Mechanism of Serum PRL in the Development of MAFLD

Type2 Diabetes Clinical Trial

Official title:

Mechanism of Serum PRL in the Development of MAFLD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525884
• Other study ID #: PRL
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 31, 2024

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: Shen Qu
• Phone: +862166301064
• Email: qushencn[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Cirrhosis
• Liver Fibrosis
• Non-alcoholic Fatty Liver Disease
• Type2 Diabetes

Intervention

Other:
• non-invasive method, Fibroscan
Liver Ultrasound and transient elastography (FibroScan®)

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shen Qu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PRL	serum prolactin levels	2019-2024
Primary	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
Primary	Normal PRL (NP)	NP was defined as serum PRL < 324mIU/L in males or < 496mIU/L in females.	2019-2024
Primary	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
Primary	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	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
Secondary	Hypertension	it was defined by blood pressure =130/85mmHg or antihypertensive drugs.	2019-2024
Secondary	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
Secondary	Overweight or obesity	it was defined as BMI = 23 kg/m2 in Asians.	2019-2024
Secondary	Abdominal obesity	It was diagnosed when WC = 90/80 cm in Asian men and women.	2019-2024
Secondary	T2DM	it was diagnosed according to the guideline for the prevention and treatment of T2DM in China (2020 edition)	2019-2024
Secondary	High CRP	plasma CRP > 2 mg/L	2019-2024
Secondary	High HOMA-IR	HOMA-IR= 2.5	2019-2024