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Fatty Liver clinical trials

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NCT ID: NCT05719480 Recruiting - Liver Cancer Clinical Trials

A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Liver Cancer

Start date: November 20, 2022
Phase:
Study type: Observational [Patient Registry]

The incidence of liver cancer in China shows a clear clinical path of hepatitis/fatty liver liver cirrhosis liver cancer. The dynamic changes of the internal environment on this pathway are important clues for early detection, diagnosis and even cure of liver cancer. The investigators carried out this study to investigate the changes of plasma and urine metabolites in different liver diseases during the occurrence and development of liver cancer.

NCT ID: NCT05712603 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

The Nijmegen-Leiden-Amsterdam 2-tiered Care Path Study

NLA2
Start date: October 1, 2022
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) is a liver disease, caused by storage of fat in the liver. The most-important risk-factors are being overweight, and disorders in sugar and cholesterol handling of the body. On average does around 30% of the population worldwide have any signs of fatty liver. Most people will not get severe complaints as a result of their fatty liver. But in some of them, the fat storage will lead to hepatitis. This causes damage to the liver which can eventually lead to scarring of the liver, and in some patients to cirrhosis. This possibly can cause liver failure, liver cancer, an several complaints which reduce the quality of life. There are several tests which can help in detecting scarring of the liver. However, the scientific world still does not know well enough which test works best and if they perhaps might work better if they are used together. In this study these questions will be investigated in order to design a care path which does several tests consecutively. The goal is that this will make it possible to easily detect a severely diseased liver and that this will eventually help to detect patients earlier so they can be treated earlier and complications of the disease might be reduced. Moreover, is the goal that this study will lead to a decrease in unnecessary referrals to a hepatologist, resulting in a reduction in invasive diagnostic interventions. Hospital specialists who think that their patient might be at risk for advanced liver disease, can refer a patient to this study. Participants will go to the hospital for one study visit where several tests will be done which are designed to detect liver scarring. Depending on the results, a participant will be referred to a hepatologist for more extensive diagnostics or referred back to the referring specialist with advice for management of the disease.

NCT ID: NCT05699018 Recruiting - Liver Fibrosis Clinical Trials

Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

SOPRANO
Start date: March 13, 2023
Phase: N/A
Study type: Interventional

The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.

NCT ID: NCT05697991 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Non-Alcoholic Fatty Liver Disease in a Saudi Cohort With Type 2 Diabetes Mellitus

CORDIAL
Start date: March 23, 2015
Phase:
Study type: Observational [Patient Registry]

The global rise in the prevalence of obesity paved the way for the increased prevalence of yet another obesity-related complication significant enough to be considered within the roster of major public health threats: non-alcoholic fatty liver disease (NAFLD). In this follow-up study, the investigators will attempt to decipher the natural history of hepatic steatosis among patients with type 2 diabetes mellitus (T2DM) using state-of-the-art methods in a well-characterized Saudi cohort. The investigators aim also to validate existing biomarkers of disease severity and explore the pathogenesis of progressive disease using metabolic profiling technologies. A total of 1000 adult Saudi patients (males and females) with T2DM will be recruited. Those with co-morbidities, including hepatic decompensation, will be excluded. Participants will be followed three times for a total of 10 years/patient (Year 2, Year 5, and Year 10), and measures such as dietary evaluations, anthropometrics, and urine, stool, and blood examinations will be performed. Patients who develop NAFLD will be noted, and patterns/changes in the metabolic profile will be examined. For this specific grant (the first 2 years of the whole project), the investigators will be able to recruit the study cohort, do the baseline anthropometric, imaging, and biochemical measurements, and report the prevalence of NAFLD among patients with T2DM. This information will be the basis of subsequent follow-up and allow for validating potential diagnostic and prognostic biomarkers. This project will be of high importance at the national level since it will create awareness in the local medical community of the current severity status of NAFLD in the kingdom and will be used as a tool to promote public health awareness in the community.

NCT ID: NCT05696808 Recruiting - Metabolic Syndrome Clinical Trials

Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD

NAFLDNutrition
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The modality of lifestyle modification including low calorie diets along with normal protein and moderate physical activity is the safest standard medical treatment for NAFLD in general. There are many benefits of weight loss to the patients with NAFLD. Besides the improvement in the features of metabolic syndrome, weight loss with IHPD would certainly improve the overall vitality and well being of the patients. The results of study will help to delineate a protocolized care for the management of NAFLD with metabolic syndrome thus helping other patients also in the future.

NCT ID: NCT05692492 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

Start date: June 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.

NCT ID: NCT05680233 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

Start date: January 23, 2023
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

NCT ID: NCT05655221 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

Start date: August 30, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects

NCT ID: NCT05654129 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease

BUCCONAFLD
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Many studies suggest that Porphyromonas gingivalis, a virulent periodontopathogenic bacterium, is associated with many systemic diseases such as cardiovascular diseases. In addition, a recent study showed the impact of Porphyromonas gingivalis on Non-Alcoholic Steatosis Liver Disease (NASH). It would be responsible for aggravation of non-alcoholic fatty liver disease (NAFLD) by stimulating inflammation in the damaged liver tissue.

NCT ID: NCT05648214 Recruiting - Healthy Volunteers Clinical Trials

A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: December 27, 2022
Phase: Phase 1
Study type: Interventional

This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment. Part A is focused on healthy participants. Part B of the study is focused on participants who are known to have NAFLD and a specific variant of the PNPLA3 gene. The aim of the study is to see how safe, tolerable and effective the study drug is. Part A is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - Explore impact of Japanese ethnicity on safety and PK (pharmacokinetics, or study of what the body does to the drug) of single doses of ALN-PNP over time Part B is looking at several other research questions, including: - What side effects may happen from taking the study drug - How the study drug works to change liver fat content in NAFLD - How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) - Better understanding of the study drug and NAFLD