Prolactin and FGF21 in Gestational Diabetes Mellitus

September 2, 2022 updated by: Shen Qu
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who met the above criteria were enrolled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GDM and Non-GDM
Diagnostic test: Blood sampling
blood sampling
Pregnant group and non-pregnant group
Diagnostic test: Blood sampling
blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational diabetes mellitus (GDM)
Time Frame: 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.
2019-2023
PRL
Time Frame: 2019-2023
serum prolactin level
2019-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance (IR)
Time Frame: 2019-2023
It was considered to be IR if HOMA-IR >2.5
2019-2023
HOMA-IR
Time Frame: 2019-2023
It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5
2019-2023
OGTT
Time Frame: 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.
2019-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shen Qu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gestational diabetes mellitus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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