The Effect Of DAAs on miRNA-122 And Insulin Resistance In Chronic HCV Patients

NCT03687229 | Unknown

• 1 other identifier: miRNA-122 in chronic HCV
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The hepatitis C virus is a major cause of chronic liver diseases, including cirrhosis and hepatocellular carcinoma, and infects approximately 3 % of the world population (150-170 million). It is estimated that approximately 80 % of patients with acute hepatitis C fail to eliminate the virus and become chronically infected Hepatitis C virus infection is strongly associated with the dysregulation of glucose homoeostasis such as insulin resistance and type 2 diabetes. Despite these findings of insulin resistance development via direct effects on insulin signalling pathway, the complex relationship between intrahepatic Hepatitis C virus infection and extrahepatic insulin resistance remains elusive. One of the countries most affected by Hepatitis C virus is Egypt. The Egyptian Demographic and Health Surveys measured antibody prevalence among the adult population aged 15-59 years at 10.0% in 2015-substantially higher than global levels. Several micro ribonucleic acids have been determined to play a key role in regulating viral replication and pathogenesis during infection. micro ribonucleic acid-122 expression is enriched in the liver, accounting for approximately 70 % of the total micro ribonucleic acid population in normal adult hepatocytes. Moreover, a particularly intriguing function of micro ribonucleic acid-122 involves its role in the Hepatitis C virus replication cycle. Antagonism of micro ribonucleic acid-122 not only reduces viral replication but also reduces Hepatitis C virus propagation by decreasing the expression of enzymes involved in lipid metabolism, which can enhance Hepatitis C virus replication in cell culture models.

Conditions

Chronic Hepatitis c

Keywords

micro ribonucleic acid-122; insulin

Outcome Measures

Primary Outcomes (1)

• Percentage of change in the level of serum micro ribonucleic acid-122 in Chronic Hepatitis C patients

  Measure the level of micro ribonucleic acid-122 on the viral load of chronic hepatitis C patients treated with Sofosbuvir/Daclatasvir regimen using Real Time Polymerase Chain Reaction

  3 months

Study Arms (2)

Patient

Chronic HCV patients before treatment \& 3 months after starting of treatment. not known to be: 1. Cirrhosis 2. Diabetes Mellitus. 3. Hemochromatosis 4. HBV 5. HIV. 6. Hepatocellular carcinoma (HCC) 7. Chemotherapy 8. Organ transplantation

Diagnostic Test: A)microribonucleic acid-122(miRNA-122), B) Hepatitis C virus Real Time Polymerase chain Reaction (HCV RT-PCR); Diagnostic Test: A)fasting serum glucose, B)Fasting serum insulin

Control

Apparently healthy individuals

Diagnostic Test: A)microribonucleic acid-122(miRNA-122), B) Hepatitis C virus Real Time Polymerase chain Reaction (HCV RT-PCR); Diagnostic Test: A)fasting serum glucose, B)Fasting serum insulin

Interventions

A)microribonucleic acid-122(miRNA-122), B) Hepatitis C virus Real Time Polymerase chain Reaction (HCV RT-PCR) DIAGNOSTIC_TEST

measure level of serum micro ribonucleic acid -122 and insulin resistance in chronic hepatitis C patients using real time polymerase chain reaction

Control; Patient

A)fasting serum glucose, B)Fasting serum insulin DIAGNOSTIC_TEST

measure level of insulin resistance

Also known as: HOMA-IR scale

Control; Patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on chronic HCV patients attending the out patient AlRajhy Liver Institute Sovaldi Clinic who are not known to be diabetics

You may qualify if:

• Chronic HCV patients eligible for treatment with Direct Acting Antivirals.
• Chronic HCV patients 3 months after starting of treatment

You may not qualify if:

• Cirrhosis
• Diabetes Mellitus
• Hemochromatosis
• HBV
• HIV
• Hepatocellular carcinoma (HCC)
• Chemotherapy
• Organ transplantation

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Singhal A, Agrawal A, Ling J. Regulation of insulin resistance and type II diabetes by hepatitis C virus infection: A driver function of circulating miRNAs. J Cell Mol Med. 2018 Apr;22(4):2071-2085. doi: 10.1111/jcmm.13553. Epub 2018 Feb 7.

  PMID: 29411512 BACKGROUND

• Kouyoumjian SP, Chemaitelly H, Abu-Raddad LJ. Characterizing hepatitis C virus epidemiology in Egypt: systematic reviews, meta-analyses, and meta-regressions. Sci Rep. 2018 Jan 26;8(1):1661. doi: 10.1038/s41598-017-17936-4.

  PMID: 29374178 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Insulin Resistance

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Riham A Abdelmegid, MD

  Assiut University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neveen A Kamel, Professor.D

CONTACT

01227370776; kamel.neveen@yahoo.com

Seddik I Mohamed, Lecturer

CONTACT

01006578850; moh_ismail310@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigastor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 27, 2018

Record last verified: 2018-09