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Fatty Liver clinical trials

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NCT ID: NCT04985188 Not yet recruiting - Diagnoses Disease Clinical Trials

Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Start date: August 12, 2021
Phase:
Study type: Observational

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard

NCT ID: NCT04982328 Completed - Covid19 Clinical Trials

COVID-19 and Nonalcoholic Fatty Liver Disease

CovidFAT
Start date: April 1, 2021
Phase:
Study type: Observational

COVID-19 is currently the leading public health problem, associated with a high risk of complications and death in risk groups of patients. Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease with a prevalence of 30% in the Western population and is also recognized as an independent risk factor for the development of severe COVID-19. In the pathogenesis of COVID-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm leading to the development of severe forms of pneumonia, acute respiratory and multiorgan failure. The aim of this study is to investigate the clinical course, outcomes, and profile of inflammatory response in patients with COVID-19 and NAFLD.

NCT ID: NCT04977661 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients

Start date: February 1, 2020
Phase: Phase 4
Study type: Interventional

We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 included 34 patients received Vit. E 400 mg twice a day, group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34 patients received PTX 400 mg twice daily for 3 months. The following parameters were measured both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride, LDL, HDL.

NCT ID: NCT04976283 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver

Start date: September 15, 2021
Phase: Phase 4
Study type: Interventional

This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin and/or DDP4 inhibitors.

NCT ID: NCT04972396 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

ALT-801 DDI Study in Healthy Volunteers

Start date: October 5, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (OC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without ALT-801 administration and the second is with ALT-801 at steady state.

NCT ID: NCT04971785 Active, not recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

WAYFIND
Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.

NCT ID: NCT04971434 Recruiting - Fatty Liver Clinical Trials

Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping

Start date: July 11, 2021
Phase: N/A
Study type: Interventional

Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.

NCT ID: NCT04969744 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Impact of Cold Exposure on Metabolic Regulation in Children With Non Alcoholic Fatty Liver Disease (NAFLD)

ICE BAT
Start date: October 23, 2021
Phase: N/A
Study type: Interventional

The aim of this project is to generate pilot data for a grant proposal to evaluate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in children with non-alcoholic fatty liver disease (NAFLD). The condition NAFLD is the most common liver disease in both adults and children. There are many emerging drug therapies for NAFLD but at considerable cost in terms of potential side effects. In a mouse model of diet-induced obesity, ICE was shown to help activate BAT, which may help NAFLD and other obesity associated health risks. Given that children have more BAT than adults, we hypothesise that intermittent cold exposure via a cooling vest in children with NAFLD will increase BAT stores or function. We will investigate whether intermittent cold exposure via a cooling vest device will stimulate BAT and also establish whether the cooling vest is acceptable to children and young people. If it is acceptable and has an impact on BAT function this could be a new treatment to reduce the severity of metabolic disorders associated with obesity, particularly fatty liver, e.g. hepatic steatosis. In stage 1, we will investigate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in young people aged 16 to 26 years old, as a feasibility study to optimise the cooling process. In stage 2, we will investigate the impact of ICE on BAT and WAT function in 8-16 year olds with non-alcoholic fatty liver disease (NAFLD) and matched controls. Participants will have thermal imaging, MRI scans and provide samples before and after wearing the cooling vest.

NCT ID: NCT04951219 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Start date: July 9, 2021
Phase: Phase 3
Study type: Interventional

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

NCT ID: NCT04946786 Not yet recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease NAFLD

Clinical, Biochemical and Body Composition Analysis in Assessment of Steatosis in Non Alcoholic Fatty Liver Disease

Start date: July 1, 2021
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) includes a spectrum of liver disorders characterized by accumulation of hepatic fat in absence of significant alcohol consumption (<20 gm/day) and other causes of liver diseases. It is the most common cause of asymptomatic elevation of liver enzymes worldwide (Marchesini et al., 2003). Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate. While a number of non- or minimally invasive tests are able to rule out fibrosis or cirrhosis, no single test to identify steatosis, to early diagnose NASH, or to predict the disease progression is available. Moreover, specialized, combined tests are required to assess treatment response in clinical trials on emerging compounds (Piazzolla and Mangia, 2020). Among minimally invasive tools, plasma biomarkers and composite scores defined as "wet biomarkers" are commonly used. For example, fasting insulin level and its use in measurement of insulin resistance, Lipid Accumulation Product (LAP) score (Bedogni et al., 2010), the NAFLD Liver Fat Score (NLFS) (Kontronen et al., 2009), Hepatic Steatosis Index (HSI) (Lee et al., 2010), controlled attenuation parameter (CAP) measurement by fibroscan (Piazzolla and Mangia, 2020). Recent studies have shown that CAP significantly correlates with the percentage of steatosis and steatosis grade and that median CAP is higher among patients with significant steatosis (Sasso et al., 2012 & Karlas et al., 2017). The prevalence of NAFLD is 80-90% in obese, 30-50% in patients with diabetes and up to 90% in patients with hyperlipidemia (Abenavoli et al., 2014) Central obesity or visceral fat (VF) (determined by waist circumference (WC)) is defined as the presence of excess fat in the abdomen, and this type of obesity is often associated with the development and progression of NAFLD or more advanced forms of liver disease (Abenavoli et al., 2016). Thus, measurement of body composition rather than BMI may be helpful in the prediction of NAFLD (Milić et al., 2014 and Abenavoli et al., 2016) There is a growing need to assess the steatosis in NAFLD patients using minimally invasive tools.