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Fatty Liver clinical trials

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NCT ID: NCT03867487 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease

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

This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.

NCT ID: NCT03848390 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).

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

The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.

NCT ID: NCT03803540 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis

FMT-NASH
Start date: May 1, 2022
Phase: Phase 1
Study type: Interventional

Human microbiota is the set of microorganisms that, in a symbiotic way, coexist and develop in the different surfaces (skin and mucous membranes) of the human body. It is estimated that it is composed of approximately 10^14 bacteria and other unicellular life forms . The gastrointestinal (GI) tract is the organ in which the microbiota reaches its greatest complexity, influencing its metabolic activities in different organs and human systems. Human microbiota plays a role in multiple homeostatic and physiological functions including energy and intermediary metabolism, normal immune responses, and even appropriate bowel development and nervous system functioning. Given its vascular supply, the liver plays important roles in metabolism and immunological functions. It receives 70% of blood supply through the portal vein which carries all metabolic products derived from GI microbiota. Non alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries (with an estimated prevalence around 25 - 40% of adults) and it is expected that the burden of disease will increase in the near future. This condition can progress through a spectrum of progressive liver damage to non alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis and liver cancer. Around 20-30% of NAFLD patients develop NASH, with a lower rate progressing further to fibrosis and cirrhosis. Currently, there is no approved pharmacological or interventional treatment for the management of this so prevalent disease, apart from changes in lifestyle aiming weight loss. The aim of the present pilot study is to assess the efficacy and safety of microbiota manipulation by means of Fecal Microbiota Transplantation in the treatment of patients with NASH.

NCT ID: NCT03801577 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Hepaxa Management of Non-alcoholic Fatty Liver Disease

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

This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.

NCT ID: NCT03760172 Not yet recruiting - Clinical trials for Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist

Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study

INSTInCT
Start date: January 7, 2019
Phase:
Study type: Observational [Patient Registry]

NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis. Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at least in a subset of patients, the development of NASH in the absence of classic metabolic risk factor. Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes co-exist. First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome. In this way, we believe that in a particular subset of NAFLD patients, NASH could be considered as an IMID, as most of the definiting features of IMIDs are present. To demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we will adress the molecular and immunophenotype characterization in liver biopsies of NASH patients with and without the co-existence of IMIDs.

NCT ID: NCT03648554 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)

REALIST
Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH. Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group. Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis. Secondary objectives: - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life. - At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.

NCT ID: NCT03625284 Not yet recruiting - Clinical trials for Non Alcoholic Fatty Liver

Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Start date: September 10, 2018
Phase: N/A
Study type: Interventional

Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.

NCT ID: NCT03604016 Not yet recruiting - Hepatitis B Clinical Trials

Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Start date: September 23, 2018
Phase: Phase 4
Study type: Interventional

Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver

NCT ID: NCT03492879 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

The aims of this study are to assess the performance of the non-invasive Electrical Impedance Technology (EIT) in evaluating the liver fibrosis stage in patients with chronic liver diseases, in comparisons with a liver biopsy and/or Shear wave elastography and Liver Ultrasonography. The second aim is comparing between Liver Ultrasonography and Electrical Impedance Technology (EIT) to quantify the hepatic steatosis grade in patients with Non Alcoholic Fatty Liver Disease (NAFLD) .

NCT ID: NCT03487068 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).