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Nonalcoholic Steatohepatitis clinical trials

View clinical trials related to Nonalcoholic Steatohepatitis.

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NCT ID: NCT00590161 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Pentoxifylline in Patients With Nonalcoholic Steatohepatitis

Start date: December 2006
Phase: Phase 2
Study type: Interventional

One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year will result in improvement of biochemical parameters of liver disease and hepatic histology. The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and levels of cytokines in patients with NASH.

NCT ID: NCT00586911 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Betaine in Patients With Nonalcoholic Steatohepatitis

Start date: January 2003
Phase: Phase 2
Study type: Interventional

To assess the safety and efficacy of betaine in patients with NASH on markers of disease severity such as liver histology, liver biochemistries, and health related quality of life.

NCT ID: NCT00586885 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Effects of Alanine in Patients With Nonalcoholic Steatohepatitis

Start date: February 2004
Phase: N/A
Study type: Interventional

Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving biological and histological findings by administrating 6-18g/day L-alanine for one year. We will also assess the safety and toxicity profile of long-term administration of L-alanine.

NCT ID: NCT00586313 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)

NAFLD
Start date: January 2007
Phase: N/A
Study type: Interventional

Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and into the stomach to image various parts of the body. A small piece of tissue called a biopsy, of your liver nay be obtained by this method. the tissue (biopsy) would be obtained by inserting a small needle through the lining of the stomach into the liver. Consideration for this biopsy is because there may be extra fat stored within the liver. In some people who drink too much alcohol, extra fat may be stored in the liver, however, in some people who don't drink too much alcohol, this may also occur and is called :non-alcoholic fatty liver disease or NAFLD. Over time, this extra fat may lead to liver irritation and scar tissue called cirrhosis. If NAFLD is detected early enough, then treatment with medications, losing weight, or dietary changes may help avoid cirrhosis. the purpose of this study is to learn about whether doctors can obtain the biopsy from the liver by a new method. The biopsy of the liver allows the doctors to look for any signs of scar tissue or inflammation from any cause.

NCT ID: NCT00583999 Completed - Metabolic Syndrome Clinical Trials

The Role of Leptin Receptors in NASH

NASH
Start date: January 2006
Phase: N/A
Study type: Observational

NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD. Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD.

NCT ID: NCT00509418 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.

NCT ID: NCT00267670 Completed - Liver Diseases Clinical Trials

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

Start date: March 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

NCT ID: NCT00227110 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)

Start date: October 2002
Phase: Phase 4
Study type: Interventional

To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).

NCT ID: NCT00152711 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis

Start date: September 2004
Phase: N/A
Study type: Interventional

This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP) treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.

NCT ID: NCT00013598 Completed - Fatty Liver Clinical Trials

Treatment of Nonalcoholic Steatohepatitis With Pioglitazone

Start date: March 2001
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on decreasing insulin resistance and improving liver disease in patients with nonalcoholic steatohepatitis (NASH). NASH is a chronic liver disease with unknown cause that involves fat accumulation and inflammation in the liver, leading to liver cirrhosis in 10 to 15 percent of patients and significant liver scarring in another 30 percent. Although similar to a condition that affects people who drink excessive amounts of alcohol, NASH occurs in people who drink only minimal or no alcohol. It is most often seen in patients with insulin resistance. Pioglitazone decreases insulin resistance and improves blood lipid (fat) levels, so that it may improve liver disease in NASH. Patients with NASH 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history and physical examination and routine blood tests. They will see a dietitian for counseling on diet and weight reduction, if needed. They will stop taking any medications for liver disease and take a daily multivitamin pill. After 2 months, those eligible for participation will be enrolled in the study. Participants will be admitted to the Clinical Center for 2 to 3 days for a complete medical history, physical examination, blood tests, urinalysis, chest X-ray, electrocardiogram, abdominal ultrasound and a liver biopsy. After the diagnosis of NASH is confirmed, the following procedures will be performed: - Echocardiography - imaging test using sound waves shows the heart structure and function - Resting metabolic rate - measures amount of oxygen (and calories) used to maintain body functions at rest. While lying down, the patient wears a clear plastic hood over the head for 20 minutes while the amount of oxygen used is measured. - Magnetic resonance imaging (MRI) scans - shows the size of the liver and other organs. The patient lies on a table in a metal cylinder that contains a magnetic field (the scanner) for no more than 30 minutes while the organs are imaged. - Dual energy X-ray absorptiometry (DEXA) scan measures whole body composition, including amount of fat. The patient lies under an X-ray scanning machine for about 2 minutes. - Oral glucose tolerance test (OGTT) - measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected at various intervals during the 3-hour test. The blood is drawn through a catheter (thin plastic tube) placed in the arm before the test begins. - Intravenous glucose tolerance test (IVGTT) - determines how the tissues respond to insulin and glucose. Glucose is injected into a vein, followed by a short infusion of insulin. Blood samples are collected through a catheter at various intervals during the 3-hour test. When the above procedures are completed, patients start taking pioglitazone by mouth once a day for 48 weeks, keeping track of the medication and any side effects. They will be seen at the clinic every 2 weeks for the first month and then every 4 weeks for the rest of the treatment period. The visits will include an interview and examination by a physician and blood draw for laboratory tests. Female patients will have a pregnancy test at each clinic visit. At the end of the treatment period patients will be admitted to the Clinical Center for a repeat medical evaluation that will include the procedures described above.