- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734599
NMR-based Metabolic Profiling Identifies High Risk of MAFLD Patients With Advanced Fibrosis
NMR-based Metabolic Profiling Identifies High Risk of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Patients With Advanced Fibrosis: An Observational, Multi-center Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bin Cheng, Doctor
- Phone Number: 027-83663334
- Email: bcheng@tjh.tjmu.edu.cn
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
• 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;
- 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.).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
|
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)) |
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
|
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)) |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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follow-up up to 24 months
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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.
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follow-up up to 24 months
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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
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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.
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follow-up up to 24 months
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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
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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.
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follow-up up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance index (HOMA-IR) comparison between control groups and MAFLD participants.
Time Frame: follow-up up to 24 months
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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) |
follow-up up to 24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Bin Cheng Doctor, Tongji Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAFLD-NMR 2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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