Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-45
SponsorNational University Health System, Singapore

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
3 years

Other outcomes

1

Rate of large-for-gestational age (LGA) babies based on GDM phenotypes

The numbers and rates of LGA babies according to different GDM phenotypes will be calculated.

Time frame
3 year

Sponsors and contacts

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