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Fatty Liver clinical trials

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NCT ID: NCT03988725 Completed - HIV Mono Infection Clinical Trials

Nonalcoholic Steatohepatitis in HIV Mono-infection: Exploring Non-invasive Methods for Diagnosis and the Therapeutic Role of Vitamin E

Start date: November 11, 2014
Phase: N/A
Study type: Interventional

Effective combination antiretroviral therapy (cART) has resulted in a dramatic reduction in AIDS mortality. Over the last decade, the proportion of deaths caused by liver-related etiologies, including co-infection with hepatitis C (HCV) and hepatitis B (HBV) viruses, alcohol abuse, and fatty liver, has increased between 8 to 10 fold in the post-cART era while AIDS-related mortality has fallen more than 90-fold. HIV infection without viral hepatitis is also at risk for liver disease. Indeed, HIV mono-infected persons experience common conditions, such as obesity, diabetes and dyslipidemia, which are risk factors for non-alcoholic fatty liver disease (NAFLD). NAFLD is the most common liver disease in Canada. It is a fatty infiltration of the liver that is not evolutive per se, but it is the first histopathological step for non-alcoholic steatohepatitis (NASH), a progressive disease characterized by much inflammation leading to liver fibrosis and cirrhosis. NASH may be frequent in the setting of HIV mono-infection due to excess of metabolic risk factors, long-term cART, HIV itself and lipodystrophy. An early diagnosis of NASH is essential to establish a prognosis and initiate interventions to reduce progression of liver disease towards cirrhosis. Early diagnosis of NASH is critical for targeting metabolic and hepatologic interventions, which can impact on progression to cirrhosis and end-stage complications. Non-invasive tools for liver fibrosis and NASH, including Fibroscan/CAP and CK-18, are accurate and ideal for screening and serial monitoring. No study has specifically targeted the non-invasive diagnosis of NASH in HIV mono-infected patients. There has been no study about the use of CK-18 as a biomarker for NASH in the setting of HIV mono-infection. Furthermore, CAP has never been applied to this specific population. Finally, there is no data about the potential beneficial therapeutic effect of vitamin E on NASH associated to HIV infection. The investigators hypothesize that CK-18 and Fibroscan/CAP can be used as non-invasive tests to diagnose NASH in HIV mono-infected persons. Likewise, the investigators hypothesize that there will be a significant prevalence of NASH diagnosed by non-invasive tools among patients with HIV mono-infection. The investigators further hypothesize that a 6 months treatment trial with vitamin E supplementation will improve non-invasive diagnostic tests, and/or the metabolic and hepatic profile in HIV mono-infected patients with a non-invasive diagnosis of NASH.

NCT ID: NCT03987451 Completed - Clinical trials for Non-alcoholic Steatohepatitis

A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

Start date: June 18, 2019
Phase: Phase 2
Study type: Interventional

Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

NCT ID: NCT03987074 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

Start date: July 29, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

NCT ID: NCT03986684 Completed - Metabolic Syndrome Clinical Trials

Molecules Associated With the Presence and Severity of Nonalcoholic Fatty Liver Disease

NAFLD
Start date: January 5, 2017
Phase:
Study type: Observational

Non-invasive diagnosis and treatment of nonalcoholic fatty liver disease (NAFLD) remain unmet medical needs. Aim of this study is to investigate the blood levels of three hormonal systems related to obesity, insulin resistance and inflammation in patients with different stages of NAFLD, in order to identify potential diagnostic markers. Study aim: To compare the blood levels of: a) proglucagon-derived hormones (glucagon-like peptide [GLP]-1, GLP-2, glicentin, oxyntomodulin, glucagon, major proglucagon fragment [MPGF]), b) follistatins-activins (follistatin-like (FSTL)3, activin B), c) IGF axis (insulin-like growth factor (IGF)-1, total and intact IGF binding protein (IGFBP)-3 and IGFBP-4, in 18 individuals with early stage NAFLD vs. 14 controls To explore the levels of GDF-15, total and intact, in NAFLD versus obese controls (OC) at baseline and during oral glucose tolerance tests (OGTTs)

NCT ID: NCT03985020 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Start date: July 26, 2019
Phase: N/A
Study type: Interventional

In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions: 1. Standard of care 2. Water delivery 3. Water with Rebaudioside (stevia natural sweetener)

NCT ID: NCT03978247 Completed - Obesity Clinical Trials

Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy

SIGNALS
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood sample's infrared spectra

NCT ID: NCT03976687 Completed - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients

Start date: June 11, 2019
Phase: Phase 1
Study type: Interventional

This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X Receptor (FXR) agonist/modulator EYP001a in healthy volunteers and Nonalcoholic Steatohepatitis (NASH) patients.

NCT ID: NCT03976401 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Start date: May 28, 2019
Phase: Phase 2
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.

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: NCT03972319 Recruiting - Clinical trials for Bariatric Surgery Candidate

Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study

OLIVER
Start date: September 17, 2019
Phase: Early Phase 1
Study type: Interventional

Omega-3 has been postulated to reduce hepatic steatosis by reducing lipogenic gene expression, exerting anti- inflammation action, reducing oxidative stress and improving glycemic control. A recent meta-analysis by Parker et al.[1] found that omega-3 supplementation is associated with improvement in liver fat content as well as on Aspartate Aminotransferase (AST) levels. Omega-3 supplementation has also found to be useful in reducing blood triglyceride levels [2]. Recent studies by Iannelli et al. (2013) and Abidin et al.(2017) have also found that a 1 month supplementation of 1.5g/day and 2g/day of omega-3 supplementation resulted in reduced hepatic volume of 20% and 34.88 cm3 respectively. The investigator's hypothesis is that a 4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day; Each capsule Concentrated omega-3 triglycerides- fish 1000mg containing Omega-3 Marine Triglycerides 600mg as: 360mg Eicosapentaenoic acid (EPA), 240mg Docosahexaenoic acid (DHA)) taken as supplement, without any other dietary intervention pre Bariatric Surgery decreases significantly liver volume and facilitate access during surgery. And that shrinkage of liver volume also translates to improve biochemical parameters of fatty liver disease