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Steatosis clinical trials

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NCT ID: NCT06463223 Not yet recruiting - Metabolic Disease Clinical Trials

HIBOC = Hepatic Imaging Biomarkers in Obese Children

Start date: October 2024
Phase:
Study type: Observational

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

NCT ID: NCT05946330 Active, not recruiting - Liver Diseases Clinical Trials

Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).

NUTRINAFLD
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose. Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.

NCT ID: NCT03548597 Completed - Obesity Clinical Trials

Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery

Start date: April 4, 2012
Phase:
Study type: Observational

Background: The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients. Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery. Objectives: Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.

NCT ID: NCT02966899 Withdrawn - Clinical trials for Right Ventricular Failure

Reversal of Right Ventricular Steatosis in Pulmonary Hypertension

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

The goal of this study is to elucidate the relationship between myocardial right ventricular triglyceride content (steatosis) and right ventricular dysfunction in participants with pulmonary hypertension, and investigate reversibility of this phenotype with omega-3 fatty acid treatment.

NCT ID: NCT02621853 Not yet recruiting - Steatosis Clinical Trials

Clinical Validation of a Raman Spectroscope to Determine Hepatic Fat Content

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

Fatty liver disease including liver steatosis (fat deposition) is a major health problem worldwide. It is considered pathological when fat accumulation exceeds 5% of the liver weight. Transplantation represents the ultimate treatment for end stage liver disease. However, the discrepancy between the demand for donor organs and their availability presents one of the greatest hurdles of liver transplantation. Therefore, extended criteria organs have to be considered to overcome this shortcoming. Hepatic steatosis is one of the most important criteria defining extended-criteria donor liver. In liver transplantation, 'severe' fat deposition in donor liver is a major cause of graft failure while 'mild' deposition is considered transplantable and 'moderate' deposition represents the gray zone and remains difficult to assess. Surgeons usually perform a hepatic steatosis assessment during liver donor surgery. However, this method is very subjective and difficult especially when inexperienced surgeons or trainees are concerned. Furthermore, it has recently been documented that the assessment of steatosis is challenging even in the hands of experienced surgeons. Theoretically, a better way to assess steatosis before organ procurement would be a non-invasive imaging technique. However, some of these techniques appear to lack the sensitivity to accurately quantify hepatic fat content while others are complex, expensive and inconvenient to use in the setting of organ procurement. Therefore, liver biopsy remains the reference for grading hepatic steatosis. In daily practice the assessment and quantification of steatosis by a pathologist during organ procurement is more complex related to the lack of availability of dedicated hepatopathologists outside of office hours and in smaller community hospitals. A simple and short technique is therefore required to assess liver steatosis before retrieval. We have recently demonstrated that Raman spectroscopy could provide an accurate, rapid and real-time assessment of hepatic fat content and correlated highly with the gold standard (i.e. histopathological assessment of liver sections) in an animal model of liver steatosis. The purpose of this study is to validate the use of Raman spectroscopy for quantitative assessment of hepatic steatosis. In the hands of the surgeons this device can provide an immediate, robust tool to assess the suitability of donor livers at the site of retrieval prior to liver transplantation.

NCT ID: NCT02148471 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Fatty Acids, Genes and Microbiota in Fatty Liver

Start date: October 2003
Phase: N/A
Study type: Observational

The first aim of this study is to assess oxidative stress and nutritional status in patients with elevated liver enzymes who were found to have either simple steatosis (SS) or nonalcoholic steatohepatitis (NASH) or normal histological findings on liver biopsy by measuring liver lipid peroxides and tumor necrosis factor (TNF)-α, liver pathology and immunohistochemistry, liver function tests, liver and red blood cell membrane fatty composition, insulin resistance (IR) parameters, plasma lipid peroxides, plasma antioxidant vitamins and antioxidant power, lipid profile, subject demographics, medical history and medication use. The second aim is to detect differences in hepatic gene expression (messenger RNA, mRNA) and epigenetic regulation (micro RNA, miRNA) between patients with SS or NASH and healthy controls, in addition to determine in patients with non-alcoholic fatty liver disease (NAFLD = SS+NASH combined) whether there is an association between hepatic n-3 PUFA content and gene expression. The third aim is to determine the intestinal microbiome (microbial composition and metagenome) in patients with SS or NASH and healthy controls.

NCT ID: NCT01750021 Completed - Obesity Clinical Trials

Effects of Fat and Carbohydrates in Obese Men

FATFUNC
Start date: December 2012
Phase: N/A
Study type: Interventional

Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions. The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. The central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. Central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. The common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. It is therefore necessary to better understand the impact of the different macro-nutrients. The purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.

NCT ID: NCT01748682 Completed - Morbid Obesity Clinical Trials

Very Low Calorie Liquid Diet for Pre op Patients

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

Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. As there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack of robust evidence has made nutrition professionals adopt different procedures. There is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.

NCT ID: NCT00914446 Recruiting - Morbid Obesity Clinical Trials

Identification of Protective and Worsening Steatohepatitis (NASH) Factors

Start date: April 2008
Phase: N/A
Study type: Interventional

The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis.

NCT ID: NCT00742326 Terminated - HIV Clinical Trials

Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections

Start date: August 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that helps to reduce the body's resistance to insulin. It is approved by the Food and Drug Administration to treat diabetes. Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis. - Participants are randomly assigned to take either pioglitazone therapy or placebo for 48 weeks. This is followed by a second 48-week treatment period in which all participants take pioglitazone. - There are approximately 12 visits during the 96 weeks of the study. Participants will receive a physical assessment, blood and urine tests at each visit. In addition, periodic assessments of dietary habits, body composition, oral glucose tolerance testing, and health related quality of life questionnaires will be completed. - A repeat MRI of the liver is performed at 48 weeks and at the end of the study to evaluate any potential changes in liver fat and inflammation. In addition, there is a follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.