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Fatty Liver clinical trials

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NCT ID: NCT01619215 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

The Effects of Bariatric Surgeries on Non-Alcoholic Fatty Liver Disease

Start date: June 2012
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease. In the absence of chronic alcohol abuse or other liver diseases, NAFLD incorporates a wide spectrum of liver pathologies and is defined by fatty infiltration of the liver (simple hepatosteatosis). It can progress to non-alcoholic steatohepatitis (NASH) and later fibrosis, cirrhosis, and eventually some patients may develop hepatocellular carcinoma with or without cirrhosis. The exact cause of NAFLD is yet to be cleared and it is, therefore, an active area for research. The diagnosis of NAFLD is achieved through histological examination of liver biopsies (invasive), non-invasive markers using serum biomarkers and imaging techniques are still under development. Pathological diagnosis can be then subcategorized based on several scoring systems. More widely used are the Brunt Score or NAS (NAFLD activity score) and the Kleiner's modified NAS. Obesity is highly associated with NAFLD, as the epidemic of obesity has made NAFLD more prevalent. In addition insulin resistance has been linked to NAFLD and this is explained by the increased influx of free fatty acids (FFAs) into the liver. FFA undergoes either β-oxidation or esterification with glycerol to form triglycerides (TGs), resulting in an additional source of fat in the liver. Due to the strong association of NAFLD with obesity, weight reduction procedures are used for the management of NAFLD. In fact, this has been shown to be effective by several studies. However, other studies have reported liver deterioration after bariatric intervention. This conflict is what makes the effects of bariatric procedures a challenging field for further studies. Consequently in this study we are aimed to examine histologic, metabolic and liver function changes induced by the different therapeutic bariatric procedures.

NCT ID: NCT01617772 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

NALCAT
Start date: January 1, 2016
Phase: Phase 2
Study type: Interventional

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

NCT ID: NCT01579162 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation

Repro
Start date: January 2012
Phase: N/A
Study type: Interventional

HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.

NCT ID: NCT01571063 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

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

Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters. - Trial with medicinal product

NCT ID: NCT01556113 Completed - Clinical trials for Hypertriglyceridemia

Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease

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

To explore whether there is a different response to omega-3 fatty acid rich diet with respect to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor allele (GG) and the common allele homozygous (CC) of PNPLA3. Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention than the common allele homozygous supplementation.

NCT ID: NCT01553500 Completed - Metabolic Syndrome Clinical Trials

Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

GC-NASH
Start date: June 2011
Phase: Phase 2
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis. Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD. Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.

NCT ID: NCT01548079 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Ursodeoxycholic Acid in Bariatric Surgery

Start date: October 2008
Phase: N/A
Study type: Interventional

In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively, histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal ultrasound will be repeated.

NCT ID: NCT01547910 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.

NCT ID: NCT01544751 Recruiting - Clinical trials for Nonalcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin

Start date: September 2011
Phase: N/A
Study type: Interventional

The first line approach to NAFLD is currently based on diet and lifestyle modification. Aim of our Unit is to compare the efficacy of two different doses of metformin (1 g/day and 2 g/day) with atorvastatin (20 mg/day) on amelioration of inflammatory and cardiometabolic parameters, ultrasound signs and clinical scores associated with liver fibrosis in early-stage NAFLD non-diabetic patients.

NCT ID: NCT01543646 Recruiting - Liver Cirrhosis Clinical Trials

Multiparametric MR for Rapid Imaging Assessment of the Liver

RIAL
Start date: March 2011
Phase: N/A
Study type: Observational

The RIAL study aims to investigate whether non-invasive measurement of liver fat, iron content and fibrosis are as accurate as liver biopsy specimens in determining if patients have non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), or other suspected liver disease. Currently, the gold-standard for the diagnosis and staging of liver disease is a liver biopsy. In this study, consecutive patients will be offered a multiparametric MR scan to assess their liver while they await a liver biopsy. Study time-frame: The scan will be performed in the 6-week period before their biopsy, and results will be compared to biopsy findings. results will be presented at the end of the study when MR data outcomes are compared to gold-standard biopsy dat. Participants will only have to attend one study visit to participate - there will be no patient follow-up.