Liver Fibrosis and Steatosis in dm Non Invasive Evaluation

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05605717
Collaborator
(none)
60
1
10
6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Fibroscan

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Non Invasive Evaluation of Liver Fibrosis and Steatosis in Type 2 Diabetic Patient in Assiut University Hospitals
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pre specified group

Fibroscan Abdominal ultrasound Lab investigation

Radiation: Fibroscan
Liver fibroscan and ultrasonography
Other Names:
  • Abdominal ultrasound
  • Outcome Measures

    Primary Outcome Measures

    1. Liver fibrosis and steatosis in type 2 diabetic patients [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine Assiut university Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Hossam Mahmoud Abdelwahab, PhD, Lecturer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed adel mohamed hassan, Resident, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05605717
    Other Study ID Numbers:
    • Liver fibrosis in dm
    First Posted:
    Nov 4, 2022
    Last Update Posted:
    Nov 4, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2022