Liver Fibrosis and Steatosis in dm Non Invasive Evaluation

October 30, 2022 updated by: Mohamed adel mohamed hassan, Assiut University

Non Invasive Evaluation of Liver Fibrosis and Steatosis in Type 2 Diabetic Patient in Assiut University Hospitals

Non invasive evaluation of liver fibrosis and steatosis in type 2 diabetic patient in Assiut University hospitals

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Estimated incidences of non-alcoholic fatty liver disease (NAFLD) all over the world have increased twice in the last two decades, while the incidences of other chronic liver diseases (CLD) have remained unchanged or are on downward trends [LaBrecque ,et al2012]. Traditionally, NAFLD has been reported as a burden condition only in the United States (US) or Western countries. However, nowadays, urbanization has brought about sedentary lifestyles and overnutrition in many Arabian countries, leading to the increase of obesity and metabolic disorders. As the result, NAFLD has been very common . Currently, the population prevalence of NAFLD in the US and Europe is approximately 30 percent{Jian-Gao et al 2017,} Although almost all NAFLD patients have simple steatosis only, 10%20% of patients represent the active form: non-alcoholic steatohepatits (NASH) progressing to liver fibrosis, cirrhosis, heptatocellular carcinoma (HCC) and finally end-stage liver failure [LaBrecque,et al 2012].

NAFLD patients are at 64 times higher risk of cardiovascular disease(CVD), that include coronary artery disease and stroke, than patients without NAFLD [Targher,et al 2016]. Mortality in NAFLD patients is mostly due to CVD events, markedly exceeding the common population{Ekstedt, et al 2006} Type 2 diabetes mellitus (T2DM) is the main risk factor of NAFLD. Patients with T2DM are at a Greater risk of NAFLD and have a higher rate of death and progression to cirrhosis than non-diabetic Individuals [Younossi, et al 2004]. Therefore, screening for NAFLD and evaluating liver fibrosis in the diabetic population is extremely necessary for early detection and management, preventing the progression to advanced fibrosis, cirrhosis and HCC.

NAFLD is diagnosed when there is evidence of ≥ 5% hepatic steatosis either by histology or Imaging and absence of secondary causes of fatty accumulation [Chalasani,et al2018]. FibroScan can assess hepatic steatosis levels, This is a non-invasive, simple-to-perform imaging modality with high accuracy to assess liver stiffness and hepatic fat deposition. Thus far there has been little knowledge on the prevalence of NAFLD and liver fibrosis in diabetic populations in Egypt Therefore our study proposed to estimate the prevalence of NAFLD and the severity of Liver fibrosis by in T2DM patients with the use of fibroscan and other clinical and laboratory parameters.

Study Type

Observational

Enrollment (Anticipated)

60

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 Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Faculty of Medicine Assiut University
        • Contact:

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samle size was calculated using Epi- Info7, Based on prevelance of NAFLD and type 2 DM all patients In one year the minimum patients required for this study is 60 patient

Description

Inclusion Criteria:

  • Patients older than 18 years with known T2DM or previously unknown diabetes but displaying fasting glucose level of more than 126 mg/dl or HbA1c more than 6.5 % and who were admitted for medical check up, patient divided according to duration of DM to 3 groups less than 5 years from 5 to 10 years and more than 10 years

Exclusion Criteria:

- Patient with Alchole intake,causes of secondary hepatic steatosis abuse of steatogenic drugs(eg: amiodarone,valproic acid ,tetracycline) , positive HBs ag ,HCV ab, measurement failure( marked obesity,ascites,..) or unreliable results on Transient Elastography

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: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre specified group
Fibroscan Abdominal ultrasound Lab investigation
Radiation: Fibroscan
Liver fibroscan and ultrasonography
Other Names:
  • Abdominal ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver fibrosis and steatosis in type 2 diabetic patients
Time Frame: 1 year
our study proposed to estimate the prevalence of NAFLD and the severity of liver fibrosis in T2DM patients taking in account the duration of illness correlation of finding on fibroscan with abnormalities of lipogram and glycemic control finding.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Hossam Mahmoud Abdelwahab, PhD, Lecturer

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)

November 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

October 30, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

October 30, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liver fibrosis in dm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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