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

NCT ID: NCT05148130

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2023-09-11

Brief Summary

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.

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.

Conditions

Gestational Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

oral glucose tolerance test

Intervention Type: DIAGNOSTIC_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

oral glucose tolerance test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Q Wang

Role: STUDY_DIRECTOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Zhenjiang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Q Wang

Role: CONTACT

Phone: +86-15868448702

Email: wangliquan@zju.edu.cn

Jing W Xu

Role: CONTACT

Phone: +86-15168257495

Email: 2516095@zju.edu.cn

Facility Contacts

Li Q Wang

Role: primary

Other Identifiers

2018-121

Identifier Type: -

Identifier Source: org_study_id