Mechanism of Serum PRL in the Development of MAFLD

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 Overview

• Status: Recruiting
• Conditions: Type2 Diabetes; Liver Fibrosis; Fatty Liver, Nonalcoholic
• Intervention / Treatment: Other: non-invasive method, Fibroscan

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Shen Qu; Phone Number: +862166301064; Email: qushencn@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Shen Qu, PHD; Phone Number: +8613636600255; Email: qushencn@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with T2DM who met the inclusion and criteria criteria were consecutively enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MAFLD and Non-MAFLD	Other: non-invasive method, Fibroscan; Liver Ultrasound and transient elastography (FibroScan®)
Steatosis and Non-Steatosis	Other: non-invasive method, Fibroscan; Liver Ultrasound and transient elastography (FibroScan®)
Fibrosis and Non-Fibrosis	Other: non-invasive method, Fibroscan; Liver Ultrasound and transient elastography (FibroScan®)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shen Qu

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 31, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (ACTUAL): September 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Prolactin; Metabolic associated fatty liver disease,
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Liver Diseases; Fibrosis; Diabetes Mellitus, Type 2; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PRL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No