Micro RNA Levels in NAFLD

September 29, 2020 updated by: Nourhan Mahmoud Abbas, Assiut University

Hepatic Micro RNA Expression In Non Alcoholic Fatty Liver Disease

  • Epidemiological study of NAFLD, NASH patients.
  • Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis. - Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of hepatic steatosis (>5%-10% of hepatocytes are fatty) in people without history of excessive alcohol consumption (>21 drinks/week in men and > 14drinks/week in women) and other disease etiologies that result in fatty liver.

The presence of coexisting risk factors such as diabetes, metabolic syndrome, and obesity increases the risk of NAFLD. As a consequence of obesity pandemic and type 2 diabetes, an increased number of patients with NASH-the most severe form of NAFLD-is expected in the near future.

According to the latest epidemiological studies, the prevalence of NAFLD is approximately 25% worldwide.

In developed countries such as the United States, the prevalence of NAFLD is 30%. In developing countries such as China, the prevalence has reached up to 32.9%.

NAFLD comprises a spectrum of pathological conditions, Including simple steatosis (NAFL), nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis and hepatocellular carcinoma (HCC).

Studies have shown that approximately one-sixth of NAFL patients progress to NASH, and 20% of NASH patients can develop cirrhosis.

The traditional view suggests that HCC formation is a multi-stage process, involving inflammation, fibrosis and cirrhosis. However, recent research found that NASH can progress to HCC without fibrosis and cirrhosis.

NAFLD patients are often associated with higher risk of developing both cardiovascular disease and type 2diabetes, therefore early diagnosis of NAFLD and intervention would greatly benefit the patient by preventing the progression of major hepatic and extra hepatic manifestations.

In patients with NAFLD, the most important factor is the assessment of fibrosis severity and monitoring fibrosis progression. Most patients remain asymptomatic until their liver functionis compromised.

Thus, the identification of the presence and severity of liver fibrosis remains a clinical challenge.

Therefore, early predictors need to be investigated.

Multiple factors are involved in NAFLD development, including lipotoxicity, insulin resistance, endoplasmic reticulum stress, adipose tissue, gut microbiota, and genetics [9].

Our understanding of the pathogenesis of this disease remains limited because of its broad range and complexity.

Liver biopsy is the current gold standard in diagnosis and prognosis; nevertheless, it is an expensive and invasive procedure with high sampling error and risk of complications including pain bleeding; and, in very rare cases, death.

A biomarker is a patient characteristic assessed as an indicator of a normal or a pathologic process or of a biological response to treatment.

Unfortunately, to date, existing non- or minimally invasive biomarkers are inadequate.

Circulating extracellular vesicles (exosomes and ectosomes) contain various cellular molecules such as proteins, mRNA, miRNAs, and DNA can serve as biomarkers in NAFLD and NASH.

MicroRNAs (miRNAs) are short, non-coding single stranded RNAs strand of 20-25 nucleotides. miRNAs play complicated and important roles in regulating the expression of downstream genes .

MiRNAs contribute to the pathogenesis of NAFLD/NASH at various levels of disease development and progression and probably are the most extensively studied epigenetic modifications in NAFLD .

miR-122 is the most abundant miRNA in human liver, representing more than 70% of the total liver miRNA pool.

During hepatocytes maturation, miR-122 stimulates the expression of 24 hepatocytes-specific genes, including hepatocyte nuclear factor 6 (HNF6) [13], and in liver regeneration it has been reported to regulate hepatocytes proliferation and differentiation, recapitulating the developmental processes.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a hospital-based study will carried out prospectively in Tropical Medicine and Gastroenterology Department, Al-Rajhi Liver Hospital, Assiut University.

Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group cases and control).

cases : 40 patients of NAFLD patients with the previus eligibility criteria A control group : of 40 healthy age and sex-matched subjects with normal liver enzymes and abdominal ultrasonography findings

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Elevated aminotransferases
  3. Ultrasonographic presence of hyper echogenic liver
  4. fibroscan with a diagnosis of non-alcoholic fatty liver disease with fibrosis (NASH) without cirrhosis done no more than 6 months before the study.

Exclusion Criteria:

  1. A history of any level of alcohol consumption
  2. Any other form of chronic liver disease
  3. Use of any medications thought to cause or affect NAFLD
  4. Acute or chronic infection
  5. History of cancer
  6. Chronic kidney diseases

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptions of altered miRNA profiles in NAFLD patients especially with fibrosis.
Time Frame: baseline
Explore the role of circulating miRNAs as biomarkers for the early diagnosis and evaluation of NAFLD patient with fibrosis
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)

October 15, 2020

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • micro RNA in NAFLD

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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