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Fatty Liver clinical trials

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NCT ID: NCT02038387 Recruiting - Clinical trials for Non Alcoholic Fatty Liver Disease

Prospective Clinical Study of the Role of the Immune Response, in Relation to Diet, in Patients Affected by Either Chronic Hepatitis C Virus (HCV) Infection or Non Alcoholic Fatty Liver Disease (NAFLD)

Start date: July 2012
Phase: N/A
Study type: Interventional

Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are characterized by a spectrum of pathological conditions ranging from an early stage of inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large differences in age and ethnic groups, while it is well known that HCV infection is a major cause of chronic liver disease in Western countries. For both diseases the progression of liver damage is in close correlation with the lifestyle of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was shown that feeding imbalances may have implications in altering the normal immune functions of the subjects, suggesting that the metabolic and the immune systems are closely related to each other. Although it is well known the negative role of obesity on the progression of NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to the immune response is not yet fully understood. Insulin resistance, altered lipid metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection. Recent studies suggest that the evolution of viral infections and chronic inflammation in NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17 (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV infection in the activation of Th17 cells and in the alteration of some of their functions, will allow to shed light on the pathogenic mechanisms underlying the progression of immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17 cells may have a role in the diminished response to therapy in patients who have high cholesterol levels. If the results will confirm our hypothesis, this study will provide useful informations for the clinical management of patients with both steatosis and chronic HCV infection. The data obtained can also be used for the development of new therapeutic strategies directed to modulate the antiviral immune response. All patients will undergo clinical and instrumental assessment depending on the type of pathology. Patients will be required to follow a normocaloric low cholesterol diet for a period of 30 days. The prospective clinical study does not present any form of additional risk for the patients and will be conducted in accordance with the principles established by the Declaration of Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require any additional costs.

NCT ID: NCT02037321 Active, not recruiting - Obesity Clinical Trials

Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk

Start date: May 2013
Phase: N/A
Study type: Observational

Vegetarian diets have been associated with a reduced risk of preventable diseases such as type 2 diabetes and cardiovascular disease. These effects may be mediated through direct or indirect pathways. Although the high intakes of nuts, legumes, dietary fibre, whole grains, and unsaturated plant oils have each individually been associated with lower risk of type 2 diabetes and cardiovascular disease, so too has the displacement of red meats, processed meats, and saturated animal fats. One of the most important considerations in moving from animal-based diets to more plant-based diets is the replacement of animal proteins (e.g. meat, fish, dairy, eggs) with vegetable proteins (e.g. legumes, nuts, and seeds). It is unclear whether this particular replacement alone results in advantages for metabolic and cardiovascular health. To improve evidence-based guidance for dietary guidelines and health claims development, we propose to conduct a series of systematic reviews and meta-analyses of the effect of plant-based protein in exchange for animal protein on blood lipids, glycemic control, blood pressure, body weight, uric acid, markers of non-alcoholic fatty liver disease (NAFLD), and kidney function and injury. The systematic review process allows the combining of the results from many small studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether the effects of replacing animal-based protein for plant-based protein hold true across different sexes, age groups, and background disease states and whether the effect depends on the protein source, dose, or background diet. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing recommendations for the general public, as well as those at risk of heart disease and diabetes.

NCT ID: NCT02031913 Completed - Chronic Hepatitis B Clinical Trials

Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD

Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.

NCT ID: NCT02030977 Completed - Clinical trials for Non Alcoholic Fatty Liver

The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

NCT ID: NCT02029586 Terminated - Clinical trials for Nonalcoholic Fatty Liver Disease

Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis

Start date: January 2013
Phase: Phase 2
Study type: Interventional

This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.

NCT ID: NCT02019056 Completed - Alcoholic Hepatitis Clinical Trials

Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.

NCT ID: NCT02018237 Completed - Obesity Clinical Trials

High Fructose Corn Syrup

Fructose
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.

NCT ID: NCT02009592 Completed - Fatty Liver Clinical Trials

Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

Start date: June 2013
Phase: N/A
Study type: Interventional

Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style, type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression. Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly accumulating over the past few years. Endotoxemia resulting from intestinal bacterial overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and partial alleviate from NAFLD/NASH.

NCT ID: NCT02006498 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.

NCT ID: NCT01999101 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD patients and to assess the influence of Px-104 on hepatic fat.