Acute Viral Hepatitis and Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00689546
First received: May 30, 2008
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition
Acute Viral Hepatitis
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Natural Course of Acute Icteric Viral Hepatitis in Type II Diabetes Mellitus Patients and Non-Diabetic Patients:A Pilot Cohort Study

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Duration of icteric hepatitis. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of complications [ Designated as safety issue: No ]
  • Mortality [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2007
Groups/Cohorts
I/A
All cases of acute viral hepatitis irrespective of type (A, B, E) with underlying Type 2 diabetes mellitus
I/B
Age and sex matched non- diabetic patients with acute viral hepatitis (irrespective of type) recruited from all the patients of acute viral hepatitis registered during the time period in which cases were recruited.
II/A
All diabetic who have acute icteric viral hepatitis due to HEV infection
II/B
Age and sex matched diabetic who have acute icteric viral hepatitis due to hepatiits virus other than HEV.

Detailed Description:

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.

World over, as well as in developing countries nonalcoholic fatty liver disease (NAFLD) is fast emerging as an important causes of chronic liver disease. Obesity and diabetes are two most important risk factors for NAFLD.It has been estimated that there would be about 366 million diabetes in the world by 2030.Of these 79.4 million will be in India.

Diabetes has been proposed as a risk factor for both chronic liver disease and HCC.The spectrum of liver involvement ranges from fatty liver, steatohepatitis, and fibrosis to cirrhosis. Even among patients with NASH, presence of diabetes is annotated with advanced stage of fibrosis . There is some suggestion that diabetic patients who develop acute viral hepatitis may have a prolonged course. Liver regeneration capacity has been demonstrated to be impaired among animal and human with fatty liver after partial resection. It is therefore possible that diabetic by of having NAFLD may have poor regenerating capacity leading to prolonged course of hepatitis.

It has been an observation in our unit that most of the patients who present with acute on chronic liver failure or subacute hepatic failure have diabetes. Whether it is simply a co-existence of two commonly occurring diseases (diabetes with a prevalence of 10% in Indian population and hepatitis E which is endemic(1) in our country) or the presence of acute hepatitis E in a diabetic patients some how produces a worse outcome as compared to hepatitis E in a non-diabetic patients. There fore it is important to find out the natural course of the two commonly occurring diseases when they occur together or separately.

We hypothesize that acute hepatitis infection has a prolonged and complicated course among diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients of acute viral hepatitis attending the OPD of Department of Gastroenterology and Endocrinology, All India Institute of Medical Sciences (AIIMS) will be candidates for the inclusion in the study.

Criteria

Inclusion Criteria:

  • All patients between the ages of 18 to 70 years

Exclusion Criteria:

  • 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
  • HIV.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689546

Contacts
Contact: Subrat Acharya, DM 9868397200 subratacharya@yahoo.com
Contact: Kumar K Singh, MD 9868404908 kumarkirti73@yahoo.co.in

Locations
India
All India Institute Of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Subrat Acharya, DM    9868397200    subratacharya@yahoo.co.in   
Contact: Kumar K Singh, MD    9868404908    kumarkirti73@yahoo.co.in   
Sub-Investigator: Kumar K Singh, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Subrat Acharya, DM All India Institiute Of Medical Sciences
  More Information

Publications:
Responsible Party: S K Acharya, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00689546     History of Changes
Other Study ID Numbers: KKS-AVH-2008
Study First Received: May 30, 2008
Last Updated: May 30, 2008
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Hepatitis
Hepatitis A
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on October 01, 2014