Non-alcoholic Fatty Liver DiseaseNCT06908122
Validity of Laboratory Biomarkers in Diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD) and It's Consequences
An observational study of Non-alcoholic Fatty Liver Disease, run by Assiut University.
Trial summary
The validity of laboratory biomarkers in the diagnosis of NAFLD is still not established, and adherence to a healthy dietary lifestyle for those patients in our community is not well studied. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- laboratory biomarkers in the diagnosis of NAFLD disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed as having NAFLD attend outpatient clinics characterized by an age over 18 years.
Who may be able to join
- All adult patients attending outpatient clinics characterized by an age over 18 years.
- Patients diagnosed as NAFLD.
Who cannot join
- Patients younger than 18 years old.
- Patients diagnosed with viral hepatitis to avoid other causes of liver fibrosis. .
- Patients with alcoholic fatty liver (more than three standard drinks per day for men or more than two standard drinks per day for women).
- Patients receiving treatment with drugs known to promote liver steatosis (for example, tamoxifen, amiodarone, estrogen, or corticosteroids).
- Patients with malignant tumors or other severe organ dysfunction diseases.
About this study
The validity of laboratory biomarkers in the diagnosis of NAFLD is still not established, and adherence to a healthy dietary lifestyle for those patients in our community is not well studied.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is characterized by excessive hepatic fat accumulation, associated with insulin resistance, and defined as the histological presence of steatosis in >5% hepatocytes.
NAFLD is an umbrella terminology incorporating a spectrum of liver diseases ranging from simple steatosis (nonalcoholic fatty liver), steatohepatitis (nonalcoholic steatohepatitis, NASH), and cirrhosis. NAFLD is also the leading cause of liver cirrhosis, hepatocellular carcinoma, and death.
Early diagnosis and assessment of NAFLD and liver fibrosis are essential for monitoring disease progression and selecting the best treatment options for affected individuals.
Given that liver biopsy had considerable disadvantages, there was a dire need for genuine noninvasive methods for NAFLD detection and risk assessment. The serum markers and other indicators is valuable for screening diseases due to their convenience, low cost, and accuracy of diagnosis Unhealthy dietary composition is an important factor in the progression of non- alcoholic fatty liver disease. Many studies surround the benefits of a Mediterranean diet in conditions such as metabolic syndrome, T2DM, and cardiovascular disease; such conditions often coexist and have a pathophysiological link with NAFLD.
The Mediterranean diet (MeD) is defined as a plant-based diet characterized by a high intake of fruits and vegetables, legumes, whole grains, and a high ratio of monounsaturated fatty acids (MUFA), which is associated with a lower risk of many chronic diseases
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- laboratory biomarkers in the diagnosis of NAFLD disease
- 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.
laboratory biomarkers in the diagnosis of NAFLD diseaseDiagnostic test
All included patients will be assessed as follows:
- Questionnaire: different questionnaire variables extrapolated from study published by Xin Li, 2024, Bao et al., 2024 (8), (9).The questionnaire will be divided into six parts: First section includes demographic characteristics of patients as (name , age, gender, occupation, educational level and special habits) The second section includes chronic diseases-related questions and drug administration as if a patient were diagnosed with chronic disease, on treatment and drugs used.
The third section for assessment of dietary lifestyle includes:
nutrition adherence to Mediterranean will be assessed by a validated 17-item MedDiet adherence questionnaire, which all participants will answer. A score will be given for each met objective: 1 (compliance) or 0 (non-compliance).
The counseling session will be about the Mediterranean diet program, and a brochure will be given to each patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of lab biomarkers in the diagnosis of nonalcoholic fatty liver disease (NAFLD) and it's consequences in comparison with abdominal ultrasound and fibroscan.
different laboratory ratio will be calculated to assess validity of different laboratory markers in diagnosis of NAFLD
Measured: 1 year
Secondary outcomes (1)
dietary life style and conduct of Mediterranean diet programme counseling for NAFLD patients attending Assiut university hospitals
-nutrition adherence to Mediterranean will be assessed by a validated 17-item MedDiet adherence questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahy nour Zoghby Abd elhi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908122
- Sponsor's protocol ID
- FAM.AssiutU
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko E, Yoon EL, Jun DW. Risk factors in nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S79-S85. doi: 10.3350/cmh.2022.0398. Epub 2022 Dec 14.
PubMed 36517003Han SK, Baik SK, Kim MY. Non-alcoholic fatty liver disease: Definition and subtypes. Clin Mol Hepatol. 2023 Feb;29(suppl):S5-S16. doi: 10.3350/cmh.2022.0424. Epub 2022 Dec 28.
PubMed 36577427Montemayor S, Mascaro CM, Ugarriza L, Casares M, Llompart I, Abete I, Zulet MA, Martinez JA, Tur JA, Bouzas C. Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study. Nutrients. 2022 Aug 3;14(15):3186. doi: 10.3390/nu14153186.
PubMed 35956364George ES, Reddy A, Nicoll AJ, Ryan MC, Itsiopoulos C, Abbott G, Johnson NA, Sood S, Roberts SK, Tierney AC. Impact of a Mediterranean diet on hepatic and metabolic outcomes in non-alcoholic fatty liver disease: The MEDINA randomised controlled trial. Liver Int. 2022 Jun;42(6):1308-1322. doi: 10.1111/liv.15264. Epub 2022 Apr 26.
PubMed 35357066Doustmohammadian A, Clark CCT, Maadi M, Motamed N, Sobhrakhshankhah E, Ajdarkosh H, Mansourian MR, Esfandyari S, Hanjani NA, Nikkhoo M, Zamani F. Favorable association between Mediterranean diet (MeD) and DASH with NAFLD among Iranian adults of the Amol Cohort Study (AmolCS). Sci Rep. 2022 Feb 8;12(1):2131. doi: 10.1038/s41598-022-06035-8.
PubMed 35136128
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Laboratory Biomarkers in Diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD) and It's Consequences
- ClinicalTrials.gov ID
- NCT06908122
- Acronym / sponsor ID
- FAM.AssiutU
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Apr 2025 (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.
The validity of laboratory biomarkers in the diagnosis of NAFLD is still not established, and adherence to a healthy dietary lifestyle for those patients in our community is not well studied.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is characterized by excessive hepatic fat accumulation, associated with insulin resistance, and defined as the histological presence of steatosis in >5% hepatocytes.
NAFLD is an umbrella terminology incorporating a spectrum of liver diseases ranging from simple steatosis (nonalcoholic fatty liver), steatohepatitis (nonalcoholic steatohepatitis, NASH), and cirrhosis. NAFLD is also the leading cause of liver cirrhosis, hepatocellular carcinoma, and death.
Early diagnosis and assessment of NAFLD and liver fibrosis are essential for monitoring disease progression and selecting the best treatment options for affected individuals.
Given that liver biopsy had considerable disadvantages, there was a dire need for genuine noninvasive methods for NAFLD detection and risk assessment. The serum markers and other indicators is valuable for screening diseases due to their convenience, low cost, and accuracy of diagnosis Unhealthy dietary composition is an important factor in the progression of non- alcoholic fatty liver disease. Many studies surround the benefits of a Mediterranean diet in conditions such as metabolic syndrome, T2DM, and cardiovascular disease; such conditions often coexist and have a pathophysiological link with NAFLD.
The Mediterranean diet (MeD) is defined as a plant-based diet characterized by a high intake of fruits and vegetables, legumes, whole grains, and a high ratio of monounsaturated fatty acids (MUFA), which is associated with a lower risk of many chronic diseases
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed as having NAFLD attend outpatient clinics characterized by an age over 18 years.
Key inclusion criteria (2 listed)
- All adult patients attending outpatient clinics characterized by an age over 18 years.
- Patients diagnosed as NAFLD.
Key exclusion criteria (5 listed)
- Patients younger than 18 years old.
- Patients diagnosed with viral hepatitis to avoid other causes of liver fibrosis. .
- Patients with alcoholic fatty liver (more than three standard drinks per day for men or more than two standard drinks per day for women).
- Patients receiving treatment with drugs known to promote liver steatosis (for example, tamoxifen, amiodarone, estrogen, or corticosteroids).
- Patients with malignant tumors or other severe organ dysfunction diseases.
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 |
|---|---|---|
| laboratory biomarkers in the diagnosis of NAFLD diseaseAll included patients will be assessed as follows: 1. Questionnaire: different questionnaire variables extrapolated from study published by Xin Li, 2024, Bao et al., 2024 (8), (9).The questionnaire will be divided into six parts: First section includes demographic characteristics of patients as (name , age, gender, occupation, educational level and special habits) The second section includes chronic diseases-related questions and drug administration as if a patient were diagnosed with chronic disease, on treatment and drugs used. The third section for assessment of dietary lifestyle includes: nutrition adherence to Mediterranean will be assessed by a validated 17-item MedDiet adherence questionnaire, which all participants will answer. A score will be given for each met objective: 1 (compliance) or 0 (non-compliance). The counseling session will be about the Mediterranean diet program, and a brochure will be given to each patient. | Diagnostic test | – |
Primary outcome
Validity of lab biomarkers in the diagnosis of nonalcoholic fatty liver disease (NAFLD) and it's consequences in comparison with abdominal ultrasound and fibroscan.
Time frame: 1 year
different laboratory ratio will be calculated to assess validity of different laboratory markers in diagnosis of NAFLD
1 secondary outcome
dietary life style and conduct of Mediterranean diet programme counseling for NAFLD patients attending Assiut university hospitals
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 36517003Ko E, Yoon EL, Jun DW. Risk factors in nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S79-S85. doi: 10.3350/cmh.2022.0398. Epub 2022 Dec 14.
- Background: PubMed 36577427Han SK, Baik SK, Kim MY. Non-alcoholic fatty liver disease: Definition and subtypes. Clin Mol Hepatol. 2023 Feb;29(suppl):S5-S16. doi: 10.3350/cmh.2022.0424. Epub 2022 Dec 28.
- Background: PubMed 35956364Montemayor S, Mascaro CM, Ugarriza L, Casares M, Llompart I, Abete I, Zulet MA, Martinez JA, Tur JA, Bouzas C. Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study. Nutrients. 2022 Aug 3;14(15):3186. doi: 10.3390/nu14153186.
- Background: PubMed 35357066George ES, Reddy A, Nicoll AJ, Ryan MC, Itsiopoulos C, Abbott G, Johnson NA, Sood S, Roberts SK, Tierney AC. Impact of a Mediterranean diet on hepatic and metabolic outcomes in non-alcoholic fatty liver disease: The MEDINA randomised controlled trial. Liver Int. 2022 Jun;42(6):1308-1322. doi: 10.1111/liv.15264. Epub 2022 Apr 26.
- Background: PubMed 35136128Doustmohammadian A, Clark CCT, Maadi M, Motamed N, Sobhrakhshankhah E, Ajdarkosh H, Mansourian MR, Esfandyari S, Hanjani NA, Nikkhoo M, Zamani F. Favorable association between Mediterranean diet (MeD) and DASH with NAFLD among Iranian adults of the Amol Cohort Study (AmolCS). Sci Rep. 2022 Feb 8;12(1):2131. doi: 10.1038/s41598-022-06035-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, 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 2 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of lab biomarkers in the diagnosis of nonalcoholic fatty liver disease (NAFLD) and it's consequences in comparison with abdominal ultrasound and fibroscan. (time frame: 1 year). 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 NCT06908122, which also lists 5 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 3 Apr 2025.