Mechanism of Serum PRL in the Development of MAFLD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- PRL
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
PRL
Time Frame: 2019-2024
serum prolactin levels
Normal PRL (NP)
Time Frame: 2019-2024
NP was defined as serum PRL \< 324mIU/L in males or \< 496mIU/L in females.
Diagnosis of significant hepatic fibrosis
Time Frame: 2019-2024
those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes)
Diagnosis of MAFLD proposed by the international expert consensus statement in 2020
Time Frame: 2019-2024
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.
Diagnosis of hepatic steatosis
Time Frame: 2019-2024
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.
High PRL (HP)
Time Frame: 2019-2024
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.
Secondary Outcomes
- Hypertension(2019-2024)
- T2DM(2019-2024)
- High HOMA-IR(2019-2024)
- Homeostasis model assessment of IR (HOMA-IR)(2019-2024)
- Overweight or obesity(2019-2024)
- Abdominal obesity(2019-2024)
- High CRP(2019-2024)
- Dyslipidemia(2019-2024)
Investigators
Shen Qu
Principle investigator
Shanghai 10th People's Hospital