Liver Fibrosis and Steatosis in dm Non Invasive Evaluation

Not yet recruiting

• Conditions: Liver Diseases
• Interventions: Radiation: Fibroscan

• Registration Number: NCT05605717
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-10-30
• Last Update Submitted: 2022-10-30
• Study Start: 2022-11-01
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre specified group	Fibroscan	Fibroscan Abdominal ultrasound Lab investigation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of medicine Assiut university; 🇪🇬 Assiut, Egypt