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Nonalcoholic Steatohepatitis clinical trials

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NCT ID: NCT04389593 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology as Reference

Start date: May 21, 2019
Phase:
Study type: Observational

This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

NCT ID: NCT04012242 Recruiting - Ultrasound Clinical Trials

Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

iLEAD
Start date: June 15, 2019
Phase:
Study type: Observational

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.

NCT ID: NCT03725631 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker 2. To develop non-invasive diagnosis marker for NASH and advanced fibrosis

NCT ID: NCT03602573 Recruiting - Menopause Clinical Trials

Liver Fibrosis in Peri-menopausal Women

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

This is a prospective observational study in a single medical center. The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers. Recruitment period: 2018/08/01 to 2019/07/31 Patient number: 200 females Inclusion criteria: 1. Females, age of 46-55 years 2. Willing and able to comply with the study requirements 3. Willing and able to provide written informed consent to participate in the study Exclusion criteria: 1. Unable to complete the noninvasive procedure of VCET and CAP 2. Unwilling to provide written informed consent to participate in the study Laboratory tests and examinations: Baseline and two follow-up visits (every 6 months): 1. Blood pressure 2. BW, BH, waist circumference, BMI 3. Complete blood cell (CBC) count 4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP 5. Sugar (fasting), HbA1c, insulin, HOMA-IR 6. DM lipid profiles, adiponectin, leptin 7. Liver ultrasound, FibroScan touch 520 8. FSH, Estrodiol (E2), LH 9. TSH, free T4 10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive) 11. ANA, Anti-mitochondrial antibody 12. Review history of drug and menstruation cycles

NCT ID: NCT02815891 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Start date: July 2016
Phase:
Study type: Observational [Patient Registry]

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.

NCT ID: NCT02792634 Recruiting - Obesity Clinical Trials

Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery

NALKOSTEP
Start date: June 2016
Phase: N/A
Study type: Observational

Obesity and obesity related health problems are globally recognized as one of the major threats to public health. Bariatric surgery is the most effective and durable therapy option for obesity and the improvement of obesity related co-morbidities. "Non alcoholic steatohepatitis" (NASH) is an important comorbidity of obesity and improves after surgical intervention. In this study investigators try to enlighten the weight independent mechanism for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will be observed for at least 24 month. A liver and adipose tissue samples are gained during the operation. Liver function and morphology are observed before and after operation with LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after surgical intervention. In order to check the microbiome stool samples are collected throughout the entire observation period.

NCT ID: NCT02764047 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

Probiotics in the Treatment of NAFLD

Start date: January 2015
Phase: N/A
Study type: Interventional

Evaluate the effect of supplementation of probiotics on liver changes (histological and enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis (NASH).

NCT ID: NCT02148471 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Fatty Acids, Genes and Microbiota in Fatty Liver

Start date: October 2003
Phase: N/A
Study type: Observational

The first aim of this study is to assess oxidative stress and nutritional status in patients with elevated liver enzymes who were found to have either simple steatosis (SS) or nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and immunohistochemistry, liver function tests, liver and red blood cell membrane fatty composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant vitamins and antioxidant power, lipid profile, subject demographics, medical history and medication use. The second aim is to detect differences in hepatic gene expression (messenger RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS or NASH and healthy controls, in addition to determine in patients with non-alcoholic fatty liver disease (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3 PUFA content and gene expression. The third aim is to determine the intestinal microbiome (microbial composition and metagenome) in patients with SS or NASH and healthy controls.

NCT ID: NCT00842205 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Role of Heme Oxygenase in the Pathogenesis of Hepatocellular Injury in Chronic Hepatitis C Virus (HCV) Infection

Start date: January 2007
Phase: N/A
Study type: Interventional

In the presented project, the role of heme oxygenase 1 and 2 in the procesess associated with fibroproduction in the chronic HCV infection will be studied. Heme oxygenase expression will be evaluated by the techniques of molecular genetics and immunohistochemistry, both in the liver tissue and in peripheral blood mononuclear cells. These parameters will be correlated with basic virological and clinical characteristics of the chronic HCV infection. The investigators' expected results may help in understanding the mechanisms of fibroproduction in chronic HVC infection and, therefore, contribute to explain individual differences in the development of chronic HCV infection.

NCT ID: NCT00699036 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

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

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?