Mechanism of Serum PRL in the Development of MAFLD

Recruiting

• Conditions: Liver Fibrosis; Fatty Liver, Nonalcoholic; Type2 Diabetes
• Interventions: Other: non-invasive method, Fibroscan

• Registration Number: NCT05525884
• Lead Sponsor: Shen Qu

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2021-12-15
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrosis and Non-Fibrosis	non-invasive method, Fibroscan	-
MAFLD and Non-MAFLD	non-invasive method, Fibroscan	-
Steatosis and Non-Steatosis	non-invasive method, Fibroscan	-

Primary Outcome Measures

Name	Time	Method
Diagnosis of significant hepatic fibrosis	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	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	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)	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.
PRL	2019-2024	serum prolactin levels
Normal PRL (NP)	2019-2024	NP was defined as serum PRL \< 324mIU/L in males or \< 496mIU/L in females.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China