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Fatty Liver clinical trials

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NCT ID: NCT03198572 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

EASYBEinNASH
Start date: August 16, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.

NCT ID: NCT03198104 Completed - Liver Diseases Clinical Trials

Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI

Kids4LIFe
Start date: April 1, 2016
Phase:
Study type: Observational

This is a prospective observational study which will recruit up to 100 paediatric participants over a period of 30 months to determine whether MRI is as accurate at detecting, distinguishing, and monitoring liver disease as current standard of care techniques such as liver biopsy and fibroscan.

NCT ID: NCT03193177 Completed - Chronic Disease Clinical Trials

A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

Start date: June 20, 2017
Phase:
Study type: Observational

Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to treat metabolic and autoimmune diseases in mice. However, clinical trials performing prolonged fasting with more than 7 days have not been reported. Investigators conduct an open label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day fasting-like diet in the treatment of metabolic and autoimmune diseases.

NCT ID: NCT03190538 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis in Chinese Children

Start date: May 1, 2017
Phase:
Study type: Observational

Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality. A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.

NCT ID: NCT03186859 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)

EDISON
Start date: June 9, 2017
Phase: N/A
Study type: Interventional

Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure. NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors. This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Participants will have ten study visits, four of which may be combined with NHS appointments. Participants will undergo investigations including MRI scans to measure changes in NAFLD and DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. In addition to samples taken as part of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. Visits will take place before and after low calorie diet and bariatric surgery.

NCT ID: NCT03184376 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Histological Improvement of NASH With Prebiotic

Start date: February 28, 2012
Phase: N/A
Study type: Interventional

This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8 g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary outcome measure is the change in liver biopsy NAS score and the secondary outcomes include changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory markers, and gut microbiota.

NCT ID: NCT03183193 Recruiting - Overweight Clinical Trials

Fatty Liver in Obesity: Long-lifestyle Follow-up (FLiO)

FLiO
Start date: June 2016
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid accumulation in subjects that consume less than 20g ethanol per day, without other known causes as drugs consumption or toxins exposure. In Western countries, the rate of this disease lies about 30% in the general adult population. The process of developing NAFLD can start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy is considered the "gold standard" of steatosis, fibrosis and cirrhosis. However, it is rarely performed because it is an invasive procedure and investigators are focusing in the application of non-invasive liver damage scores for diagnosis. The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as unbalanced diets and overnutrition as well as by lack of physical activity in the context of a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle modifications. Weight loss, exercise and healthy eating habits are the main tools to fight NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are necessary. With this background, the general aim of this project is to increase the knowledge on the influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in future obese people.

NCT ID: NCT03179657 Active, not recruiting - Obesity Clinical Trials

Guangzhou Nutrition and Health Study (GNHS)

GNHS
Start date: July 1, 2008
Phase:
Study type: Observational

Purpose: The Guangzhou Nutrition and Health Study (GNHS) project aims to assess the determinants of metabolic disease in nutritional aspects, as well as other environmental and genetic factors, and explore possible mechanisms with multi-omics integration. Study design: GNHS is a community-based prospective cohort study. Participants: In this cohort, the original GNHS and another cohort study (the controls of a case-control study of hip fractures, CCFH) have been integrated into the one GNHS project. After completing the baseline examination, a total of 5118 participants were recruited during 2008-2015 in the GNHS project. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, dual-energy x-ray absorptiometry (DXA) scanning, ultrasonography evaluation, vascular endothelial function evaluation, cardiopulmonary exercise testing, magnetic resonance imaging (MRI), 14-d real-time continuous glucose monitoring tests, laboratory tests, and multi-omics data were/will be conducted. Up to December 2022, 3442 and 2895 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, muscle function and bracelet motion monitoring. 3. DXA scanning: To determine bone density, bone mineral content, bone geometry information, fat mass, and muscle mass. 4. Ultrasonography evaluations: To determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Vascular endothelial function evaluation. 6. Cardiopulmonary exercise testing: Lung function. 7. MRI: Brain and upper-abdomen MRI. 8. 14-d Real-time continuous glucose monitoring tests. 9. Specimen collections: Overnight fasting blood, early morning first-void urine, faces, and saliva samples. 10. Laboratory tests: Metabolic syndrome-related indices; Diabetes-related indices; Uric acid; Nutritional indices; Inflammatory cytokines; Index of oxidative stress; Adipocytes; Sexual hormones; Liver and renal function-related markers; Routine blood test. 11. Multi-omics data: Genotyping data; Gut microbiota; Untargeted serum and fecal proteomics; Targeted serum and fecal metabolomics. 12. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.

NCT ID: NCT03172650 Recruiting - Liver Diseases Clinical Trials

Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions

Start date: July 1, 2017
Phase: N/A
Study type: Observational

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.

NCT ID: NCT03166735 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH

Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.