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Fatty Liver clinical trials

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NCT ID: NCT04643795 Completed - Hepatic Impairment Clinical Trials

Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects

Start date: October 25, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function, including a subset of NASH subjects.

NCT ID: NCT04642261 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Effect of Empagliflozin on Liver Fat in Non-diabetic Patients

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25%. Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and liver stiffness measurement (LSM) are non-invasive methods to diagnose hepatic steatosis and fibrosis/cirrhosis, respectively. The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of empagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients without DM. A total of 98 adult patients will be randomly sampled from the liver clinic in our local hospital. Empagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be manufactured to be identical in appearance to the study drug. Eligible subjects will be followed up until week 52, and will undergo clinical, anthropometric and laboratory assessments (including liver function test and fasting blood) at baseline, week 6, 12, 26, 40 and 52. They will undergo LSM at baseline, week 26 and 52, and MRI-PDFF at baseline and week 52. The primary outcome will be a difference in change of liver fat content (measured by MRI-PDFF) at week 52 from baseline between the two groups. The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis in NAFLD patients without DM.

NCT ID: NCT04640324 Completed - Insulin Resistance Clinical Trials

Effect of PNPLA3, TM6SF2 and MBOAT7 Genetic Variants on Non-alcoholic Fatty Liver Disease Therapeutic Outcome.

Start date: January 16, 2017
Phase: N/A
Study type: Interventional

Patatin-like phospholipase domain-containing protein-3 (PNPLA3), the transmembrane 6 superfamily member 2 protein (TM6SF2) and membrane bound O-acyltransferase domain containing 7 (MBOAT7) genes are involved in non-alcoholic fatty liver disease (NAFLD) development and worsening. Following the actual scientific knowledge, some studies have identified the genetic background surrounding NAFLD, counting up to forty different genetic variants that seem to exert also a crucial role in the disease evolution, according to the natural history, until hepatocellular carcinoma onset. However, few data exist regarding their influence on the treatment response. The aim was to explore the effect of 303 mg of silybin-phospholipids complex, 10 mg of vitamin-D and 15 mg of vitamin-E twice a day for six months in NAFLD patients carrying PNPLA3-rs738409, TM6SF2-rs58542926 and MBOAT7-rs641738 genetic variants. The assessed mutations are independently associated with no response to a silybin/vitamin D-based therapy and could be useful therapeutic predictive markers in this context.

NCT ID: NCT04618744 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)

Start date: November 24, 2020
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.

NCT ID: NCT04616014 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)

NCT ID: NCT04598685 Completed - Obesity Clinical Trials

Early Vascular Ageing in the YOUth

EVA4YOU
Start date: February 1, 2021
Phase:
Study type: Observational

This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity. A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

NCT ID: NCT04579874 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.

Start date: January 7, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the clinical performance of LIVERFAStTM In Vitro Diagnostic (IVD) Tests (Fibrosis score, Activity score and Steatosis score) in NAFLD suspected patients for staging of fibrosis and for grading of inflammatory activity and steatosis, taking as reference the liver biopsy with histological classification of the elementary lesions determined according to SAF scores (Bedossa P., Hepatology 2012). The secondary objective is to assess the performance of LIVERFAStTM for the histological definition of NAFLD, including NAFL and NASH and severe NASH

NCT ID: NCT04573543 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

The Role of Immune Semaphorins in NAFLD

SepsisFAT
Start date: September 1, 2020
Phase:
Study type: Observational

To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.

NCT ID: NCT04571957 Completed - Clinical trials for Non Alcoholic Steatohepatitis

Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization

Start date: December 1, 2018
Phase:
Study type: Observational

Live donor liver transplantation (LDLT) is the treatment of choice for end-stage liver disease, predominantly in the East, where deceased donor liver transplantation is sparse. In LDLT, donor selection has to be stringent; as the donor safety is thepriority. Live liver donors (LLD) with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise. One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis, which can increase the donor risk. Retrospective analysis of donors with non-alcoholic steatohepatitis(NASH) who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed.

NCT ID: NCT04569396 Completed - Hypertension Clinical Trials

Bariatric Surgery and Fatty Liver Disease

Start date: January 12, 2016
Phase:
Study type: Observational

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.