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.
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.
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- 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.
India1 site, 1 recruiting
- 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
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.
- Conditions
- Acute Viral Hepatitis, Diabetes Mellitus
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of icteric hepatitis.
Secondary outcomes (2)
Development of complications
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Viral HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Subrat Acharya, DM, Principal investigator, All India Institiute Of Medical Sciences
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 12143058Monga 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 15176535Ramachandran 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 14731121Vento 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 9445408Wild 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 15111519Behrns 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course of Acute Icteric Viral Hepatitis in Type II Diabetes Mellitus Patients and Non-Diabetic Patients:A Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT00689546
- Acronym / sponsor ID
- KKS-AVH-2008
- Conditions
- Acute Viral Hepatitis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2007
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All patients between the ages of 18 to 70 years
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of icteric hepatitis.
2 secondary outcomes
Development of complications
Mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
- Background: PubMed 12143058Hamid 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.
- Background: PubMed 15176535Monga 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.
- Background: PubMed 14731121Ramachandran 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.
- Background: PubMed 9445408Vento 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.
- Background: PubMed 15111519Wild 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.
- Background: PubMed 9841987Behrns 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subrat Acharya, DM principal investigator
All India Institiute Of Medical Sciences
1 site in 1 country: see every site and its status.
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.