Liver Fibrosis and Steatosis in dm Non Invasive Evaluation

NCT ID: NCT05605717

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-09-01

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.

Conditions

Liver Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pre specified group

Fibroscan Abdominal ultrasound Lab investigation

Fibroscan

Intervention Type: RADIATION

Liver fibroscan and ultrasonography

Interventions

Fibroscan

Liver fibroscan and ultrasonography

Intervention Type: RADIATION

Other Intervention Names

Abdominal ultrasound

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed adel mohamed hassan

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hossam Mahmoud Abdelwahab, PhD

Role: STUDY_CHAIR

Lecturer

Locations

Faculty of medicine Assiut university

Asyut, , Egypt

Countries

Egypt

Central Contacts

Mohamed Adel Mohamed hassan

Role: CONTACT

mohamedadel44247@gmail.com

+21126633498

Facility Contacts

Mohamed Adel Mohamed Hassan

Role: primary

mohamedadel44247@gmail.com

+21126633498

References

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Reference Type: BACKGROUND

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Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

Reference Type: BACKGROUND

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European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. Diabetologia. 2016 Jun;59(6):1121-40. doi: 10.1007/s00125-016-3902-y. No abstract available.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Liver fibrosis in dm

Identifier Type: -

Identifier Source: org_study_id