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Fatty Liver clinical trials

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NCT ID: NCT01277237 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

Start date: September 2010
Phase: Phase 3
Study type: Interventional

There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.

NCT ID: NCT01277094 Completed - Clinical trials for Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

Start date: April 2011
Phase: Phase 1
Study type: Interventional

This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.

NCT ID: NCT01265498 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)

FLINT
Start date: March 2011
Phase: Phase 2
Study type: Interventional

Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).

NCT ID: NCT01264198 Completed - Resistance Training Clinical Trials

The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

Start date: December 2010
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

NCT ID: NCT01262326 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Determination of the Effect of Extreme Dietary Carbohydrate Restriction on Hepatic Glucose Production

Start date: January 2005
Phase: N/A
Study type: Interventional

All subjects will be evaluated by the Research Nurse at the Clinical Translational Research Center (CTRC) Outpatient Clinic to obtain informed consent, a brief medical history, weight, body mass index, waist/hip circumference and vital signs. Additionally, blood will be drawn at this visit to screen for renal dysfunction (Chem 10), liver disease (liver function tests (LFT's)), thyroid dysfunction (TSH), diabetes mellitus (HbA1C), and chronic inflammatory states (erythrocyte sedimentation rate). Subjects recruited to the study will be placed on a low-carbohydrate diet (<20 g/d without caloric restriction) designed either to promote weight loss or maintain weight stability for fourteen days prior to the protocol or they will consume a typical "Western" diet designed either to promote weight loss (restricted by 1300 kcal/d in the final fourteen days) or maintain weight stability for twenty-one days. Subjects recruited to the study will be lean, overweight, or obese and also may carry a diagnosis of NAFLD. Target accrual for total enrollment for this project will be set to 80 subjects to accommodate attrition and screen failures. The details of the low-carbohydrate diet have been discussed in consultation with Linda Brinkley, nutrition staff of the CTRC. Subjects chosen to undergo carbohydrate-restriction will have a teaching session with a CTRC dietician. Subjects will then initiate dietary carbohydrate-restriction on their own and keep a daily dietary record for seven days. At the end of seven days, the dietary record will be analyzed. The CTRC will then prepare all meals for the final seven days of the diet in accordance with daily caloric intake calculated from the dietary record. Calorie-restricted participants will keep a dietary record for one week while eating a typical "Western" diet. The dietician will analyze this record and meals restricted by 1300 kcal/d will be prepared by the CTRC for the final fourteen days of the diet. Alternatively, some subjects eating a typical "Western" diet may consume prepared meals with a fixed content of carbohydrate, fat, and protein that is unrelated to their pre-study dietary intake. In this scenario, the dietary carbohydrate content may be varied between 30 and 60% to provide information on differences in hepatic metabolism under conditions of differing, but clinically sustainable, carbohydrate intake. All participants will be admitted to the CTRC the night prior to the study and begin an overnight fast after dinner. Between 18:00 and 09:00, subjects will receive two stable isotope tracers orally: [U-13C]propionate at 08:00 (three 400 mg doses given over 1 hour) and 70% 2H2O at 22:00, 02:00, and 06:00. During the study subjects will also be given 0.5% 2H2O ad libitum. Two 500 mg acetaminophen tablets will also be given at 08:00. Between 08:00 and 09:00 subjects will undergo measurement of their respiratory quotient (RQ) using the CTRC indirect calorimeter (Delta Trac II).. Subjects will then have an intravenous catheter placed and an infusion of tracer amounts of [3,4-13C2]glucose, [1,2-13C]β-hydroxybutyrate and [3,4-13C]acetoacetate will be initiated. At 1 ½ and 2 hours after initiation of the infusion, a 50 cc blood draw will be performed. Voided urine will be collected every hour after ingestion of acetaminophen until the protocol concludes. The subject will then be given a meal and discharged from the CTRC, marking the completion of the protocol. The collected blood and urine will be transported by the research coordinator to the Advanced Imaging Research Center lab for analysis by MRS. Another blood draw (approximately 10 cc) will be done in conjunction with the final MRI in order to measure changes in the lipid profile after the diet intervention. The visits in their entirety will be as follows: 1 screening visit: 20 minutes 1. dietician visit: 20 minutes 2. MRS visits: 45 minutes each 1 (optional) overnight visit: 20 hours

NCT ID: NCT01257685 Completed - Insulin Resistance Clinical Trials

Selenoprotein P and Non-alcoholic Fatty Liver Disease

Start date: September 2007
Phase:
Study type: Observational

The pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. The most widely supported theory implicates insulin resistance as the key mechanism leading to hepatic steatosis, and perhaps also to steatohepatitis. Selenoprotein P(SeP) is a secretory protein primarily produced by the liver. Previous studies demonstrated that SeP, a liver-derived secretory protein, causes insulin resistance. Therefore, the purpose of this study is to determine the different Sep levels between healthy normal group and NAFLD group.

NCT ID: NCT01237119 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

LEAN
Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether 48 weeks treatment with once-daily injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough to warrant further investigation.

NCT ID: NCT01234714 Completed - Surgery Clinical Trials

Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications

MRsteatosis
Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with post-operative complications.

NCT ID: NCT01210989 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis

Start date: May 2010
Phase: N/A
Study type: Interventional

Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a progressive course and may result in liver cirrhosis and liver cancer. However, there is yet proven treatment for this disorder. In cell line and animal studies, we have shown that Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the efficacy in NASH has not been confirmed in humans. This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy. Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be further analyzed.

NCT ID: NCT01208649 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

Effects of Exenatide (Byetta®) on Liver Function in Patients With Nonalcoholic Steatohepatitis (NASH)

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

The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning), summarized in the recently introduced NASH-score in patients with normal, impaired or diabetic glucose tolerance compared to dietary guidance alone.