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

• ClinicalTrials.gov Identifier: NCT05148130
• Recruitment Status: Unknown
• 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

Tracking Information

• First Submitted Date: June 27, 2021
• First Posted Date: December 8, 2021
• Last Update Posted Date: December 8, 2021
• Actual Study Start Date: September 11, 2018
• Estimated Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2021)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus
• Official Title: Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year

Biospecimen

Retention:   Samples With DNA

Description:

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

• 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。
• Condition: Gestational Diabetes

Intervention

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.

Study Groups/Cohorts

• 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.
  Intervention: Diagnostic Test: oral glucose tolerance test
• 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
  Intervention: Diagnostic Test: oral glucose tolerance test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 6, 2021): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 11, 2023
• Estimated Primary Completion Date: September 11, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05148130
• Other Study ID Numbers: 2018-121
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

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。

• Current Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Original Responsible Party: Same as current
• Current Study Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Verification Date: June 2021