Gestational DiabetesNCT05148130
Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2018to 11 Sep 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All of the subjects come from the Department of Obstetrics of Second Hospital Affiliateod to Zhejiang University Medical College, Hangzhou, Zhejiang Province。
Who may be able to join
- 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.
- If the patient is younger than 18 years old, consent from parents or guardians is required;
- Inclusion objects in line with the above sample sources;
- Signed the informed consent;
Who cannot join
- Refuse to sign the informed consent
- Severe mental symptoms, unable to cooperate with blood collection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Zhenjiang
Li Q Wang, +86-15868448702, wangliquan@zju.edu.cn
About this study
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.
Read the 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
- Being tested
- oral glucose tolerance test
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Diagnostic Test: oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose homeostasis levels
fasting plasma glucose, 1-hour plasma glucose and 2-hour plasma glucose in mmol/l
Measured: 1 year
genotype of GDM single gene polymorphism
genotype such as the Surfactant protein-D gene polymorphism rs721917 in Thr31Met
Measured: 1 year
blood biochemistry indices
such as the serum Surfactant protein-D protein levels in ng/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start11 Sep 2018
- Primary completion11 Sep 2022 (estimated)
- Study completion11 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Q Wang, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148130
- Sponsor's protocol ID
- 2018-121
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, we only share partial data of patients with gestational diabetes: blood glucose, BMI, age, fetal birth weight and other general features。
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05148130
- Acronym / sponsor ID
- 2018-121
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 11 Sep 2022 (estimated)
- Study completion
- 11 Sep 2023 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the gestational diabetes pregnant women group | – | Diagnostic Test: oral glucose tolerance testThe 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. |
| the healthy pregnant control group | – | Diagnostic Test: oral glucose tolerance testthe control group was pregnant women who delivered a single fetus at full term without complications and complications during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All of the subjects come from the Department of Obstetrics of Second Hospital Affiliateod to Zhejiang University Medical College, Hangzhou, Zhejiang Province。
Key inclusion criteria (4 listed)
- 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.
- If the patient is younger than 18 years old, consent from parents or guardians is required;
- Inclusion objects in line with the above sample sources;
- Signed the informed consent;
Key exclusion criteria (2 listed)
- Refuse to sign the informed consent
- Severe mental symptoms, unable to cooperate with blood collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glucose tolerance testGDM 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. | Diagnostic test | the gestational diabetes pregnant women group, the healthy pregnant control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided. At present, we only share partial data of patients with gestational diabetes: blood glucose, BMI, age, fetal birth weight and other general features。
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Q Wang study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Q Wang (+86-15868448702, wangliquan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose homeostasis levels (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.