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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03830073

Collaborator

(none)

100

Enrollment

3.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis	Genetic: Measurement of VDR genetic polymorphism

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 20, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls [Baseline]
Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.