Mechanism of Serum PRL in the Development of MAFLD

NCT05525884 | Unknown

• 1 other identifier: PRL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2 Diabetes; Fatty Liver, Nonalcoholic; Liver Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Homeostasis model assessment of IR (HOMA-IR)

  2019-2024

• Hypertension

  2019-2024

• Dyslipidemia

  2019-2024

• Overweight or obesity

  2019-2024

• Abdominal obesity

  2019-2024

Study Arms (3)

MAFLD and Non-MAFLD

Other: non-invasive method, Fibroscan

Steatosis and Non-Steatosis

Other: non-invasive method, Fibroscan

Fibrosis and Non-Fibrosis

Other: non-invasive method, Fibroscan

Interventions

non-invasive method, Fibroscan OTHER

Liver Ultrasound and transient elastography (FibroScan®)

Fibrosis and Non-Fibrosis; MAFLD and Non-MAFLD; Steatosis and Non-Steatosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• aged 18\~65 years old,
• underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shen Qu: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Shen Qu

CONTACT

+862166301064; qushencn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: September 2, 2022
• Study Start: January 1, 2017
• Primary Completion: January 1, 2024
• Study Completion: January 31, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

CN (1)