跳至主要内容
临床试验/NCT00689546
NCT00689546Unknown不适用

Natural Course of Acute Icteric Viral Hepatitis in Type II Diabetes Mellitus Patients and Non-Diabetic Patients:A Pilot Cohort Study

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年2月最近更新:
适应症

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

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

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other

研究点 (1)

Loading locations...

相似试验