Gestational DiabetesNCT05632055
miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21) Profile in First Trimester and Gestational Diabetes Prediction
An observational study of Gestational Diabetes, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups. Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- blood draw
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- 26 Aug 2000to 17 Mar 2026
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy pregnant women with single alive fetus Participants will be subgroup based on the result of 100gm OGTT
Who may be able to join
- singleton pregnant women who attend at our clinic in first trimester
Who cannot join
- known underlying disease such as chronic hypertension, pregestational diabetes, SLE
- normal structural fetal anatomical screening
- incomplete obstetric data
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, ChiangMai, 50200
About this study
Official title: miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes
The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups.
Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.
Read the detailed description
Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited.
Participants received routine standard prenatal care except,
- additional blood test during 11-13 week 6 days (Blood was collected for further analysis)
- performed 75gm OGTT during 24-28 week
Baseline data and pregnancy outcome were reviewed.
- Conditions
- Gestational Diabetes
- Being tested
- blood draw
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy with GDM | Pregnant women who positive test for 100gm OGTT (abnormal 2 or more blood glucose level according NDDG (National Diabetes Data Group) criteria) Receives: Other: blood draw | |
| Pregnancy without GDM | Pregnant women who negative test for 100gm OGTT Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA profile
miRNA profile in first trimester of pregnancy and efficacy for GDM prediction
Measured: within 1 month after blood drawn
Secondary outcomes (1)
FGF21 profile
FGF21 profile in first trimester of pregnancy and efficacy for GDM prediction
Measured: 6 months after blood drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start26 Aug 2000
- Primary completion21 Nov 2022
- Study completion17 Mar 2026 (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.
- 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
- 160 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuntharee Traisrisilp, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632055
- Sponsor's protocol ID
- OBG-2563-07494
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05632055
- Acronym / sponsor ID
- OBG-2563-07494
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 26 Aug 2000 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 17 Mar 2026 (estimated)
- First posted
- 30 Nov 2022 (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.
The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups.
Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.
Detailed description
Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited.
Participants received routine standard prenatal care except,
- additional blood test during 11-13 week 6 days (Blood was collected for further analysis)
- performed 75gm OGTT during 24-28 week
Baseline data and pregnancy outcome were reviewed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy with GDM | – | Other: blood drawPregnant women who positive test for 100gm OGTT (abnormal 2 or more blood glucose level according NDDG (National Diabetes Data Group) criteria) |
| Pregnancy without GDM | – | Other: blood drawPregnant women who negative test for 100gm OGTT |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy pregnant women with single alive fetus Participants will be subgroup based on the result of 100gm OGTT
Key inclusion criteria (1 listed)
- singleton pregnant women who attend at our clinic in first trimester
Key exclusion criteria (3 listed)
- known underlying disease such as chronic hypertension, pregestational diabetes, SLE
- normal structural fetal anatomical screening
- incomplete obstetric data
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 |
|---|---|---|
| blood drawBlood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management | Other | Pregnancy with GDM, Pregnancy without GDM |
Primary outcome
miRNA profile
Time frame: within 1 month after blood drawn
miRNA profile in first trimester of pregnancy and efficacy for GDM prediction
1 secondary outcome
FGF21 profile
Time frame: 6 months after blood drawn
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chiang Mai University at 1 site in Thailand.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
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?
miRNA profile (time frame: within 1 month after blood drawn). 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 18 Mar 2026.