Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene

February 2, 2019 updated by: Reham I El-mahdy, Assiut University
Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a benign disease, it often progresses to a serious state, and mortality is still high. Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main differential diagnosis is pancreatic cancer, which can be ruled out through radiological, serological, and histological investigations.

Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100% but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.

VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining normal insulin levels in accordance to glucose concentrations and to maintain glucose tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality, e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on the balance in the vitamin D concentration in the circulation, and the final metabolite activity throughout the body.

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute pancreatitis

Description

Inclusion Criteria:

  • Patients with a confirmed diagnosis of acute pancreatitis.
  • Patients of age 20 years or more who are willing to participate in the study and give their consent for same.

Exclusion Criteria:

  • with a history of severe liver disease,
  • sepsis
  • Chest disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I:
Seventy patients with pancreatitis
Genetic: Measurement of VDR genetic polymorphism
VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.
Group II:
Thirty healthy controls
Genetic: Measurement of VDR genetic polymorphism
VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls
Time Frame: Baseline
Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 20, 2019

Study Registration Dates

First Submitted

February 2, 2019

First Submitted That Met QC Criteria

February 2, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 2, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autoimmune pancreatitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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