Mechanism of Serum PRL in the Development of MAFLD

Study Overview
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Brief Summary
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Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).

Official Title
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Mechanism of Serum PRL in the Development of MAFLD

Conditions
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Type2 Diabetes, Fatty Liver, Nonalcoholic, Liver Fibrosis

Intervention / Treatment
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* Other: non-invasive method, Fibroscan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 65 years old, underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination Exclusion Criteria: other known chronic liver diseases, such as chronic hepatitis B or C, autoimmune hepatitis, and haemochromatosis pre-existing active cancer, renal dysfunction, severe liver dysfunction, congestive heart failure or free abdominal fluid history of hyperthyroidism or hypothyroidism, pituitary diseases, and other types of diabetes significant alcohol consumption pregnancy receiving any therapeutic methods that could lead to liver steatosis or fibrosis, influence the glucolipid metabolism, or PRL levels, such as lipid-lowering, and PRL-lowering agents (bromocriptine) within 6 months prior to this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MAFLD and Non-MAFLD<br> | Other: non-invasive method, Fibroscan<br>* Liver Ultrasound and transient elastography (FibroScan®)<br>|
| Steatosis and Non-Steatosis<br> | Other: non-invasive method, Fibroscan<br>* Liver Ultrasound and transient elastography (FibroScan®)<br>|
| Fibrosis and Non-Fibrosis<br> | Other: non-invasive method, Fibroscan<br>* Liver Ultrasound and transient elastography (FibroScan®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of MAFLD proposed by the international expert consensus statement in 2020 | MAFLD was diagnosed based on evidence of ultrasonically diagnosed hepatic steatosis in addition to one of the three criteria proposed by the international expert consensus statement in 2020, namely overweight/obesity, T2DM, or metabolic dysregulation regardless of alcohol consumption or other concomitant liver diseases. Metabolic dysregulation was defined by the presence of at least two metabolic risk abnormalities found in lean or normal weight patients, including hypertension, dyslipidemia, hyperglycemia, IR, and high CRP levels. | 2019-2024 | 
| PRL | serum prolactin levels | 2019-2024 | 
| High PRL (HP) | HP was defined as serum PRL ≥ 324mIU/L in males or ≥ 496mIU/L in females according to the normal reference value of serum PRL in our hospital. | 2019-2024 | 
| Normal PRL (NP) | NP was defined as serum PRL < 324mIU/L in males or < 496mIU/L in females. | 2019-2024 | 
| Diagnosis of hepatic steatosis | Those who have hepatic steatosis if CAP value ≥ 248 dB/m, which was obtained from transient elastography (FibroScan®) using the M probe or the XL probe. | 2019-2024 | 
| Diagnosis of significant hepatic fibrosis | those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes) | 2019-2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model assessment of IR (HOMA-IR) | HOMA-IR was calculated as described by Matthews et al: FPG (mmol/L) × FINS (mU/L) /22.5. | 2019-2024 | 
| Hypertension | it was defined by blood pressure ≥130/85mmHg or antihypertensive drugs. | 2019-2024 | 
| Dyslipidemia | it was defined by plasma TG ≥ 1.7mmol/L in the total population or plasma HDL-C < 1.0 mmol/L for men and < 1.3 mmol/L for women, or specific drug treatment. | 2019-2024 | 
| Overweight or obesity | it was defined as BMI ≥ 23 kg/m2 in Asians. | 2019-2024 | 
| Abdominal obesity | It was diagnosed when WC ≥ 90/80 cm in Asian men and women. | 2019-2024 | 
| T2DM | it was diagnosed according to the guideline for the prevention and treatment of T2DM in China (2020 edition) | 2019-2024 | 
| High CRP | plasma CRP > 2 mg/L | 2019-2024 | 
| High HOMA-IR | HOMA-IR≥ 2.5 | 2019-2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Metabolic associated fatty liver disease,, Prolactin