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

Acute Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03830073
• Other study ID #: Autoimmune pancreatitis
• Status: Not yet recruiting
• Start date: March 1, 2019
• Est. completion date: June 20, 2019

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: reham elmahdy
• Phone: +201002714637
• Email: reham.elmahdy[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 20, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Disease Susceptibility
• Pancreatitis

Intervention

Genetic:
• Measurement of VDR genetic polymorphism
VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Chan A, Bazerbachi F, Hanson B, Alraies MC, Duran-Nelson A. Cytomegalovirus hepatitis and pancreatitis in the immunocompetent. Ochsner J. 2014 Summer;14(2):295-9. — View Citation

Cieslinska A, Kostyra E, Fiedorowicz E, Snarska J, Kordulewska N, Kiper K, Savelkoul HFJ. Single Nucleotide Polymorphisms in the Vitamin D Receptor Gene (VDR) May Have an Impact on Acute Pancreatitis (AP) Development: A Prospective Study in Populations of AP Patients and Alcohol-Abuse Controls. Int J Mol Sci. 2018 Jun 29;19(7). pii: E1919. doi: 10.3390/ijms19071919. — View Citation

Ozsvár Z, Deák J, Pap A. Possible role of Coxsackie-B virus infection in pancreatitis. Int J Pancreatol. 1992 Apr;11(2):105-8. — View Citation

Shimizu K, Tahara J, Takayama Y, Akao J, Ajihara T, Nagao K, Shiratori K, Tokushige K. Assessment of the Rate of Decrease in Serum IgG4 Level of Autoimmune Pancreatitis Patients in Response to Initial Steroid Therapy as a Predictor of Subsequent Relapse. Pancreas. 2016 Oct;45(9):1341-6. doi: 10.1097/MPA.0000000000000633. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls	Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.	Baseline