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Mechanism of Serum PRL in the Development of MAFLD

Mechanism of Serum PRL in the Development of MAFLD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05525884
Enrollment
1000
Registered
2022-09-02
Start date
2017-01-01
Completion date
2024-01-31
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Nonalcoholic, Liver Fibrosis, Type2 Diabetes

Keywords

Type 2 Diabetes, Metabolic associated fatty liver disease,, Prolactin

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).

Interventions

OTHERnon-invasive method, Fibroscan

Liver Ultrasound and transient elastography (FibroScan®)

Sponsors

Shen Qu
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of MAFLD proposed by the international expert consensus statement in 20202019-2024MAFLD 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.
PRL2019-2024serum prolactin levels
High PRL (HP)2019-2024HP 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.
Normal PRL (NP)2019-2024NP was defined as serum PRL \< 324mIU/L in males or \< 496mIU/L in females.
Diagnosis of hepatic steatosis2019-2024Those 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.
Diagnosis of significant hepatic fibrosis2019-2024those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes)

Secondary

MeasureTime frameDescription
High CRP2019-2024plasma CRP \> 2 mg/L
Homeostasis model assessment of IR (HOMA-IR)2019-2024HOMA-IR was calculated as described by Matthews et al: FPG (mmol/L) × FINS (mU/L) /22.5.
High HOMA-IR2019-2024HOMA-IR≥ 2.5
Hypertension2019-2024it was defined by blood pressure ≥130/85mmHg or antihypertensive drugs.
Dyslipidemia2019-2024it 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.
Overweight or obesity2019-2024it was defined as BMI ≥ 23 kg/m2 in Asians.
Abdominal obesity2019-2024It was diagnosed when WC ≥ 90/80 cm in Asian men and women.
T2DM2019-2024it was diagnosed according to the guideline for the prevention and treatment of T2DM in China (2020 edition)

Countries

China

Contacts

Primary ContactShen Qu
qushencn@hotmail.com+862166301064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026