Non Alcoholic Fatty LiverNCT04553796
Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
An observational study of Non Alcoholic Fatty Liver, run by Assiut University.
Trial summary
assessment of NAFLD among diabetic, pre-diabetic and non diabetic participants Using Non Invasive Methods.And correlation between lab and radiological methods . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver
- What is being tested?
- fibroscan
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants older than 18 years with no definite cause of nafld in our out patient clinic.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
assessment of NAFLD among diabetic, pre-diabetic and non diabetic participants Using Non Invasive Methods.And correlation between lab and radiological methods .
Read the 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 .
- Conditions
- Non Alcoholic Fatty Liver
- Being tested
- fibroscan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibroscanDevice
Also called Transient Elastography
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: fibroscan | |
| 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 Receives: Device: fibroscan | |
| 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 Receives: Device: fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between lab and radiological methods
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Melad Fekry Endrawes, Assiut University
- Investigators
- lobna a ahmed, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553796
- Sponsor's protocol ID
- non alcoholic fatty liver
- Status last verified
- Dec 2020
- First submitted
- 12 Sep 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
PubMed 27062661Lv S, Jiang S, Liu S, Dong Q, Xin Y, Xuan S. Noninvasive Quantitative Detection Methods of Liver Fat Content in Nonalcoholic Fatty Liver Disease. J Clin Transl Hepatol. 2018 Jun 28;6(2):217-221. doi: 10.14218/JCTH.2018.00021. Epub 2018 Jun 22.
PubMed 29951367Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17.
PubMed 25887357Dharmalingam M, Yamasandhi PG. Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus. Indian J Endocrinol Metab. 2018 May-Jun;22(3):421-428. doi: 10.4103/ijem.IJEM_585_17.
PubMed 30090738Esterson YB, Grimaldi GM. Radiologic Imaging in Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Clin Liver Dis. 2018 Feb;22(1):93-108. doi: 10.1016/j.cld.2017.08.005. Epub 2017 Oct 10.
PubMed 29128063de Ledinghen V, Vergniol J, Foucher J, Merrouche W, le Bail B. Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography. Liver Int. 2012 Jul;32(6):911-8. doi: 10.1111/j.1478-3231.2012.02820.x.
PubMed 22672642Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.
PubMed 30660725Sheth H, Bagasrawala S, Shah M, Ansari R, Olithselvan A, Lakdawala M. The HAALT Non-invasive Scoring System for NAFLD in Obesity. Obes Surg. 2019 Aug;29(8):2562-2570. doi: 10.1007/s11695-019-03880-x.
PubMed 31016455Wang CC, Jhu JJ. On the Application of Clustering and Classification Techniques to Analyze Metabolic Syndrome Severity Distribution Area and Critical Factors. Int J Environ Res Public Health. 2019 May 6;16(9):1575. doi: 10.3390/ijerph16091575.
PubMed 31064061American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
PubMed 30559228Angulo P, Hui JM, Marchesini G, Bugianesi E, George J, Farrell GC, Enders F, Saksena S, Burt AD, Bida JP, Lindor K, Sanderson SO, Lenzi M, Adams LA, Kench J, Therneau TM, Day CP. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007 Apr;45(4):846-54. doi: 10.1002/hep.21496.
PubMed 17393509
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nonalcoholic Fatty Liver Disease in Diabetic and Prediabetic Patients Using Noninvasive Methods.
- ClinicalTrials.gov ID
- NCT04553796
- Acronym / sponsor ID
- non alcoholic fatty liver
- Conditions
- Non Alcoholic Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assessment of NAFLD among diabetic, pre-diabetic and non diabetic participants Using Non Invasive Methods.And correlation between lab and radiological methods .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diabetic participants | – | Device: fibroscanHBA1C : 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 |
| prediabetic participants | – | Device: fibroscanHBA1C : 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 |
| non diabetic participants | – | Device: fibroscanHBA1C : less than 5.7% Fasting Plasma Glucose : less than 100 mg/dl Oral Glucose Tolerance Test : less than 140 mg/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants older than 18 years with no definite cause of nafld in our out patient clinic.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibroscanAlso: Transient ElastographyFibroscan 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 | Device | diabetic participants, non diabetic participants, prediabetic participants |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 27062661European 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. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
- Background: PubMed 29951367Lv S, Jiang S, Liu S, Dong Q, Xin Y, Xuan S. Noninvasive Quantitative Detection Methods of Liver Fat Content in Nonalcoholic Fatty Liver Disease. J Clin Transl Hepatol. 2018 Jun 28;6(2):217-221. doi: 10.14218/JCTH.2018.00021. Epub 2018 Jun 22.
- Background: PubMed 25887357Bazick J, Donithan M, Neuschwander-Tetri BA, Kleiner D, Brunt EM, Wilson L, Doo E, Lavine J, Tonascia J, Loomba R. Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD. Diabetes Care. 2015 Jul;38(7):1347-55. doi: 10.2337/dc14-1239. Epub 2015 Apr 17.
- Background: PubMed 30090738Dharmalingam M, Yamasandhi PG. Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus. Indian J Endocrinol Metab. 2018 May-Jun;22(3):421-428. doi: 10.4103/ijem.IJEM_585_17.
- Background: PubMed 29128063Esterson YB, Grimaldi GM. Radiologic Imaging in Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Clin Liver Dis. 2018 Feb;22(1):93-108. doi: 10.1016/j.cld.2017.08.005. Epub 2017 Oct 10.
- Background: PubMed 22672642de Ledinghen V, Vergniol J, Foucher J, Merrouche W, le Bail B. Non-invasive diagnosis of liver steatosis using controlled attenuation parameter (CAP) and transient elastography. Liver Int. 2012 Jul;32(6):911-8. doi: 10.1111/j.1478-3231.2012.02820.x.
- Background: PubMed 30660725Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18.
- Background: PubMed 31016455Sheth H, Bagasrawala S, Shah M, Ansari R, Olithselvan A, Lakdawala M. The HAALT Non-invasive Scoring System for NAFLD in Obesity. Obes Surg. 2019 Aug;29(8):2562-2570. doi: 10.1007/s11695-019-03880-x.
- Background: PubMed 31064061Wang CC, Jhu JJ. On the Application of Clustering and Classification Techniques to Analyze Metabolic Syndrome Severity Distribution Area and Critical Factors. Int J Environ Res Public Health. 2019 May 6;16(9):1575. doi: 10.3390/ijerph16091575.
- Background: PubMed 30559228American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
- Background: PubMed 17393509Angulo P, Hui JM, Marchesini G, Bugianesi E, George J, Farrell GC, Enders F, Saksena S, Burt AD, Bida JP, Lindor K, Sanderson SO, Lenzi M, Adams LA, Kench J, Therneau TM, Day CP. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007 Apr;45(4):846-54. doi: 10.1002/hep.21496.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lobna a ahmed, professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Non Alcoholic Fatty Liver, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael m Fekry, doctor (+201207601294, mesho0js@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between lab and radiological methods (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553796, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.