Metabolic Dysfunction-associated Fatty Liver DiseaseNCT05734599
NMR-based Metabolic Profiling Identifies High Risk of MAFLD Patients With Advanced Fibrosis
An observational study of Metabolic Dysfunction-associated Fatty Liver Disease and Metabolic Disease, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study aim to find out metabolic molecules in blood and urine which could identify high risk of advanced fibrosis in MAFLD patients via NMR-based metabolic profiling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease, Metabolic Disease
- What is being tested?
- NMR-based metabolic profiling
- Type of treatment
- Medical device
- How many people
- 1,194 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 May 2024
- 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: The cohort selected patients with and without MAFLD who underwent VCTE and serological tests.
Who may be able to join
- Patients with MAFLD
- Meet the diagnostic criteria in the 2020 Asian Pacific Association for the Study of the Liver (APASL) Clinical Practice Guidelines for the Diagnosis and Management of Metabolism-Related Fatty Liver Disease
- Liver Vibration-controlled Transient Elastography (FibroTouch) with evidence of hepatic steatosis (CAP value≥ 240db/m)
- Age≥ 18 years
- Healthy controls:
- Liver Vibration-controlled Transient Elastography (FibroTouch) showed no fatty liver and no liver fibrosis;
- No history of other chronic diseases, no use of appropriate prescription drugs;
- The amount of alcohol consumed was ≤8 g per day for women and ≤16g per day for men.
Who cannot join
- • Chronic viral hepatitis, alcoholic liver disease or excessive alcohol consumption (more than 30 g of alcohol per day for men and 20 g for women), decompensated cirrhosis;
- Chronic liver disease due to other causes (e.g., autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson disease, alpha-1 antitrypsin deficiency, celiac disease)
- Imaging findings suggest a malignant mass of the liver;
- Patients with other malignant tumors (excluding cured ones);
- Have secondary obesity due to endocrine, genetic, metabolic, and central nervous system diseases. Judge by professional doctors whether it is hypothalamic obesity, pituitary obesity, hypothyroid obesity, obesity caused by Cushing's syndrome and hypogonadal obesity;
- Have received or are currently receiving medical or surgical treatment for weight loss in the past three months or are currently being treated;
Show all 11Show fewer
- Weight fluctuations of ≥ 5 kg over the past two months;
- Currently pregnant or nursing;
- Severe cardiovascular and cerebrovascular disease or stage III hypertension;
- Hepatitis B, active tuberculosis, AIDS and other infectious diseases;
- Those who are unable to sign the informed consent form (such as mental illness and drug addiction, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: NMR-based Metabolic Profiling Identifies High Risk of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Patients With Advanced Fibrosis: An Observational, Multi-center Study
This study aim to find out metabolic molecules in blood and urine which could identify high risk of advanced fibrosis in MAFLD patients via NMR-based metabolic profiling.
Read the detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) is currently the most common liver disease in the world, with an incidence of 29.81% in China. Studies have shown that the severity of liver fibrosis is the most important predictor of disease progression in patients with MAFLD, and the more severe the degree of liver fibrosis, the worse the prognosis. Therefore, discovering non-invasive indicators that can predict the risk and identify people at high risk of MAFLD with advanced liver fibrosis is essential for early clinical intervention in order to improve their clinical prognosis. Some non-invasive tests like Vibration-controlled Transient Elastography (VCTE), Fibrosis-4 Index (FIB-4), and NAFLD fibrosis score (NFS) have been used to evaluate the liver fibrosis state in MAFLD patients, but lack of prospect in metabolic molecular level. Nuclear magnetic resonance(NMR)-based metabolomic profiling can identify and quantify significant biological molecules in tissue extracts, body fluids (blood, urine, cerebrospinal fluid, saliva, etc.), and secretions, and has wide applications in the study of cancer and other metabolic diseases. Therefore, this study intends to collect the demographic characteristics and serological indicators of MAFLD patients detected by liver VCTE, and use NMR profiling to perform metabolomic analysis on their peripheral blood and urine samples, in order to discover potential non-invasive biomarkers that can be used to predict and evaluate MAFLD advanced liver fibrosis, and further verify these MAFLD metabolomic indicators that may be associated with advanced liver fibrosis through multi-center clinical studies, in an attempt to provide ideal non-invasive biomarkers for MAFLD progression prediction and clinical intervention monitoring.
- Being tested
- NMR-based metabolic profiling
- Keywords
- NMR-profiling, advanced fibrosis
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMR-based metabolic profilingDevice
Clinical parameters and VCTE results of each patient will be collected. Patients will be grouped into two groups according to VCTE, FIB-4 and NFS, and undergo NMR-based metabolic profiling
| Study group | Role | What they receive |
|---|---|---|
| MAFLD-control group | Participants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are not MAFLD patients and are willing to participate in this study. Receives: Device: NMR-based metabolic profiling | |
| MAFLD-high hardness group | Participants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are defined to have MAFLD and are willing to participate in this study.
The risk of advanced liver fibrosis was estimated based on the LSM value, FIB-4 score, and NAFLD fibrosis score (NFS), and patients were then divided into groups of low and high hardness according to the risk measured, as shown below:
High hardness group:
participants meet one of the following three requirements: LSM≥ 11.4 kPa；9.9<LSM≤11.4 kPa and NFS≥0.676;9.9<LSM≤11.4 kPa and FIB-4≥2.67.
NFS = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × Fasting blood glucose abnormalities / diabetes mellitus (with=1, none=0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×109/L) - 0.66 × albumin (g/dl) FIB-4 = （age(years) x AST [U/L]) / ((PLT [109/L]) x (ALT [U/L])^(1/2)) Receives: Device: NMR-based metabolic profiling | |
| MAFLD-low hardness group | Participants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are defined to have MAFLD and are willing to participate in this study.
The risk of advanced liver fibrosis was estimated based on the LSM value, FIB-4 score, and NAFLD fibrosis score (NFS), and patients were then divided into groups of low and high hardness according to the risk measured, as shown below:
Low hardness group:
participants who do not meet the requirements of the high hardness group are low hardness group: LSM < 9.9 kPa；9.9<LSM≤11.4 kPa with NFS < 0.676 and FIB-4<2.67.
NFS = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × Fasting blood glucose abnormalities / diabetes mellitus (with=1, none=0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×109/L) - 0.66 × albumin (g/dl) FIB-4 = （age(years) x AST [U/L]) / ((PLT [109/L]) x (ALT [U/L])^(1/2)) Receives: Device: NMR-based metabolic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMR profiling to discover the difference of lipids and lipoproteins in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
NMR-based metabolic profiling was used to detect and compare the lipids and lipoproteins of peripheral blood samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
Measured: follow-up up to 24 months
NMR profiling to discover the difference of lipoproteins in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
NMR-based metabolic profiling was used to detect and compare the lipoproteins of peripheral blood samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
Measured: follow-up up to 24 months
NMR profiling to discover the difference of amino acid and their derivatives in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
NMR-based metabolic profiling was used to detect and compare the amino acid and its derivatives of peripheral blood and urine samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
Measured: follow-up up to 24 months
NMR profiling to discover the difference of Carbohydrates and their derivatives in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
NMR-based metabolic profiling was used to detect and compare the Carbohydrates and their derivatives of peripheral blood and urine samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
Measured: follow-up up to 24 months
Secondary outcomes (1)
Insulin resistance index (HOMA-IR) comparison between control groups and MAFLD participants.
The insulin resistance index in different groups, as mentioned above, were calculated and analyzed, in order to explore the factors associated with insulin resistance and diabetes in MAFLD.
HOMA-IR=（FPG×FINS）/22.5, FPG (mmol/L), FINS(mIU/L)
Measured: follow-up up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
- Investigators
- Bin Cheng Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734599
- Sponsor's protocol ID
- MAFLD-NMR 2022
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMR-based Metabolic Profiling Identifies High Risk of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Patients With Advanced Fibrosis: An Observational, Multi-center Study
- ClinicalTrials.gov ID
- NCT05734599
- Acronym / sponsor ID
- MAFLD-NMR 2022
- Keywords
- NMR-profiling, advanced fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,194 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Feb 2023 (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.
This study aim to find out metabolic molecules in blood and urine which could identify high risk of advanced fibrosis in MAFLD patients via NMR-based metabolic profiling.
Detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) is currently the most common liver disease in the world, with an incidence of 29.81% in China. Studies have shown that the severity of liver fibrosis is the most important predictor of disease progression in patients with MAFLD, and the more severe the degree of liver fibrosis, the worse the prognosis. Therefore, discovering non-invasive indicators that can predict the risk and identify people at high risk of MAFLD with advanced liver fibrosis is essential for early clinical intervention in order to improve their clinical prognosis. Some non-invasive tests like Vibration-controlled Transient Elastography (VCTE), Fibrosis-4 Index (FIB-4), and NAFLD fibrosis score (NFS) have been used to evaluate the liver fibrosis state in MAFLD patients, but lack of prospect in metabolic molecular level. Nuclear magnetic resonance(NMR)-based metabolomic profiling can identify and quantify significant biological molecules in tissue extracts, body fluids (blood, urine, cerebrospinal fluid, saliva, etc.), and secretions, and has wide applications in the study of cancer and other metabolic diseases. Therefore, this study intends to collect the demographic characteristics and serological indicators of MAFLD patients detected by liver VCTE, and use NMR profiling to perform metabolomic analysis on their peripheral blood and urine samples, in order to discover potential non-invasive biomarkers that can be used to predict and evaluate MAFLD advanced liver fibrosis, and further verify these MAFLD metabolomic indicators that may be associated with advanced liver fibrosis through multi-center clinical studies, in an attempt to provide ideal non-invasive biomarkers for MAFLD progression prediction and clinical intervention monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAFLD-control group | – | Device: NMR-based metabolic profilingParticipants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are not MAFLD patients and are willing to participate in this study. |
| MAFLD-high hardness group | – | Device: NMR-based metabolic profilingParticipants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are defined to have MAFLD and are willing to participate in this study. The risk of advanced liver fibrosis was estimated based on the LSM value, FIB-4 score, and NAFLD fibrosis score (NFS), and patients were then divided into groups of low and high hardness according to the risk measured, as shown below: High hardness group: participants meet one of the following three requirements: LSM≥ 11.4 kPa；9.9<LSM≤11.4 kPa and NFS≥0.676;9.9<LSM≤11.4 kPa and FIB-4≥2.67. NFS = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × Fasting blood glucose abnormalities / diabetes mellitus (with=1, none=0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×109/L) - 0.66 × albumin (g/dl) FIB-4 = （age(years) x AST [U/L]) / ((PLT [109/L]) x (ALT [U/L])^(1/2)) |
| MAFLD-low hardness group | – | Device: NMR-based metabolic profilingParticipants accepted health examinations including vibration-controlled transient elastography in Tongji and Union hospitals who are defined to have MAFLD and are willing to participate in this study. The risk of advanced liver fibrosis was estimated based on the LSM value, FIB-4 score, and NAFLD fibrosis score (NFS), and patients were then divided into groups of low and high hardness according to the risk measured, as shown below: Low hardness group: participants who do not meet the requirements of the high hardness group are low hardness group: LSM < 9.9 kPa；9.9<LSM≤11.4 kPa with NFS < 0.676 and FIB-4<2.67. NFS = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × Fasting blood glucose abnormalities / diabetes mellitus (with=1, none=0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×109/L) - 0.66 × albumin (g/dl) FIB-4 = （age(years) x AST [U/L]) / ((PLT [109/L]) x (ALT [U/L])^(1/2)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort selected patients with and without MAFLD who underwent VCTE and serological tests.
Key inclusion criteria (8 listed)
- Patients with MAFLD
- Liver Vibration-controlled Transient Elastography (FibroTouch) showed no fatty liver and no liver fibrosis;
- No history of other chronic diseases, no use of appropriate prescription drugs;
- The amount of alcohol consumed was ≤8 g per day for women and ≤16g per day for men.
Key exclusion criteria (11 listed)
- • Chronic viral hepatitis, alcoholic liver disease or excessive alcohol consumption (more than 30 g of alcohol per day for men and 20 g for women), decompensated cirrhosis;
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 |
|---|---|---|
| NMR-based metabolic profilingClinical parameters and VCTE results of each patient will be collected. Patients will be grouped into two groups according to VCTE, FIB-4 and NFS, and undergo NMR-based metabolic profiling | Device | MAFLD-control group, MAFLD-high hardness group, MAFLD-low hardness group |
Primary outcome
NMR profiling to discover the difference of lipids and lipoproteins in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
Time frame: follow-up up to 24 months
NMR-based metabolic profiling was used to detect and compare the lipids and lipoproteins of peripheral blood samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
NMR profiling to discover the difference of lipoproteins in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
Time frame: follow-up up to 24 months
NMR-based metabolic profiling was used to detect and compare the lipoproteins of peripheral blood samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
NMR profiling to discover the difference of amino acid and their derivatives in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
Time frame: follow-up up to 24 months
NMR-based metabolic profiling was used to detect and compare the amino acid and its derivatives of peripheral blood and urine samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
NMR profiling to discover the difference of Carbohydrates and their derivatives in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression
Time frame: follow-up up to 24 months
NMR-based metabolic profiling was used to detect and compare the Carbohydrates and their derivatives of peripheral blood and urine samples of control groups and MAFLD participants including the high and low hardness groups as mentioned above.
1 secondary outcome
Insulin resistance index (HOMA-IR) comparison between control groups and MAFLD participants.
Time frame: follow-up up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
Related trials for Metabolic Dysfunction-associated Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
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.
Bin Cheng Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-associated Fatty Liver Disease and Metabolic Disease, run by Huazhong University of Science and Technology at 1 site in China.
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 8 inclusion and 11 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bin Cheng, Doctor (027-83663334, bcheng@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMR profiling to discover the difference of lipids and lipoproteins in peripheral blood and urine that can be used to predict liver fibrosis in MAFLD progression (time frame: follow-up up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.