Micro RNA Levels in NAFLD

NCT04574557 | Unknown

• 1 other identifier: micro RNA in NAFLD
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

micro RNA

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Interventions

micro RNA DIAGNOSTIC_TEST

miRNA was isolated from serum using a miRNeasy Mini Kit (Qiagen, Cat; 217004)cDNA was isolated from obtained miRNA samples using a miScript Reverse Transcription Kit (Qiagen, Cat; 218060) Quantitative Real-Time PCR (qPCR) will be done using (miScript SYBR Green PCR Kit Qiagen Cat. No: 218073)The qPCR assays were performed in duplicate The relative expressions of Three miRNAs were selected for RT-PCR validation Two were selected from over-expressed miRNAs (miR-34a, miR-146b), one from under-expressed miRNAs (miR-122) were analyzed using the standard 2-ΔΔCT method. These miRNAs were selected due to their pathophysiological relation with NASH. Predicted gene targets of all differentially expressed miRNAs will be identified. Genes with functions that are potentially relevant to the pathogenesis of NASH and gene targets that are commonly studied e.g. lipogenesis (e.g. FAS), inflammation (c-JUN kinase) will be included in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• A history of any level of alcohol consumption
• Any other form of chronic liver disease
• Use of any medications thought to cause or affect NAFLD
• Acute or chronic infection
• History of cancer
• Chronic kidney diseases

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Dodds WJ, Hogan WJ, Miller WN. Reflux esophagitis. Am J Dig Dis. 1976 Jan;21(1):49-67. doi: 10.1007/BF01074140. No abstract available.

  PMID: 3966 BACKGROUND

• Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.

  PMID: 26707365 BACKGROUND

• Cotter TG, Rinella M. Nonalcoholic Fatty Liver Disease 2020: The State of the Disease. Gastroenterology. 2020 May;158(7):1851-1864. doi: 10.1053/j.gastro.2020.01.052. Epub 2020 Feb 13.

  PMID: 32061595 BACKGROUND

• Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.

  PMID: 32012320 BACKGROUND

• Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.

  PMID: 16012941 BACKGROUND

• Febbraio MA, Reibe S, Shalapour S, Ooi GJ, Watt MJ, Karin M. Preclinical Models for Studying NASH-Driven HCC: How Useful Are They? Cell Metab. 2019 Jan 8;29(1):18-26. doi: 10.1016/j.cmet.2018.10.012. Epub 2018 Nov 15.

  PMID: 30449681 BACKGROUND

• Baffy G, Brunt EM, Caldwell SH. Hepatocellular carcinoma in non-alcoholic fatty liver disease: an emerging menace. J Hepatol. 2012 Jun;56(6):1384-91. doi: 10.1016/j.jhep.2011.10.027. Epub 2012 Feb 9.

  PMID: 22326465 BACKGROUND

• Anstee QM, Targher G, Day CP. Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):330-44. doi: 10.1038/nrgastro.2013.41. Epub 2013 Mar 19.

  PMID: 23507799 BACKGROUND

• Baranova A, Younossi ZM. The future is around the corner: Noninvasive diagnosis of progressive nonalcoholic steatohepatitis. Hepatology. 2008 Feb;47(2):373-5. doi: 10.1002/hep.22140. No abstract available.

  PMID: 18220279 BACKGROUND

• Than NN, Newsome PN. A concise review of non-alcoholic fatty liver disease. Atherosclerosis. 2015 Mar;239(1):192-202. doi: 10.1016/j.atherosclerosis.2015.01.001. Epub 2015 Jan 13.

  PMID: 25617860 BACKGROUND

• Malhi H. Emerging role of extracellular vesicles in liver diseases. Am J Physiol Gastrointest Liver Physiol. 2019 Nov 1;317(5):G739-G749. doi: 10.1152/ajpgi.00183.2019. Epub 2019 Sep 23.

  PMID: 31545919 BACKGROUND

• Xiao G, Zhu S, Xiao X, Yan L, Yang J, Wu G. Comparison of laboratory tests, ultrasound, or magnetic resonance elastography to detect fibrosis in patients with nonalcoholic fatty liver disease: A meta-analysis. Hepatology. 2017 Nov;66(5):1486-1501. doi: 10.1002/hep.29302. Epub 2017 Sep 26.

  PMID: 28586172 BACKGROUND

• Pu K, Wang Y, Bai S, Wei H, Zhou Y, Fan J, Qiao L. Diagnostic accuracy of controlled attenuation parameter (CAP) as a non-invasive test for steatosis in suspected non-alcoholic fatty liver disease: a systematic review and meta-analysis. BMC Gastroenterol. 2019 Apr 8;19(1):51. doi: 10.1186/s12876-019-0961-9.

  PMID: 30961539 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

miRNA was isolated from serum using a miRNeasy Mini Kit (Qiagen, Cat; 217004) cDNA was isolated from obtained miRNA samples using a miScript Reverse Transcription Kit (Qiagen, Cat; 218060) Quantitative Real-Time PCR (qPCR) will be done using (miScript SYBR Green PCR Kit Qiagen Cat. No: 218073)The qPCR assays were performed in duplicate The relative expressions of Three miRNAs were selected for RT-PCR validation Two were selected from over-expressed miRNAs (miR-34a, miR-146b), one from under-expressed miRNAs (miR-122) were analyzed using the standard 2-ΔΔCT method. These miRNAs were selected due to their pathophysiological relation with NASH. Predicted gene targets of all differentially expressed miRNAs will be identified. Genes with functions that are potentially relevant to the pathogenesis of NASH and gene targets that are commonly studied e.g. lipogenesis (e.g. FAS), inflammation (c-JUN kinase) will be included in the study.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Nourhan M.Abbas, master

CONTACT

01027408731; nourmahmoud845@yahoo.com

sahar M.Hassany, MD

CONTACT

01007314122; saharhassany@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at tropical medicine and gastroenterology department

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 15, 2020
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 5, 2020

Record last verified: 2020-09