Clinical trial NCT05605717: Liver Fibrosis and Steatosis in dm Non Invasive Evaluation
Official title: Non Invasive Evaluation of Liver Fibrosis and Steatosis in Type 2 Diabetic Patient in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver fibrosis and steatosis in type 2 diabetic patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut university
Study officials:
affiliation: Lecturer
name: Hossam Mahmoud Abdelwahab, PhD
role: STUDY_CHAIR
References:
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