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Fatty Liver clinical trials

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NCT ID: NCT03803540 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis

FMT-NASH
Start date: May 1, 2022
Phase: Phase 1
Study type: Interventional

Human microbiota is the set of microorganisms that, in a symbiotic way, coexist and develop in the different surfaces (skin and mucous membranes) of the human body. It is estimated that it is composed of approximately 10^14 bacteria and other unicellular life forms . The gastrointestinal (GI) tract is the organ in which the microbiota reaches its greatest complexity, influencing its metabolic activities in different organs and human systems. Human microbiota plays a role in multiple homeostatic and physiological functions including energy and intermediary metabolism, normal immune responses, and even appropriate bowel development and nervous system functioning. Given its vascular supply, the liver plays important roles in metabolism and immunological functions. It receives 70% of blood supply through the portal vein which carries all metabolic products derived from GI microbiota. Non alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries (with an estimated prevalence around 25 - 40% of adults) and it is expected that the burden of disease will increase in the near future. This condition can progress through a spectrum of progressive liver damage to non alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis and liver cancer. Around 20-30% of NAFLD patients develop NASH, with a lower rate progressing further to fibrosis and cirrhosis. Currently, there is no approved pharmacological or interventional treatment for the management of this so prevalent disease, apart from changes in lifestyle aiming weight loss. The aim of the present pilot study is to assess the efficacy and safety of microbiota manipulation by means of Fecal Microbiota Transplantation in the treatment of patients with NASH.

NCT ID: NCT03801577 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Hepaxa Management of Non-alcoholic Fatty Liver Disease

Start date: February 2019
Phase: N/A
Study type: Interventional

This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.

NCT ID: NCT03796975 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease

Start date: June 28, 2018
Phase: Phase 4
Study type: Interventional

This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.

NCT ID: NCT03791203 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Non-Alcoholic Fatty Liver Disease

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

There is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. Currently, there are no studies had been focusing the effect of Modified Alternate Day Calorie Restriction in NAFLD patient focusing on changes in liver steatosis and fibrosis.

NCT ID: NCT03787108 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Measuring Fatty Liver With Ultrasound and MRS in Children With Overweight or Obesity

Start date: March 31, 2019
Phase:
Study type: Observational

Obesity is associated with a variety of comorbidities, amongst which non-alcoholic fatty liver disease (NAFLD). A recent meta-analysis has shown that the prevalence of NAFLD in obese pediatric populations is around 35%, compared to approximately 8% in general pediatric populations, making it a very important health threat in these populations. The golden standard for diagnosis of NAFLD is liver biopsy. However, since liver biopsy is associated with a certain risk of morbidity and mortality, this method is inappropriate for screening large populations at-risk for developing NAFLD. Magnetic resonance spectroscopy has demonstrated excellent correlation with liver biopsy and the is the most accuratete non-invasive method to measure liver fat content in children. However, MRS is expensive and not available in all centres. A novel ultrasonographic measurement to quantitatively assess liver steatosis is the hepatorenal index (HRI). Previous studies have shown high sensitivity and specificity of the HRI, as compared to MRS and liver biopsy. However, this measurement has never been validated in children. In this study, the HRI will be compared to MRS in children with obesity, to validate the HRI and to determine cut-off points.

NCT ID: NCT03786523 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Time Restricted Feeding on Nonalcoholic Fatty Liver Disease

TREATY-FLD
Start date: April 19, 2019
Phase: N/A
Study type: Interventional

Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).

NCT ID: NCT03784716 Completed - Liver Diseases Clinical Trials

Ketogenic Diet in Non-alcoholic Fatty Liver Disease

Start date: March 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this randomized trial is to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized to receive a ketogenic meal plan or control (standard weight loss meal plan). Participants will be followed up to 28 days after initiation of the diet intervention.

NCT ID: NCT03783897 Completed - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects

Start date: November 27, 2018
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects

NCT ID: NCT03776175 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease (NAFLD)

A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.

Start date: January 4, 2019
Phase: Phase 2
Study type: Interventional

This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In addition, this study will evaluate the safety and tolerability of co administration of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571 alone, and placebo in adults with NAFLD.

NCT ID: NCT03774511 Completed - Obesity Clinical Trials

Effects of Exercise on Patients With Nonalcoholic Fatty Liver Disease- A Comparative Randomized Controlled Trial

[PTREC]
Start date: July 9, 2017
Phase: N/A
Study type: Interventional

background: Obesity, diabetes mellitus type II and fatty liver disease combining with low levels of physical activity are prominent health risks for mortality and morbidity. More than 1/3 of the current population is suffering from obesity with a significant proportion to medical complications which can negatively influence their quality of life. These complications comprise alterations of the metabolism of glucose and fat, insulin resistance and diabetes mellitus. Objectives The purpose of this study was to compare between high intensity interval exercise and moderate intensity continuous on diabetic obese patients with NAFLD. Methods: forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention.