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Fatty Liver clinical trials

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NCT ID: NCT04281303 Not yet recruiting - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Endoscopic Bariatric Therapy in NASH Cirrhosis

ETHIC
Start date: April 1, 2020
Phase:
Study type: Observational

Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. The standard treatment is weight loss with diet and physical exercise, which has shown a histological and analytical improvement in patients who achieve a 5-10% reduction in body weight. However, less than 25% of subjects achieve this goal. Restrictive surgical treatments and gastric bypass have achieved, in obese patients, an improvement in metabolic syndrome, insulin resistance and liver histology, but in patients with liver cirrhosis the morbidity-mortality of this surgery is high. Currently, endoscopic techniques are being developed, which are less invasive and have fewer complications, and which also achieve gastric restriction with similar characteristics to those obtained by the surgical method. Among them is the tubulization or vertical gastroplasty with the OverStitch system (Apollo Endosurgery, Austin, TX, USA). However, this method has not been evaluated in patients with obesity and/or metabolic syndrome and NASH cirrhosis. For this reason, the main objective of the investigators study is to evaluate the safety and efficacy of endoscopic gastroplasty in improving metabolic factors and liver histology in patients with obesity with or without metabolic syndrome and NASH-compensated cirrhosis.

NCT ID: NCT04255069 Not yet recruiting - Clinical trials for Nonalcoholic Steatohepatitis (NASH) With Fibrosis

A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis

NCT ID: NCT04240145 Not yet recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Non Alcoholic Steatohepatitis in Relation to Visceral and Subcutaneous Fat

Start date: February 1, 2020
Phase:
Study type: Observational

Evaluate the relationship between the severity of fatty liver in NAFLD assessed by ultrasonography and CT and the visceral fat area measured by CT

NCT ID: NCT04220450 Not yet recruiting - Heart Failure Clinical Trials

T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease

Start date: June 1, 2020
Phase:
Study type: Observational

On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.

NCT ID: NCT04191044 Not yet recruiting - Fatty Liver Disease Clinical Trials

Portal Hypertension in Non-alcoholic Fatty Liver Disease: Association With Cardiovascular Risk and Identification of Non-invasive Biomarkers (THESIS)

THESIS
Start date: January 10, 2020
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic liver disease in our environment. Preliminary data suggest that portal hypertension may exist in the initial phases of NAFLD due to mechanisms that have not yet been elucidated. The clinical relevance of its development in these initial phases is unknown, while in more advanced phases new data are required to confirm the close relationship between portal hypertension and the risk of decompensation described in other etiologies. Likewise, the influence of fibrosis and portal hypertension on the cardiovascular risk of patients with NAFLD is unknown. The aim of the present multicenter project is to characterize the presence of portal hypertension and the mechanisms involved in its development in the different stages of NAFLD, to assess the association between the degree of portal hypertension and the development of portal hypertension-related complications, to know the early cardiovascular risk in the different stages of the disease, and to identify noninvasive biomarkers of the presence and severity of portal hypertension.

NCT ID: NCT04127370 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

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

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

NCT ID: NCT04099147 Not yet recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease (NAFLD)

Diagnosis and Characterization of Non-Alcoholic Fatty Liver Disease Based on Artificial Intelligence.

NASHAI
Start date: September 30, 2019
Phase:
Study type: Observational

A key element in the diagnosis of non-alcoholic fatty liver disease (NAFLD) is the differentiation of non-alcoholic steatohepatitis (NASH) from non-alcoholic fatty liver (NAFL) and the staging of the liver fibrosis, given that patients with NASH and advanced fibrosis are those at greatest risk of developing hepatic complications and cardiovascular disease. There are still no available non-invasive methods that allow for correct diagnosis and staging of NAFLD. The implementation of Artificial Intelligence (AI) techniques based on artificial neural networks and deep learning systems (Deep Learning System) as a tool for medical diagnoses represents a bona fide technological revolution that introduces an innovative approach to improving health processes.

NCT ID: NCT03972631 Not yet recruiting - Obesity Clinical Trials

Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults

Start date: July 2019
Phase: N/A
Study type: Interventional

Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.

NCT ID: NCT03970031 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH

Start date: June 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.

NCT ID: NCT03968354 Not yet recruiting - NAFLD Clinical Trials

NASH and Type 2 Diabetes: Role of the Receptor Activator of Nuclear Factor-κB (RANK) and Its Ligand (RANKL)

NADRANK-1
Start date: February 2020
Phase:
Study type: Observational

Non-alcoholic fatty liver diseases (NAFLD) include several entities ranging from simple steatosis to hepatic fibrosis or cirrhosis. Steatosis, considered benign and the first stage of the disease, is characterized by the accumulation of triglycerides in the liver. It may in some cases progress to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of a marked inflammation with or without fibrosis. NAFLD is the most common liver disease in the world and is particularly associated with type 2 diabetes (T2D) (80% in the diabetic population). While NASH is characterized by a higher prevalence of mortality from a cardiac and hepatic (cirrhosis and cancer) origin, therapeutic resources are almost non-existent. RANK (receptor activator of NF-kB) and its ligand RANKL (a member of the TNFalpha family) have emerged in recent years as new players in bone pathophysiology. By binding to its receptor, RANKL induces a number of signaling pathway and in particular the NF-kB pathway (Nuclear factor-kB), a major player in inflammation. Recent literature shows that the role of RANK / RANKL is not confined to the bone but may be involved in the genesis of inflammation in other tissues. It has been shown recently that a high circulating level of RANKL was a risk factor predictor of T2DM. Furthermore, the invalidation of RANK specifically in hepatocytes protects from insulin resistance and hepatic steatosis induced by a high fat diet in mice. The aim of our project is to provide a proof of concept that the RANKL / RANK system plays an important role in the pathogenesis of NAFLD and in the progression of this disease to NASH. The aim of our project is to provide a proof of concept that the RANKL / RANK system plays an important role in the pathogenesis of NAFLD and in the progression of this disease to NASH. The investigator propose to study the RANKL / RANK expression in serum and liver biopsies of type 2 diabetic patients at different stages of NAFLD.