Understanding Gestational Diabetes in Asian Pregnant Women
Studying the Heterogeneity of Gestational Diabetes Mellitus: Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore (GDM-CARE)
This study is trying to learn more about gestational diabetes in Asian pregnant women to see how different types of the condition affect their health and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | National University Health System, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06542718 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on gestational diabetes mellitus (GDM), a condition that affects pregnant women and can lead to serious health issues for both mothers and babies. It aims to identify different phenotypes of GDM among Asian women by analyzing their cardio-metabolic profiles and treatment responses during pregnancy. Utilizing advanced technologies like continuous glucose monitoring and metabolite profiling, the study seeks to provide insights that could lead to more personalized treatment strategies for managing GDM. By understanding the heterogeneity of GDM, the researchers hope to improve clinical outcomes for affected mothers and their children.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese pregnant women of Chinese, Malay, or Indian ethnicity, aged 21-45, who are within the first trimester of pregnancy.
Not a fit: Patients who are not Singapore citizens or permanent residents, or those with a history of Type 1 or Type 2 diabetes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored treatment strategies for managing gestational diabetes in pregnant women.
How similar studies have performed: While the approach of defining GDM phenotypes is innovative, similar studies have shown promise in understanding the complexities of gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- Department of Obstetrics & Gynaecology — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Ling-Jun Li, MD, PhD
- Email: obgllj@nus.edu.sg
- Phone: 81000229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.