Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.

December 19, 2020 updated by: Michael Melad Fekry Endrawes, Assiut University
assessment of NAFLD among diabetic, pre-diabetic and non diabetic participants Using Non Invasive Methods.And correlation between lab and radiological methods .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Non alcoholic fatty liver disease (NAFLD) is a major public health problem. with 10-30% prevalence worldwide , and is a common cause of chronic liver disease and the third most common cause of liver transplantation .

NAFLD can range from simple steatosis in the absence of inflammation to nonalcoholic steatohepatitis, liver cirrhosis, and hepatocellular carcinoma (HCC) .

Major risk factors for NAFLD include obesity, hypertension , hyperlipidemia , hypertriglyceridemia , and type-2-diabetes mellitus (T2DM) .

The gold standard in the diagnosis of NAFLD is liver biopsy; however, it is sometimes associated with some complications that include bleeding, bile leak, infection, and other potential life-threatening issues. The accuracy of the MRI, computed tomography, and ultrasound imaging in diagnosis of NAFLD is low; hence, Fibroscan was introduced .

This is a non-invasive, simple-to-perform imaging modality with high accuracy to assess liver stiffness and hepatic fat deposition. Non-invasive diagnosis is based on clinical and biochemical markers, scoring models, and algorithms of methods which have sufficient sensitivity, specificity, and reproducibility .

Study Type

Observational

Enrollment (Anticipated)

150

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 Contact Backup

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

participants older than 18 years with no definite cause of nafld in our out patient clinic.

Description

Inclusion Criteria:

  • the participants are divided into 3 groups: the diabetic group patients (T2DM) ,the pre-diabetic and the non diabetic one. The diagnosis will be according to the American Diabetes Association (ADA) clinical practice recommendations-2019

Exclusion Criteria:

  • patients under the age of 18.
  • patients with viral hepatitis (HBV - HCV).
  • Subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications).
  • history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis).
  • Body Mass Index (BMI) > 35 (to avoid the possibility of Fibroscan failure).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetic participants
HBA1C : 6.5% or higher Fasting Plasma Glucose : 126 mg/dl or higher Oral Glucose Tolerance Test : 200 mg/dl or higher Random Plasma Glucose Test : greater than or equal to 200 mg/dl
Device: fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
Other Names:
  • Transient Elastography
prediabetic participants
HBA1C : 5.7% to 6.4% Fasting Plasma Glucose : 100 mg/dl to 125 mg/dl Oral Glucose Tolerance Test : 140 mg/dl to 199 mg/dl
Device: fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
Other Names:
  • Transient Elastography
non diabetic participants
HBA1C : less than 5.7% Fasting Plasma Glucose : less than 100 mg/dl Oral Glucose Tolerance Test : less than 140 mg/dl
Device: fibroscan
Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
Other Names:
  • Transient Elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between lab and radiological methods
Time Frame: 2 days
results of fibroscan, lab investigations include Complete blood picture Fasting plasma glucose (FBG) and Glycated hemoglobin (HbA1C) Liver function tests including ( serum bilirubin , serum albumin , ALT , AST , ALP , prothrombin time and INR ) kidney function tests. Lipid profile including (serum cholesterol and triglycerides ). hepatitis marker (HBs Ag , Anti-HCV Ab). and NAFLD Fibrosis Score will be correlated
2 days

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: lobna a ahmed, professor, Assiut University

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)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

September 12, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • non alcoholic fatty liver

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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