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Acute Viral HepatitisNCT00689546

Acute Viral Hepatitis and Diabetes Mellitus

An observational study of Acute Viral Hepatitis and Diabetes Mellitus, run by All India Institute of Medical Sciences at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Viral Hepatitis, Diabetes Mellitus
How many people
250 participants
Where
1 siteIndia
Study dates
Feb 2007to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • All patients between the ages of 18 to 70 years

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Subrat Acharya, DM contact

9868397200

subratacharya@yahoo.com

Kumar K Singh, MD contact

9868404908

kumarkirti73@yahoo.co.in

India1 site, 1 recruiting
  • All India Institute Of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

    Subrat Acharya, DM, 9868397200, subratacharya@yahoo.co.in

    Kumar K Singh, MD, 9868404908, kumarkirti73@yahoo.co.in

    Recruiting

Other trials in India

About this study

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

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.

Read the 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.

Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00689546
Study groupRoleWhat they receive
I/AAll cases of acute viral hepatitis irrespective of type (A, B, E) with underlying Type 2 diabetes mellitus
I/BAge 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/AAll diabetic who have acute icteric viral hepatitis due to HEV infection
II/BAge and sex matched diabetic who have acute icteric viral hepatitis due to hepatiits virus other than HEV.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of icteric hepatitis.

Secondary outcomes (2)
  1. Development of complications

  2. Mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2008 (estimated)
  2. Study startFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00689546
Sponsor's protocol ID
KKS-AVH-2008
Status last verified
Jan 2007
First submitted
30 May 2008
Last updated
3 Jun 2008
Results posted
No
Data monitoring committee
No

Publications

  • Hamid SS, Atiq M, Shehzad F, Yasmeen A, Nissa T, Salam A, Siddiqui A, Jafri W. Hepatitis E virus superinfection in patients with chronic liver disease. Hepatology. 2002 Aug;36(2):474-8. doi: 10.1053/jhep.2002.34856.

    PubMed 12143058
  • Monga R, Garg S, Tyagi P, Kumar N. Superimposed acute hepatitis E infection in patients with chronic liver disease. Indian J Gastroenterol. 2004 Mar-Apr;23(2):50-2.

    PubMed 15176535
  • Ramachandran J, Eapen CE, Kang G, Abraham P, Hubert DD, Kurian G, Hephzibah J, Mukhopadhya A, Chandy GM. Hepatitis E superinfection produces severe decompensation in patients with chronic liver disease. J Gastroenterol Hepatol. 2004 Feb;19(2):134-8. doi: 10.1111/j.1440-1746.2004.03188.x.

    PubMed 14731121
  • Vento S, Garofano T, Renzini C, Cainelli F, Casali F, Ghironzi G, Ferraro T, Concia E. Fulminant hepatitis associated with hepatitis A virus superinfection in patients with chronic hepatitis C. N Engl J Med. 1998 Jan 29;338(5):286-90. doi: 10.1056/NEJM199801293380503.

    PubMed 9445408
  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519
  • Behrns KE, Tsiotos GG, DeSouza NF, Krishna MK, Ludwig J, Nagorney DM. Hepatic steatosis as a potential risk factor for major hepatic resection. J Gastrointest Surg. 1998 May-Jun;2(3):292-8. doi: 10.1016/s1091-255x(98)80025-5.

    PubMed 9841987

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Viral Hepatitis and Diabetes Mellitus, run by All India Institute of Medical Sciences at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Subrat Acharya, DM (9868397200, subratacharya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of icteric hepatitis.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689546, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2008; AzTrials last refreshed its copy on 7 Nov 2026.

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