NCT06542718 Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort
| NCT ID | NCT06542718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Health System, Singapore |
| Condition | Gestational Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-10-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-10-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06542718 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 45 Years, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06542718 currently recruiting?
Yes, NCT06542718 is actively recruiting participants. Contact the research team at obgllj@nus.edu.sg for enrollment information.
Where is the NCT06542718 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06542718 clinical trial?
NCT06542718 is sponsored by National University Health System, Singapore. The trial plans to enroll 800 participants.
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