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

• ClinicalTrials.gov Identifier: NCT05148130
• Recruitment Status: Recruiting
• First Posted: December 8, 2021
• Last Update Posted: December 8, 2021
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Information provided by (Responsible Party): Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description

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.

Condition or disease	Intervention/treatment
Gestational Diabetes	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Official Title: Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus
• Actual Study Start Date: September 11, 2018
• Estimated Primary Completion Date: September 11, 2022
• Estimated Study Completion Date: September 11, 2023

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

maternal peripheral blood; blood serum after centrifugation; DNA extracted from the peripheral blood; umbilical cord blood; the placenta tissue

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• 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。

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

Contacts and Locations

Contacts

Contact: Li Q Wang; +86-15868448702; wangliquan@zju.edu.cn

Contact: Jing W Xu; +86-15168257495; 2516095@zju.edu.cn

Locations

China

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

Zhenjiang, China

Contact: Li Q Wang +86-15868448702 wangliquan@zju.edu.cn

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

More Information

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05148130
• Other Study ID Numbers: 2018-121
• First Posted: December 8, 2021
• Last Update Posted: December 8, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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。

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases