New NASH (Fatty Liver) Clinical Trials

2007-09-24T11:42:00.000-07:00

The Effect of a Probiotic on Hepatic Steatosis

Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome.

Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.
Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.
Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.
Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.

Metformin in Non-Alcoholic Fatty Liver Disease

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis (FLIRT)

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis.

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.

Treating Nonalcoholic Steatohepatitis With Pioglitazone

Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone at the NIH Clinical Center (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is stopped, however, ALT levels rapidly return to pre-treatment values. Inaddition we are currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks, however our results in 3 patients thus far have not been very encouraging.
In the current study, patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years. We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration. After a repeat medical and metabolic evaluation and liver biopsy, patients with moderate-to-severe NASH (activity score greater than or equal to 4) will restart pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or improved to the degree identified during the pilot study, the dose will be increased to 30 mg daily at the end of 3 years, all patients will undergo repeat medical and metabolic evaluation and liver biopsy. The primary end point will be improvement in liver histology. Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat, liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term pioglitazone therapy can safely achieve and maintain biochemical and histological improvements in NASH.

Related Books:
Fatty Liver Disease: NASH and Related Disorders
Related site: "Nashion" - Steatohepatitis Social Networking

Clinical Trials News

New NASH (Fatty Liver) Clinical Trials