Clinical Trial: Role of Pioglitazone and Berberine in Treatment of Non-Alcoholic Fatty Liver Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Pioglitazone and Berberine in Treatment of Non-alcoholic Fatty Liver Disease(NAFLD) Patients With Impaired Glucose Regulation or Type 2 Diabetes Mellitus

Brief Summary: The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with impaired glucose regulation or type 2 diabetes mellitus.

Detailed Summary:

Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). NAFLD is a group of diseases with too much fat in liver in the absence of excess alcohol consumption. NAFLD encompasses a histological spectrum ranging from simple hepatic steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, and cirrhosis. NAFLD is estimated to affect 25% of the worldwide population[1] and 15.35% of adults in shanghai urban area[2]. Epidemiological data showed that the fatty liver may predict, independent of other factors, the metabolic syndrome, type 2 diabetes, and cardiovascular disease. Therefore, we may prevent those diseases by treating NAFLD.Life style intervention including activity and reducing energy intake is recommended by health care providers for optimal health and is the most common prescribed therapy for individuals diagnosed with NAFLD.

TZDs are oral glucose-lowering medications used to treat type 2 diabetes that enhance insulin sensitivity. The strong relationship between insulin resistance and NAFLD suggests that insulin sensitizing therapies such as TZDs might be beneficial in the prevention or improvement in NAFLD.TZDs bind to the peroxisome proliferator-activated receptors (PPARs), in part, by facilitating enhanced TG storage by adipocytes, suppressing the ectopic storage of lipids into liver and skeletal muscle. In addition, TZDs appear to have anti-inflammatory properties, inhibiting adipocyte gene expression and reducing circulating levels of TNFα[3] and resistin[4], and increasing adiponectin concentrations[5]. Some researches demonstrated that pioglitazone(a TZD) significantly reduced liver fat content of NAFLD, and ameliorated biological parameters and liver histology of NASH[6]. However, there have not been similar data of treating chinese NAFLD
Sponsor: Xin Gao

Current Primary Outcome: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) [ Time Frame: 16 weeks ]

improvement of the metabolic parameters, including serum glucose of OGTT, fasting glucose,2 hour glucose,area under the glucose curve and HbA1c,lipid profile（TC、TG、HDL-c、LDL-c、ApoA、ApoB、ApoE and Lpa），liver enzymes（ALT,AST,ALP,γ-GT）.


Original Primary Outcome: liver fat content by 1H NMR spectroscopy [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • liver fat content [ Time Frame: 16 weeks ]
    improvement of liver fat content by 1H NMR spectroscopy
  • serum insulin [ Time Frame: 16 weeks ]
    improvement of serum insulin including fasting insulin,2 hour insulin and area under insulin curve.
  • the ratio of withdrawing because of inefficiency [ Time Frame: 16 weeks ]


Original Secondary Outcome: OGTT(glucose, insulin, AUC of insulin)；liver enzymes(ALT、AST、γ-GT、ALP)；lipid profile（TC、TG、HDL-c、LDL-c、ApoA、ApoB、ApoE、Lpa）； [ Time Frame: 12 weeks ]

Information By: Fudan University

Dates:
Date Received: March 3, 2008
Date Started: March 2008
Date Completion:
Last Updated: June 3, 2012
Last Verified: June 2012