Metabolic Disease Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 1194 |
Est. completion date | May 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.). |
Country | Name | City | State |
---|---|---|---|
China | Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Huazhong University of Science and Technology |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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) |
follow-up up to 24 months |
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