NMR-based Metabolic Profiling Identifies High Risk of MAFLD Patients With Advanced Fibrosis

NCT05734599 | Unknown

• 1 other identifier: MAFLD-NMR 2022
• Study Type: observational
• Target: 1,194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Dysfunction-associated Fatty Liver Disease; Metabolic Disease

Keywords

NMR-profiling; advanced fibrosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  follow-up up to 24 months

Secondary Outcomes (1)

• Insulin resistance index (HOMA-IR) comparison between control groups and MAFLD participants.

  follow-up up to 24 months

Study Arms (3)

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.

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))

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))

Device: NMR-based metabolic profiling

Interventions

NMR-based metabolic profiling DEVICE

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-control group; MAFLD-high hardness group; MAFLD-low hardness group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort selected patients with and without MAFLD who underwent VCTE and serological tests.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood and urine samples are collected from participants.

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Bin Cheng Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cheng, Doctor

CONTACT

027-83663334; bcheng@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)