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Fatty Liver clinical trials

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NCT ID: NCT02682173 Completed - Obesity Clinical Trials

Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver

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

Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

NCT ID: NCT02681055 Completed - Clinical trials for Hypercholesterolemia

Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects

Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.

NCT ID: NCT02679417 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease

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

The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.

NCT ID: NCT02670590 Completed - Fatty Liver Clinical Trials

NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

ct-NAFLD
Start date: January 2011
Phase: N/A
Study type: Interventional

Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90 ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

NCT ID: NCT02669641 Recruiting - Fatty Liver Clinical Trials

Complex Imaging Assessment of Steatosis

SteatoSPC
Start date: January 2016
Phase: Phase 4
Study type: Interventional

The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in patients diagnosed with hepatic steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline.

NCT ID: NCT02669316 Completed - Fatty Liver Clinical Trials

Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver

CARDIONAFLD
Start date: January 2008
Phase: N/A
Study type: Observational

NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An association of NAFLD with coronary artery disease and with impaired heart function was reported, but without considering severity of NAFLD and with the bias of including diabetes. Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score (BLS) can predict the impairment of systolic heart function, assessed by echocardiography (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass, Left atrial diameter.

NCT ID: NCT02663388 Recruiting - Obesity Clinical Trials

Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection)

OBESEPI
Start date: January 2016
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.

NCT ID: NCT02660047 Completed - Metabolic Syndrome Clinical Trials

Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients of South Asian Descent

MAGNA VICTORIA
Start date: August 2015
Phase: Phase 4
Study type: Interventional

Among South Asians, in comparison to Western Europeans, there is an increased risk of type 2 diabetes mellitus (DM2) and DM2-related cardiovascular disease. The effect of Liraglutide (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of South Asian descent specifically. Liraglutide is a new widely prescribed therapeutic agent for DM2 patients. It is a Glucagon Like Peptide - 1 homologue that improves glucose homeostasis and reduces blood pressure and body weight. The disadvantageous metabolic phenotype as seen in South Asians includes a relatively large total fat mass, with predominately visceral relative to subcutaneous adipose tissue and lower brown adipose tissue volume and activity, accompanied by increased lipid levels. The key elements in the mechanism of action of Liraglutide seem to correspond to the differences in metabolic profile between South Asians and Western Europeans. Diastolic dysfunction, an early finding of cardiovascular disease in DM2 and obesity and an independent predictor of mortality, has been shown to be associated with the amount of triglyceride accumulation in the heart and liver. The investigators hypothesize that Liraglutide has direct advantageous cardiovascular effects and reduces triglyceride accumulation in end-organs, specifically for DM2 patients of South Asian descent.

NCT ID: NCT02659553 Completed - Clinical trials for Post-operative Complications

Impact of Graft Steatosis on Post-operative Complications After Liver Transplantation

Start date: January 2015
Phase: N/A
Study type: Observational

1. Clinical impact of graft steatosis on postoperative complications after OLT. 2. Recommendations to improve outcomes after transplantation of steatotic livers and increase donor pool.

NCT ID: NCT02658786 Withdrawn - NAFLD Clinical Trials

Cost Effective Non Invasive Diagnostic Modalities and Predictive Model for Development and Progression of Fibrosis Among Patients With Hepatitis B, Hepatitis C Infection or Non Alcoholic Fatty Liver Disease

Start date: January 2016
Phase:
Study type: Observational

Chronic liver diseases of differing etiologies are among the leading causes of morbidity and mortality worldwide [1]. Chronic liver disease progresses through different pathological stages that vary from mild hepatic inflammation without fibrosis to advanced hepatic fibrosis and cirrhosis [2]. Assessment of the stage of liver disease is important for diagnosis, treatment, and follow-up both during treatment and after cessation of treatment. A liver biopsy is the oldest and most accurate method used to evaluate liver histology and the progression of chronic liver disease. Furthermore, different histological scoring systems have been developed and modified [3]. A liver biopsy is considered the gold standard for assessing liver histology [4]. During the pathological progression of liver fibrosis, excessive amounts of extracellular matrix build up; furthermore, serum levels of various biomarkers change, in addition to the appearance of new biomarkers in the serum during the different stages of fibrosis [2, 5]. Recently many noninvasive markers (NIMs) for assessing liver fibrosis have been developed, and they are frequently used in clinical practice. They have been validated in different studies, and some were found to be highly accurate in the assessment of liver fibrosis compared with liver biopsies [6-7], which have always been used as the standard reference method for evaluating the accuracy of noninvasive methods. There are limited studies documenting the cost effectiveness of non invasive markers over invasive technique. Most people with chronic Hepatitis B or C are unaware of their infection, putting them at serious risk of developing cirrhosis or liver cancer which are life threatening. Similarly patients with non alcoholic fatty liver diseases are unaware about fibrosis in liver. About 20-50% of persistent infection ends up into fibrosis and finally cirrhosis. Invasive and non invasive diagnostic methods are widely used to detect the fibrosis. Clinicians use different drugs and combinations to treat HBV and HCV infections. However, there is scarcity of a longitudinal prospective study to assess the cost effectiveness of these diagnostic measures. We planned to conduct a retrospective followed by prospective cohort study among all cases that underwent biopsy in ILBS or GB Pant Hospital since 2000 till Dec 2020 with HBV infection, HCV infection, or non alcoholic fatty liver disease. For retrospective cohort study, we will collect data from hospital information system for all patients with HBV infection, HCV infection, or non alcoholic fatty liver disease, who underwent biopsy during the period of 2000-Dec 2015. The new patients with HBV infection, HCV infection, or non alcoholic fatty liver disease who will undergo biopsy during the period Jan 2016- Dec 2020 will serve as a cohort for prospective design. We will collect socio-demographic data, clinical data, family history, personal history, medical history, anthropometry, biochemical and radiological data from each patient. We will also be conducting a cost effective analysis for various non invasive markers against biopsy as a gold standard in predicting fibrosis, both for retrospective and prospective cohorts. For prospective cohort study, after evaluation of baseline biopsy results, the cases with metavir fibrosis score (F0-3) will be followed for a period of 5 years to document incidence of development and progression of fibrosis. No additional investigation or test will be asked to the patient for the study. We will also develop a predicting model for development and progression of fibrosis.