Prolactin and FGF21 in Gestational Diabetes Mellitus

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy; Hyperprolactinemia Pregnancy

• Registration Number: NCT05528393
• Lead Sponsor: Shen Qu

Brief Summary

Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2022-09
• Primary Completion: 2022-09-01
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• aged 18 to 45 years
• completed a 75-g oral glucose tolerance test (OGTT)
• females with pregnancy

Exclusion Criteria

• severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
• mental illness
• genetic disease
• current or previous treatment that might affect PRL and insulin secretion
• diabetes before pregnancy
• loss to follow-up, or withdrawal from the study
• unable to understand and comply with the study protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational diabetes mellitus (GDM)	2019-2023	GDM is defined as a glucose intolerance resulting in hyperglycaemia of variable severity with onset during pregnancy. It can be diagnosed by the criteria: a fasting plasma glucose (FPG) concentration of O126 mg/dl on two separate occasions or a random blood glucose concentration of O200 mg/dl on two separate occasions.
PRL	2019-2023	serum prolactin level

Secondary Outcome Measures

Name	Time	Method
Insulin resistance (IR)	2019-2023	It was considered to be IR if HOMA-IR \>2.5
HOMA-IR	2019-2023	It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5
OGTT	2019-2023	OGTT was performed after an overnight fasting in each patient and blood samples were taken at 0, 30, 60, 120, and 180 min to determine the concentrations of plasma glucose.

Trial Locations

Locations (1)

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