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Prolactin and FGF21 in Gestational Diabetes Mellitus

Prolactin and FGF21 in Gestational Diabetes Mellitus

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05528393
Enrollment
200
Registered
2022-09-06
Start date
2017-01-01
Completion date
2022-12-01
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus in Pregnancy, Hyperprolactinemia Pregnancy

Keywords

Gestational Diabetes Mellitus, Prolactin, Insulin resistance, Fibroblast growth factor 21

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.

Interventions

DIAGNOSTIC_TESTBlood sampling

blood sampling

Sponsors

Shen Qu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gestational diabetes mellitus (GDM)2019-2023GDM 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.
PRL2019-2023serum prolactin level

Secondary

MeasureTime frameDescription
Insulin resistance (IR)2019-2023It was considered to be IR if HOMA-IR \>2.5
HOMA-IR2019-2023It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5
OGTT2019-2023OGTT 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026