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Fatty Liver clinical trials

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NCT ID: NCT02828579 Completed - Obesity Clinical Trials

The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

Start date: February 2015
Phase:
Study type: Observational

Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity. The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

NCT ID: NCT02826525 Completed - T2DM With NAFLD Clinical Trials

AZD4076 in Type 2 Diabetic Subjects With Non-Alcoholic Fatty Liver Disease.

Start date: July 18, 2016
Phase: Phase 1
Study type: Interventional

This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose study conducted at a single site. The study plans to include up to approximately 46 evaluable subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver disease (liver fat content > = 8%) on metformin monotherapy. Three initial cohorts are planned: - Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo - Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo - Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the possibility to add additional subjects if drop-out rates are higher than expected Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may be included in the study. The primary objectives of this clinical trial are to investigate the safety and tolerability of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp with tracer technique; and to assess the effect of AZD4076 on liver fat content using magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on 24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin resistant (HOMA-IR) and Matsuda index.

NCT ID: NCT02820285 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

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

Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions. The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.

NCT ID: NCT02816814 Enrolling by invitation - Metabolic Syndrome Clinical Trials

Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women

Start date: November 2016
Phase: N/A
Study type: Interventional

Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most common menopausal disorders and chronic diseases to which women are more exposed during this life stage. Therefore, menopausal women may represent a target for evaluating the effectiveness of nutritional intervention studies based on protective diets against the common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis. Lipidomics aims to study the lipid molecules in a "dynamic" way and allows to define not only structure and functions of a set of lipid species present in an organism, but also the changes that occur during cell metabolism under physiological and pathological conditions in order to understand their role as part of the complex functional balance of a living organism. Quantitative and qualitative determination of fatty acids profiles in cell membranes allows to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes, such as inflammation, stress, nutrition. Scientific evidence has shown that, for nutritional studies, the most representative cell is the erythrocyte, which is a biomarker of an individual's general state of health. In fact, the evaluation of the fatty acid composition contained in the membrane of red blood cell, which has an half-life of four months, allows to follow the nutritional status of a subject and to acquire information about his eating habits, with special reference to fat consumption. The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state which is often altered in patients with metabolic diseases, hepatic steatosis and obesity. Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years, will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical examination with blood pressure and anthropometric measurements (weight, height, waist and hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled will undergo medical examination and dietary control to assess the adherence to the dietary pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry after 4 and 16 weeks as well as blood samples after 16 weeks. The results will be analyzed using appropriate statistical tests. All patients will be made to sign an informed consent.

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: NCT02814240 Completed - Hepatic Steatosis Clinical Trials

Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging

SHAH
Start date: March 16, 2015
Phase: N/A
Study type: Interventional

The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.

NCT ID: NCT02808312 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function

Start date: July 13, 2016
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.

NCT ID: NCT02798861 Completed - Liver Disease Clinical Trials

Controlled Attenuation Parameter (CAP) in Liver Allografts

Start date: September 7, 2016
Phase:
Study type: Observational

The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.

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: NCT02787668 Completed - Insulin Resistance Clinical Trials

A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).