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Fatty Liver clinical trials

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NCT ID: NCT01997424 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease (NAFLD)

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

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

This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination: - Transient Elastography and Controlled Attenuation Parameter using the FibroScan - blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.

NCT ID: NCT01992809 Completed - Fatty Liver Clinical Trials

Omega 3 Supplementation in Fatty Liver

OMEGA 3 NASH
Start date: September 2009
Phase: Phase 3
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD), has emerged as a clinically important type of chronic liver disease in industrialized countries and is characterized pathologically by hepatocellular ballooning, Mallory's hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur post transplantation.In the absence of established treatment, therapy is generally directed to treatment of risk factors for metabolic syndrome. Recently, some studies have been demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa, IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound. Neverthless, this is the first study that evaluate liver histology after six months of PUFA (omega3) in the treatment of patients with NASH.

NCT ID: NCT01985009 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Prospective, Cross-sectional and Multicenter Study, Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease Using Liver Biopsy as Reference.

Start date: January 2014
Phase: N/A
Study type: Interventional

The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis (NASH), and then onto cirrhosis where there is a concomitant risk of developing hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high, ranging from 16 to 31% in the general population, up to 80% in the obese populationand up to 96% in severely obese patients. Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of patients with NAFLD, although it has several limitations. LB has a potential sampling error, is an invasive and often painful procedure. The natural history of patients with NAFLD is generally determined by the extent of liver fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide information on the patient's course and/or response to treatment. Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD. Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation between steatosis assessed histologically and using CAP. The main objective of this prospective study is to evaluate the diagnosis accuracy of the Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in patients with NAFLD to assess liver steatosis using biopsy as a reference. The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy within 2 weeks of fibroscan examination and followed by the Hepatology service of four centers in United Kingdom. Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study: Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe. The inclusion period is from 18 to 24 months. Starting date: January 2014. End of recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days, depending to the exams calendar.

NCT ID: NCT01975935 Completed - Obesity Clinical Trials

Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.

NCT ID: NCT01966627 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Genetics of Fatty Liver Disease in Children

Start date: July 2011
Phase: N/A
Study type: Observational

This is a study to investigate genetic predisposition to hepatic steatosis and the expression of gluconeogenic and lipogenic genes in livers of obese children and adolescents. Hypothesis 1: Common variants recently associated with variation in plasma TG levels identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD). Gene variants act in additive or synergistic manner with progressive liver fat accumulation per additional risk allele. Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase. Furthermore, expression of lipogenic markers (SREBP1c) will increase.

NCT ID: NCT01958411 Completed - Atherosclerosis Clinical Trials

Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)

Start date: December 2008
Phase: N/A
Study type: Observational

- Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques. - Non-alcoholic fatty liver disease (NAFLD) is closely associated with many cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation using computed tomography (CT). - Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is an independent marker of cardiovascular events in the general population. - Therefore, the purpose of this investigators study is to compare the NAFLD severity and EAT volume with FDG uptake measured by PET/CT.

NCT ID: NCT01940263 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Start date: June 2013
Phase: Phase 0
Study type: Interventional

Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.

NCT ID: NCT01934777 Completed - Obesity Clinical Trials

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

NCT ID: NCT01919294 Completed - Hypogonadism Clinical Trials

Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)

TEREPINS
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months 1. improve severity of steatosis on liver biopsy (Primary Question)? 2. improve severity of associated steatohepatitis on liver biopsy? 3. reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)? The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.

NCT ID: NCT01900015 Completed - HIV Infection Clinical Trials

Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

STERAL
Start date: February 3, 2014
Phase: Phase 4
Study type: Interventional

Primary Objective: To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient. Secondary Trial Objective: 1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs. 2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50 copies/mL) after switching. Design: Open-label, randomized clinical trial to evaluate safety (phase IV) Condition: HIV and HCV coinfection. Intervention: Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.