The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study
研究概览
简要总结
The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give written consent
- •HCV RNA PCR positive for 6 months
- •Normal Hgb, WBC,Neutrophils
- •Platelets of >/= 65,000
- •Direct Bili, within 20% ULN
- •Albumin >3
- •Serum Creatinine <20% ULN
- •AFP </= 100
排除标准
- •Women who are pregnant or breast-feeding
- •No Thiazolidinedione, Metformin,unless required for the treatment of type II DM
- •Hepatitis C of non-genotype 1,2,3
- •Any other cause for liver disease other than chronic hepatitis C
- •Hemoglobinopathies
- •Evidence of advanced liver disease
- •Previous organ transplant
- •Severe psychiatric disorder
- •Significant cardiovascular dysfunction within the past 12 months
- •Poorly controlled diabetes mellitus
- •Immunologically mediated disease
- •Any medical condition requiring chronic systemic administration of steroids
- •Evidence of an active or suspected cancer
- •Substance abuse at the time of the study
- •Known HIV
- •Irritability or unwillingness to provide informed consent
研究组 & 干预措施
1
one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
干预措施: N-acetylcysteine 20% 4ml (Drug)
1
one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
干预措施: N-acetylcysteine 20% in 4 ml (Drug)
结局指标
主要结局
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study
时间窗: 2 years
次要结局
- One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels(2 years)
研究者
Prashant Pandya
Principal Investigator
Kansas City Veteran Affairs Medical Center