Mechanism of Serum PRL in the Development of MAFLD

Shen Qu1,000 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Type2 Diabetes Fatty Liver, Nonalcoholic Liver Fibrosis

Interventions

non-invasive method, FibroscanOTHER

Liver Ultrasound and transient elastography (FibroScan®)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2019-2024

PRL

serum prolactin levels

Time frame: 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.

Time frame: 2019-2024

Normal PRL (NP)

NP was defined as serum PRL \< 324mIU/L in males or \< 496mIU/L in females.

Time frame: 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.

Time frame: 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)

Time frame: 2019-2024

Secondary Outcomes

Homeostasis model assessment of IR (HOMA-IR)

Central Contacts

Shen Qu

CONTACT

+862166301064 qushencn@hotmail.com

Data from ClinicalTrials.gov

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