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Steatohepatitis clinical trials

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NCT ID: NCT05946330 Active, not recruiting - Liver Diseases Clinical Trials

Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).

NUTRINAFLD
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose. Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.

NCT ID: NCT05864391 Terminated - Steatohepatitis Clinical Trials

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.

Start date: March 31, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.

NCT ID: NCT05640947 Recruiting - Hypoglycemia Clinical Trials

Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass

LABOR
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.

NCT ID: NCT04063826 Active, not recruiting - Steatohepatitis Clinical Trials

PET-MR Study of Fatty Liver

iDOSH
Start date: April 10, 2018
Phase: N/A
Study type: Interventional

This is a pilot, translational study designed to explore the feasibility of molecular imaging with FBA-A20FMDV2, radiolabelled with fluorine-18 ([18F]-FBA-A20FMDV2), in patients with SH and CASH in hepatic metastatic disease. FBA-A20FMDV2, a synthetic peptide derived from the foot and mouth disease virus (FMDV), has been shown pre-clinically to specifically bind to the epithelial specific integrin αvβ6 which is known to be overexpressed in tumours. In this study, we aim to evaluate the uptake of [18F]-FBA-A20FMDV2 ([18F]-IMAFIB) in patients with SH and CASH in CRC hepatic metastatic disease using PET. Up to ten subjects will undergo [18F]-FBA-A20FMDV-PET scanning. An adaptive study design will enable us to determine the optimal imaging protocol for future studies.

NCT ID: NCT03915002 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Integrated Approaches for Identifying Molecular Targets in Liver Disease

InLi
Start date: June 13, 2019
Phase:
Study type: Observational

To provide a framework for successful clinical trials testing novel targets for therapy in liver disease. To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression. Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.

NCT ID: NCT02378259 Active, not recruiting - Obesity Clinical Trials

Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity

AMOS2
Start date: August 15, 2014
Phase: N/A
Study type: Interventional

Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.

NCT ID: NCT02009592 Completed - Fatty Liver Clinical Trials

Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients

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

Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style, type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression. Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly accumulating over the past few years. Endotoxemia resulting from intestinal bacterial overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and partial alleviate from NAFLD/NASH.

NCT ID: NCT01645852 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection

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

The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.

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: NCT01523639 Terminated - Colorectal Cancer Clinical Trials

A Randomized, Placebo-controlled, Double-blind Phase II Study Evaluating if Glucophage Can Avoid Liver Injury Due to Chemotherapy Associated Steatosis

G-LUCAS
Start date: April 2012
Phase: Phase 2
Study type: Interventional

This multicenter randomized, placebo-controlled phase II study will enroll 132 first-line palliative treated subjects with metastatic KRAS wild type CRC. Subjects with histologically confirmed, KRAS wild-type CRC without previous chemo-therapy for metastatic disease will be screened for this study. Approximately 10 sites in Austria will participate in the study. Subjects will be randomized in a ratio of 1:1 into two groups.