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NCT05528393 Clinical Trial

Prolactin and FGF21 in Gestational Diabetes Mellitus

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:
Prolactin and FGF21 in Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05528393
Other study ID # gestational diabetes mellitus
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 1, 2022

Study information
Verified date September 2022
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
blood sampling

Locations
Country Name City State
China Shanghai Tenth People's Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shen Qu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary PRL serum prolactin level 2019-2023
Secondary Insulin resistance (IR) It was considered to be IR if HOMA-IR >2.5 2019-2023
Secondary HOMA-IR It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5 2019-2023
Secondary 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. 2019-2023
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