RecruitingNCT06542718

Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort

Studying the Heterogeneity of Gestational Diabetes Mellitus: Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore (GDM-CARE)


Sponsor

National University Health System, Singapore

Enrollment

800 participants

Start Date

Oct 3, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

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Locations(1)

Department of Obstetrics & Gynaecology

Singapore, Singapore

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NCT06542718


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