Prolactin and FGF21 in Gestational Diabetes Mellitus

NCT ID: NCT05528393

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Gestational Diabetes Mellitus in Pregnancy Hyperprolactinemia Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GDM and Non-GDM

Blood sampling

Intervention Type DIAGNOSTIC_TEST

blood sampling

Pregnant group and non-pregnant group

Blood sampling

Intervention Type DIAGNOSTIC_TEST

blood sampling

Interventions

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Blood sampling

blood sampling

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shen Qu

OTHER

Sponsor Role lead

Responsible Party

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Shen Qu

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shen Qu, PhD

Role: primary

+862166301064

Other Identifiers

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gestational diabetes mellitus

Identifier Type: -

Identifier Source: org_study_id

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