Gestational DiabetesGDM-CARENCT06542718
Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort
An observational study of Gestational Diabetes and Pregnancy Related, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
Gestational diabetes mellitus (GDM) is a transient hyperglycemic condition identified during pregnancy in women without a history of chronic diabetes. Evidence indicates that GDM can lead to various adverse health outcomes, including preterm birth, progression to pre-diabetes, and type 2 diabetes after delivery in… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy Related, Pregnancy Complications
- How many people
- 800 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Oct 2022to 1 Jul 2026
- 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This is a prospective longitudinal study conducted at the Singapore National University Hospital (NUH) Obstetrics and Gynecology outpatient clinic. A cohort of 800 pregnant women will be recruited at NUH over a period of 18 months. The study involves 800 overweight (23-24.9 kg/m²) or obese (≥25 kg/m²) singleton pregnant women-without a history of diabetes and comprising Chinese, Malay, and Indian ethnicities-during their first trimester at the National University Hospital (NUH) in Singapore. All participants will be recruited no later than 12 weeks of gestation and screened for GDM between 24 and 28 weeks of gestation. The investigators will then follow up with the women diagnosed with GDM (approximately 200) from 32-34 weeks of gestation until delivery.
Who may be able to join
- Gestational age of ≤ 13 weeks 6 days
- Overweight and obese subjects with BMI of 23kg/m² - 24.9kg/m² and ≥ 25.0kg/m², respectively
- Aged 21-45 years with singleton pregnancy
- Plan to be followed up during the whole pregnancy and deliver at NUH
- Chinese, Malay or Indian ethnicity for pregnant subject
- Can complete questionnaires in English language
- Willing to wear continuous glucose monitoring device at least for 7 days at each required clinic visit
Who cannot join
- Participants who are not Singapore citizens or Singapore Permanent Residents, not intending to eventually deliver in Singapore National University Hospital and to reside in Singapore for the next 2 years
- Have serious skin conditions (eg. eczema) that precludes wearing the sensor for 14 days
- With history of Type 1 diabetes or Type 2 diabetes
- With chronic preexisting life-threatening conditions including pancreatic cancer, end-stage kidney dysfunction, and psychosis
- Unable to read or speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynaecology
Singapore, 117549
Ling-Jun Li, MD, PhD, 81000229, obgllj@nus.edu.sg
About this study
Official title: Studying the Heterogeneity of Gestational Diabetes Mellitus: Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore (GDM-CARE)
Gestational diabetes mellitus (GDM) is a transient hyperglycemic condition identified during pregnancy in women without a history of chronic diabetes. Evidence indicates that GDM can lead to various adverse health outcomes, including preterm birth, progression to pre-diabetes, and type 2 diabetes after delivery in mothers. Notably, GDM is becoming increasingly prevalent among Asian pregnant women due to rising rates of overweight and obesity, as well as genetic susceptibility. Despite growing recognition of GDM, its treatment efficiency and efficacy remain poor, primarily due to its heterogeneity, which is underpinned by various pathophysiological mechanisms.
Therefore, a better understanding of GDM heterogeneity can aid clinicians in providing more targeted treatment and follow-up strategies for GDM mothers. This study aims to define GDM phenotypes based on in vivo cardio-metabolic profiles and treatment response during pregnancy, utilizing advanced technologies such as continuous glucose profiling and untargeted metabolite profiling. In this proposed 3-year pregnancy cohort study, the investigators will recruit 800 overweight or obese Asian pregnant women in early pregnancy, without a history of diabetes, and follow them through to delivery. The goal of the study is to develop systematic antenatal and postnatal screening, treatment, and intervention guidelines for mothers with GDM.
Read the detailed description
The transient hyperglycemia first identified during pregnancy is known as gestational diabetes mellitus (GDM). GDM increases the risks of adverse pregnancy and neonatal outcomes, such as pre-eclampsia and macrosomia. Due to the widespread prevalence of overweight, obesity, and genetic susceptibility, GDM is more common among Asian pregnant women-occurring 2- to 3-fold more frequently compared to European pregnant women, with rates ranging from 15% to 30% in individuals of Chinese and Indian descent.
Emerging evidence suggests that variations in insulin sensitivity, fat deposition, and β-cell activity may contribute to the heterogeneous phenotypes of GDM, leading to different pregnancy outcomes and maternal diabetic progression. However, current clinical treatment and follow-up strategies for GDM typically adopt a "one-size-fits-all" approach, ignoring the underlying pathophysiological variations among patients. As a result, the efficiency and efficacy of the current clinical approach during pregnancy and postpartum are suboptimal.
In this study, the investigators aim to define the heterogeneity of GDM in terms of in vivo cardio-metabolic profiling and treatment response during pregnancy, using advanced technologies such as continuous glucose profiling and untargeted metabolite profiling. The investigators hypothesize that a better clinical and molecular understanding of GDM phenotypes will enable tailored, effective treatment strategies for individuals and aid in predicting and preventing postnatal abnormal glucose metabolism.
This proposed 3-year longitudinal study will involve a cohort of 800 overweight (23-24.9 kg/m²) or obese (≥25 kg/m²) singleton pregnant women, recruited no later than 12 weeks of gestation. These women, who are of Chinese, Malay, and Indian ethnicities, will be recruited from the National University Hospital (NUH) in Singapore and will not have a history of diabetes. All participants will be screened for GDM at 24-28 weeks of gestation and followed until delivery.
The primary outcome will be the identification of GDM phenotype-specific continuous glycemic profiles and alterations in cardio-metabolic biomarkers. The secondary outcome will focus on the treatment responses specific to different GDM phenotypes.
- Conditions
- Gestational Diabetes, Pregnancy Related, Pregnancy Complications, Birth Weight, Insulin Resistance, Diabetes, Intergenerational Relations
- Keywords
- Pregnancy
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications, Birth Weight, Insulin Resistance, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
IADPSG (International Association of Diabetes and Pregnancy Study Groups)-defined Gestational Diabetes Mellitus (GDM)
Oral Glucose Tolerance Test (OGTT) will be performed during universal screening at 24-28 weeks of gestational age. 0, 1 hour and 2 hour glucose readings will be measured after 8-10 hours of overnight fasting, after a 75 grams glucose drink. Cutoffs are according to The International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines.
Measured: 3 years
Secondary outcomes (1)
Rates of Diet or Insulin-treated gestational diabetes mellitus based on phenotypes
The rates of treatment-specific gestational diabetes phenotypes will be calculated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start3 Oct 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjun Li, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542718
- Sponsor's protocol ID
- 2021/01076
- Acronym
- GDM-CARE
- Status last verified
- May 2025
- First submitted
- 27 Jul 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be shared based on write-in proposal to the PI.
Publications
McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
PubMed 31296866Chong YS, Cai S, Lin H, Soh SE, Lee YS, Leow MK, Chan YH, Chen L, Holbrook JD, Tan KH, Rajadurai VS, Yeo GS, Kramer MS, Saw SM, Gluckman PD, Godfrey KM, Kwek K; GUSTO study group. Ethnic differences translate to inadequacy of high-risk screening for gestational diabetes mellitus in an Asian population: a cohort study. BMC Pregnancy Childbirth. 2014 Oct 2;14:345. doi: 10.1186/1471-2393-14-345.
PubMed 25273851Yu Q, Aris IM, Tan KH, Li LJ. Application and Utility of Continuous Glucose Monitoring in Pregnancy: A Systematic Review. Front Endocrinol (Lausanne). 2019 Oct 11;10:697. doi: 10.3389/fendo.2019.00697. eCollection 2019.
PubMed 31681170Powe CE, Hivert MF, Udler MS. Defining Heterogeneity Among Women With Gestational Diabetes Mellitus. Diabetes. 2020 Oct;69(10):2064-2074. doi: 10.2337/dbi20-0004. Epub 2020 Aug 25.
PubMed 32843565
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Heterogeneity of Gestational Diabetes Mellitus: Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore (GDM-CARE)
- ClinicalTrials.gov ID
- NCT06542718
- Acronym / sponsor ID
- GDM-CARE / 2021/01076
- Conditions
- Gestational Diabetes, Pregnancy Related, Pregnancy Complications, Birth Weight, Insulin Resistance, Diabetes, Intergenerational Relations
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 7 Aug 2024 (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 transient hyperglycemic condition identified during pregnancy in women without a history of chronic diabetes. Evidence indicates that GDM can lead to various adverse health outcomes, including preterm birth, progression to pre-diabetes, and type 2 diabetes after delivery in mothers. Notably, GDM is becoming increasingly prevalent among Asian pregnant women due to rising rates of overweight and obesity, as well as genetic susceptibility. Despite growing recognition of GDM, its treatment efficiency and efficacy remain poor, primarily due to its heterogeneity, which is underpinned by various pathophysiological mechanisms.
Therefore, a better understanding of GDM heterogeneity can aid clinicians in providing more targeted treatment and follow-up strategies for GDM mothers. This study aims to define GDM phenotypes based on in vivo cardio-metabolic profiles and treatment response during pregnancy, utilizing advanced technologies such as continuous glucose profiling and untargeted metabolite profiling. In this proposed 3-year pregnancy cohort study, the investigators will recruit 800 overweight or obese Asian pregnant women in early pregnancy, without a history of diabetes, and follow them through to delivery. The goal of the study is to develop systematic antenatal and postnatal screening, treatment, and intervention guidelines for mothers with GDM.
Detailed description
The transient hyperglycemia first identified during pregnancy is known as gestational diabetes mellitus (GDM). GDM increases the risks of adverse pregnancy and neonatal outcomes, such as pre-eclampsia and macrosomia. Due to the widespread prevalence of overweight, obesity, and genetic susceptibility, GDM is more common among Asian pregnant women-occurring 2- to 3-fold more frequently compared to European pregnant women, with rates ranging from 15% to 30% in individuals of Chinese and Indian descent.
Emerging evidence suggests that variations in insulin sensitivity, fat deposition, and β-cell activity may contribute to the heterogeneous phenotypes of GDM, leading to different pregnancy outcomes and maternal diabetic progression. However, current clinical treatment and follow-up strategies for GDM typically adopt a "one-size-fits-all" approach, ignoring the underlying pathophysiological variations among patients. As a result, the efficiency and efficacy of the current clinical approach during pregnancy and postpartum are suboptimal.
In this study, the investigators aim to define the heterogeneity of GDM in terms of in vivo cardio-metabolic profiling and treatment response during pregnancy, using advanced technologies such as continuous glucose profiling and untargeted metabolite profiling. The investigators hypothesize that a better clinical and molecular understanding of GDM phenotypes will enable tailored, effective treatment strategies for individuals and aid in predicting and preventing postnatal abnormal glucose metabolism.
This proposed 3-year longitudinal study will involve a cohort of 800 overweight (23-24.9 kg/m²) or obese (≥25 kg/m²) singleton pregnant women, recruited no later than 12 weeks of gestation. These women, who are of Chinese, Malay, and Indian ethnicities, will be recruited from the National University Hospital (NUH) in Singapore and will not have a history of diabetes. All participants will be screened for GDM at 24-28 weeks of gestation and followed until delivery.
The primary outcome will be the identification of GDM phenotype-specific continuous glycemic profiles and alterations in cardio-metabolic biomarkers. The secondary outcome will focus on the treatment responses specific to different GDM phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a prospective longitudinal study conducted at the Singapore National University Hospital (NUH) Obstetrics and Gynecology outpatient clinic. A cohort of 800 pregnant women will be recruited at NUH over a period of 18 months. The study involves 800 overweight (23-24.9 kg/m²) or obese (≥25 kg/m²) singleton pregnant women-without a history of diabetes and comprising Chinese, Malay, and Indian ethnicities-during their first trimester at the National University Hospital (NUH) in Singapore. All participants will be recruited no later than 12 weeks of gestation and screened for GDM between 24 and 28 weeks of gestation. The investigators will then follow up with the women diagnosed with GDM (approximately 200) from 32-34 weeks of gestation until delivery.
Key inclusion criteria (7 listed)
- Gestational age of ≤ 13 weeks 6 days
- Overweight and obese subjects with BMI of 23kg/m² - 24.9kg/m² and ≥ 25.0kg/m², respectively
- Aged 21-45 years with singleton pregnancy
- Plan to be followed up during the whole pregnancy and deliver at NUH
- Chinese, Malay or Indian ethnicity for pregnant subject
Key exclusion criteria (5 listed)
- Participants who are not Singapore citizens or Singapore Permanent Residents, not intending to eventually deliver in Singapore National University Hospital and to reside in Singapore for the next 2 years
- Have serious skin conditions (eg. eczema) that precludes wearing the sensor for 14 days
- With history of Type 1 diabetes or Type 2 diabetes
- With chronic preexisting life-threatening conditions including pancreatic cancer, end-stage kidney dysfunction, and psychosis
- Unable to read or speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IADPSG (International Association of Diabetes and Pregnancy Study Groups)-defined Gestational Diabetes Mellitus (GDM)
Time frame: 3 years
Oral Glucose Tolerance Test (OGTT) will be performed during universal screening at 24-28 weeks of gestational age. 0, 1 hour and 2 hour glucose readings will be measured after 8-10 hours of overnight fasting, after a 75 grams glucose drink. Cutoffs are according to The International Association of Diabetes and Pregnancy Study Groups (IADPSG) guidelines.
1 secondary outcome
Rates of Diet or Insulin-treated gestational diabetes mellitus based on phenotypes
Time frame: 3 years
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 28 May 2025.
- Background: PubMed 31296866McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
- Background: PubMed 25273851Chong YS, Cai S, Lin H, Soh SE, Lee YS, Leow MK, Chan YH, Chen L, Holbrook JD, Tan KH, Rajadurai VS, Yeo GS, Kramer MS, Saw SM, Gluckman PD, Godfrey KM, Kwek K; GUSTO study group. Ethnic differences translate to inadequacy of high-risk screening for gestational diabetes mellitus in an Asian population: a cohort study. BMC Pregnancy Childbirth. 2014 Oct 2;14:345. doi: 10.1186/1471-2393-14-345.
- Background: PubMed 31681170Yu Q, Aris IM, Tan KH, Li LJ. Application and Utility of Continuous Glucose Monitoring in Pregnancy: A Systematic Review. Front Endocrinol (Lausanne). 2019 Oct 11;10:697. doi: 10.3389/fendo.2019.00697. eCollection 2019.
- Background: PubMed 32843565Powe CE, Hivert MF, Udler MS. Defining Heterogeneity Among Women With Gestational Diabetes Mellitus. Diabetes. 2020 Oct;69(10):2064-2074. doi: 10.2337/dbi20-0004. Epub 2020 Aug 25.
- Individual participant dataSharing planned: No. Individual participant data will only be shared based on write-in proposal to the PI.
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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.
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 and Pregnancy Related, run by National University Health System, Singapore at 1 site in Singapore.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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 Singapore. 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?
Contact Ling-Jun Li, MD, PhD (81000229, obgllj@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IADPSG (International Association of Diabetes and Pregnancy Study Groups)-defined Gestational Diabetes Mellitus (GDM) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542718, which also lists 4 linked publications.
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 28 May 2025.