Prolactin and FGF21 in Gestational Diabetes Mellitus

Shen Qu200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Gestational Diabetes Mellitus in Pregnancy Hyperprolactinemia Pregnancy

Interventions

Blood samplingDIAGNOSTIC_TEST

blood sampling

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Tenth People's Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Gestational diabetes mellitus (GDM)

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.

Time frame: 2019-2023

PRL

serum prolactin level

Time frame: 2019-2023

Secondary Outcomes

Insulin resistance (IR)

It was considered to be IR if HOMA-IR \>2.5

Time frame: 2019-2023

HOMA-IR

It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5

Time frame: 2019-2023

OGTT

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.

Time frame: 2019-2023

Data from ClinicalTrials.gov

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