intrahepatic Inflammatory Microenvironment in Patients With Non-alcoholic Steatohepatitis

Profil-NASH
Start date: January 29, 2023
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a nosological entity that groups together non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Unlike NAFL, NASH is characterized by intrahepatic inflammation, and is solely at risk of progression to cirrhosis and hepatocellular carcinoma (HCC). It is currently estimated that NAFLD affects approximately 25% of the world's adult population, and its incidence is rising in all regions of the world. Nevertheless, of all patients with NAFLD, only ~25% have NASH. Identifying patients with NASH is therefore crucial, determining the need for follow-up to detect the onset of fibrosis and/or HCC, and eventual access to therapeutic trials. Furthermore, intrahepatic inflammation, the initial driver of NASH, appears to play an important role in the development of fibrosis and HCC, which can occur in the absence of cirrhosis in these patients. However, few studies have been carried out in humans to date, with data mainly coming from mouse models. An innovative technique, Fine-Needle Aspiration (FNA), enables to obtain cells from the liver compartment, including large numbers of immune cells. In participants with NAFLD and indication of liver biopsy, a FNA will also be performed. Forty patients will be included, with ~75% of NASH and ~25% of NAFL expected. The investigators will study the phenotypic and functional characteristics of human intrahepatic inflammatory cells obtained by the FNA with different innovative techniques (RNAseq, multiparameter immunophenotyping, single-cell secretome and phosphoproteome). Peripheral Blood Mononuclear Cells and circulating microRNAs, known to regulate immune responses, will also be analysed. The hypothesis of Profile-NASH is that intrahepatic inflammatory profiles differ between NASH and NAFL, and is associated with fibrosis progression and carcinogenesis. This pilot study, based on high-definition technologies, will provide precise new insights into the quality of intrahepatic inflammation and the mechanisms favoring the transition from NAFL to NASH and its progression. Precise analysis of the intrahepatic inflammatory microenvironment will enable the investigators to identify new players in the pathogenesis of NASH, and potential future therapeutic targets.

NCT ID: NCT06151964 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Trial to Learn How Safe AZD9550 is in People With Type 2 Diabetes Who Are Overweight or Obese

CONTEMPO
Start date: September 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

AZD9550 is in early development for the treatment of NASH, a type of liver disease that commonly affects overweight and obese patients who have T2DM. The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body.

NCT ID: NCT06144593 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes

INTERCARB
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.

NCT ID: NCT06140953 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Benefits of Trimetazidine in MAFLD Pateints

MAFLD
Start date: December 10, 2023
Phase: Phase 2
Study type: Interventional

Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MAFLD