The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
研究概览
简要总结
Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis B virus patients with detectable viremia
- •>18 years old
- •signed a consent form
排除标准
- •patients with malignancy
- •Patients with diabetes mellitus
- •Alcohol consumption of more than 140grams a week
- •Advanced liver disease
- •HCV or HIV infection
- •Pregnancy
- •Mental retardation or unable to understand basic explanation about the study -
结局指标
主要结局
A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
时间窗: Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).
次要结局
未报告次要终点