Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is a type of diabetes mellitus with normal glucose metabolism before pregnancy. Pregnant women with prepubertal diabetes have complicated clinical experiences, and the effects of severe disease or poor glycemic control on mothers and infants. The incidence of gestational diabetes mellitus is very high, and the short-term and long-term complications of the mother and the child are higher. Through the detection of blood samples, we can not only obtain the basic information related to the disease such as blood cells and blood biochemistry, but also learn the important information such as enzymes, antibodies and cell metabolites in the blood that are conducive to the diagnosis of the disease. More importantly, blood contains genetic material (such as genomic DNA) that can be used to screen for genes and break down molecules. Placenta tissue examination can provide important cellular, biochemical, immunological and other information. However, due to the complex etiology of gestational diabetes. Especially associated with genetic or immunological factors, in the short term often cannot make a definite diagnosis, and patients in hospital time is limited, some check items such as gene detection, placental tissue can't complete them in hospital, need to return the patient's blood, cord blood and placenta tissue, to facilitate later further screening and biology research. This study intended to establish gestational diabetes patient's blood, cord blood and placenta tissue samples library, screening is closely related to the disease biomarkers, such as disease-causing gene mutations, susceptible gene mutation and protein metabolism product, so as to clarify disease relationship between genotype and clinical phenotype, the pathogenesis of diseases, etc., and provide the basis for the diagnosis of disease and treatment optimization.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Diagnostic test: oral glucose tolerance test

Detailed Description

the registry procedures: we collected data and blood samples from pregnant women diagnosed with GDM and matched healthy pregnant women as controls on the day admitted to hospital for delivery. All of the participants recruited were Han Chinese. Placental tissue was collected immediately after delivery and saved at -20 °C for analysis.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Li Q Wang; Phone Number: +86-15868448702; Email: wangliquan@zju.edu.cn
• Study Contact Backup: Name: Jing W Xu; Phone Number: +86-15168257495; Email: 2516095@zju.edu.cn

Study Locations

• China
  • Zhenjiang, China
    • Recruiting
    • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    • Contact: Li Q Wang; Phone Number: +86-15868448702; Email: wangliquan@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All of the subjects come from the Department of Obstetrics of Second Hospital Affiliateod to Zhejiang University Medical College, Hangzhou, Zhejiang Province。

Description

Inclusion Criteria:

1. The patient was older than 18 years old and had not been diagnosed with diabetes before pregnancy. A 75-gram glucose load examination was performed during 24-28 weeks of gestation：GDM should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting PG ≥5.1 mmol/l; 1-hour PG ≥10.0mmol/l; 2-hour PG 8.5-11.0 mmol/l.
2. If the patient is younger than 18 years old, consent from parents or guardians is required;
3. Inclusion objects in line with the above sample sources;
4. Signed the informed consent;

Exclusion Criteria:

1. Refuse to sign the informed consent
2. Severe mental symptoms, unable to cooperate with blood collection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the gestational diabetes pregnant women group; The diagnosis of GDM was established following the International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria. GDM should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting plasma glucose ≥5.1 mmol/l, 1-hour plasma glucose ≥10.0 mmol/l, and 2-hour plasma glucose of 8.5-11.0 mmol/l. Women diagnosed with DM or prediabetes (impaired fasting glucose or impaired glucose tolerance) before pregnancy were excluded from the study.	Diagnostic test: oral glucose tolerance test; GDM should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting plasma glucose ≥5.1 mmol/l; 1-hour plasma glucose ≥10.0mmol/l; 2-hour plasma glucose 8.5-11.0 mmol/l. Those women diagnosed with diabetes or pre-diabetes (impaired fasting glucose or impaired glucose tolerance) before pregnancy were excluded from the study.
the healthy pregnant control group; the control group was pregnant women who delivered a single fetus at full term without complications and complications during pregnancy	Diagnostic test: oral glucose tolerance test; GDM should be diagnosed at any time in pregnancy if one or more of the listed criteria are met following a 75-gram glucose load: fasting plasma glucose ≥5.1 mmol/l; 1-hour plasma glucose ≥10.0mmol/l; 2-hour plasma glucose 8.5-11.0 mmol/l. Those women diagnosed with diabetes or pre-diabetes (impaired fasting glucose or impaired glucose tolerance) before pregnancy were excluded from the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose homeostasis levels	fasting plasma glucose, 1-hour plasma glucose and 2-hour plasma glucose in mmol/l	1 year
genotype of GDM single gene polymorphism	genotype such as the Surfactant protein-D gene polymorphism rs721917 in Thr31Met	1 year
blood biochemistry indices	such as the serum Surfactant protein-D protein levels in ng/ml	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Li Q Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Anticipated): September 11, 2022
• Study Completion (Anticipated): September 11, 2023

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 2018-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At present, we only share partial data of patients with gestational diabetes: blood glucose, BMI, age, fetal birth weight and other general features。

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No