Natural Course of Acute Icteric Viral Hepatitis in Type II Diabetes Mellitus Patients and Non-Diabetic Patients:A Pilot Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Duration of icteric hepatitis.
研究概览
简要总结
It has been observed that several of patients having prolonged or complicated course of acute viral hepatitis have underlying diabetes. It is possible that with impaired hepatocyte regenerating capacity, these patients run a more prolonged and complicated course.
We hypothesize that acute hepatitis infection has a prolonged and complicated course among diabetic patients.
详细描述
Acute viral hepatitis is usually a self limited condition characterizes by typical course of prodrome followed by an icteric phase. In some cases the course may be protracted or complicated by the development of cholestatic phase or acute liver failure . The development of complicated course depends on a number of factors such as the type of virus and a variety of host factors including age of infection, immune status of the host and condition of the underlying liver before the onset of hepatitis.
Patients who have an underlying chronic liver disease or cirrhosis have increased risk of development of decompensation and liver related death when they develop superinfection with some hepatotropic viruses.
Vento etal demonstrated in their classical study that superinfection with hepatitis A on chronic liver disease is associated with high risk of decompensation and death. In India, since most of the adult population including those with chronic liver disease has been shown to have protective antibodies against HAV, this infection is rarely a problem in them.
Hepatitis E virus (HEV) has demonstrated to be the most common cause of acute hepatitis, acute liver failure and subacute liver in India. There is now enough data to suggest that HEV superinfection is also the commonest cause of acute decompensation of chronic liver disease in Indian subcontinent.
Many of these patients do not have any signs and symptoms of preexisting liver disease and it is the liver failure secondary to HEV superinfection which bring to light the underlying chronic liver disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •All patients between the ages of 18 to 70 years
排除标准
- •Recent intake of drugs known to cause acute hepatitis
- •History of alcohol ingestion >40mg/day
- •Suspected ischemic hepatitis
- •Illness causing acute hepatitis such as Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia
- •Associated co morbidities, which can affect survival such as cardiovascular disease and diabetic nephropathy.
- •Recent intake of drugs known to cause acute hepatitis
- •History of alcohol ingestion >40mg/day
- •Suspected ischemic hepatitis
- •Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia
- •Co infection with HIV.
- •Comorbidities which affect survival such as CAD and diabetic nephropathy.
- •Gestational diabetes
- •Pregnant female
- •Cirrhosis
结局指标
主要结局
Duration of icteric hepatitis.
次要结局
- Development of complications
- Mortality
