Prolactin and FGF21 in Gestational Diabetes Mellitus

NCT05528393 | Unknown

• 1 other identifier: gestational diabetes mellitus
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Hyperprolactinemia Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  2019-2023

• PRL

  serum prolactin level

  2019-2023

Secondary Outcomes (3)

• Insulin resistance (IR)

  2019-2023

• HOMA-IR

  2019-2023

• OGTT

  2019-2023

Study Arms (2)

GDM and Non-GDM

Diagnostic Test: Blood sampling

Pregnant group and non-pregnant group

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

blood sampling

GDM and Non-GDM; Pregnant group and non-pregnant group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who met the above criteria were enrolled

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shen Qu: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, 200072, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 6, 2022
• Study Start: January 1, 2017
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

CN (1)