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临床试验/NCT00687999
NCT00687999已完成不适用

Non-insulin-dependent Diabetes Mellitus and Insulin Resistance in Chronic Hepatitis C Patients Treated With Combination Therapy With Pegylated Interferon and Ribavirin in Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Sustained virological response (SVR) rate, HCV RNA seronegative by PCR throughout 24-week off-treatment period; biochemical, virological and histological characteristics of CHC patients; HOMA-IR change after combination therapy

研究概览

简要总结

The influence of insulin sensitivity and glucose tolerance on the effects of antiviral therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the clinical and virological factors associated with sustained viral response in patients with combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of combination therapy on HOMA IR

详细描述

Total 300 treatment-naïve chronic hepatitis C patients will be enrolled. The prevalence of NIDDM, IGT and IR will be explored in this hospital-based study among the clinically defined chronic hepatitis C Taiwanese. The clinical manifestations of chronic hepatitis C in the biochemical, virological and histopathological aspects will be evaluated. Liver enzymes will be measured on a multichannel autoanalyzer. Virological markers for HCV including serum HCV RNA detected using a standardized automated qualitative PCR assay, HCV RNA genotypes determined for genotypes 1a, 1b, 2a, 2b and 3a and serum HCV RNA levels measured by using the branched DNA assay. The liver histology will be assessed for scoring the disease activity grade quantitatively according to the histological activity index (HAI). Patients are assigned a diagnosis of DM if there was documented use of oral hypoglycemic medication or insulin, random glucose in excess of 200 mg/dL, or fasting glucose greater than 126 mg/dL on two occasions. A standard oral glucose tolerance test (OGTT) will be performed. In addition to an OGTT, a history of diabetes mellitus by chart review and/or questionnaire will be also obtained. Standard antiviral therapy will be carried out with PEG-IFN, given subcutaneously weekly plus 1,000-1,200 mg of oral ribavirin daily. Patients will receive another 24 week of follow-up period to determine the virological response.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic hepatitis C patients with positive anti-HCV for more than 6 months and HCV RNA
  • No overt hepatic failure or decompensated liver cirrhosis (Child-Pugh class B or C) or hepatocellular carcinoma.

排除标准

  • Positive for hepatitis B surface antigen (HBsAg)or with concomitant human immunodeficiency virus infection
  • With other types of hepatitis including autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, Wilson's disease, alpha 1-antitrypsin deficiency
  • Current or past history of alcohol abuse (80 mL ethanol per day)

研究组 & 干预措施

1

Other

干预措施: pegylated interferon alpha and ribavirin (Drug)

结局指标

主要结局

Sustained virological response (SVR) rate, HCV RNA seronegative by PCR throughout 24-week off-treatment period; biochemical, virological and histological characteristics of CHC patients; HOMA-IR change after combination therapy

时间窗: 18 months

次要结局

未报告次要终点

研究者

研究点 (1)

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