Gestational DiabetesNCT04539288
Serum Biomarkers Associated With Postpartum T2DM in Women With GDM
An observational study of Gestational Diabetes, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 3,099 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2013to 30 May 2018
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: GDM Women.
Who may be able to join
- Women who were dignosed GDM.
- Women with singleton pregnancy.
- Give birth in the First Affiliated Hospital in Sun Yat-sen University.
Who cannot join
- Women who were diagnosed PGDM.
- Younger than 18 years old.
- Older than 45 years old.
- Multiple pregnancy.
- Diagnosed DM before.
- Complicationg other diseases, like hypertension, thyroid diseases, etc.
- Taking any drug affect glucose and lipid metabolism.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Pregnancy to Postpartum Transition of Serum Biomarkers in Women With Gestational Diabetes
Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM.
Read the detailed description
GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in the future than women without GDM. However, data on the factors associated with the development of T2DM in women with GDM are not widely available.
- Conditions
- Gestational Diabetes
- Keywords
- GDM, T2DM, NGT, lipids
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
There is no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus | Women who were diagnosed GDM in 24-28 gestation weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2DM
Women with GDM develop T2DM in postpartum.
Measured: 4-6 weeks.
Secondary outcomes (1)
IGT
Women with GDM were impaired glucose intolerance in postpartum.
Measured: 4-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 May 2013
- Primary completion30 May 2018
- Study completion30 May 2018
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 First Affiliated Hospital, Sun Yat-Sen UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 3,099 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Dongyu Wang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539288
- Sponsor's protocol ID
- 50102013
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2018
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy to Postpartum Transition of Serum Biomarkers in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04539288
- Acronym / sponsor ID
- 50102013
- Conditions
- Gestational Diabetes
- Keywords
- GDM, T2DM, NGT, lipids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,099 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 4 Sep 2020 (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 commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM.
Detailed description
GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in the future than women without GDM. However, data on the factors associated with the development of T2DM in women with GDM are not widely available.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus | – | –Women who were diagnosed GDM in 24-28 gestation weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- GDM Women.
Key inclusion criteria (3 listed)
- Women who were dignosed GDM.
- Women with singleton pregnancy.
- Give birth in the First Affiliated Hospital in Sun Yat-sen University.
Key exclusion criteria (7 listed)
- Women who were diagnosed PGDM.
- Younger than 18 years old.
- Older than 45 years old.
- Multiple pregnancy.
- Diagnosed DM before.
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 |
|---|---|---|
| There is no intervention in this study. | Other | Gestational diabetes mellitus |
Primary outcome
T2DM
Time frame: 4-6 weeks.
Women with GDM develop T2DM in postpartum.
1 secondary outcome
IGT
Time frame: 4-6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
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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.
Dongyu Wang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 First Affiliated Hospital, Sun Yat-Sen University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 7 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2DM (time frame: 4-6 weeks.). 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 7 Sep 2020.