Diabetes Mellitus Clinical Trial
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.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |