GDM-CARENCT06542718

Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort

StatusActive, Not Recruiting

PhaseNot specified

SponsorNational University Health System, Singapore

Primary completionFeb 3, 2026

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 12, 2026 Eligibility criteria expanded, about 12 words Show 6 more changesShow less
- Enrollment closed, study ongoing
- Final enrollment: 528 participants (planned 800)
- Primary completion date changed from estimate of Jun 30, 2026 to Feb 3, 2026
- Study completion pushed from Jul 1, 2026 to Jun 2027
- Site details revised
- Publications: details revised at 4 of 4 entries
Notable May 25, 2025 Primary completion date: Sep 30, 2024 to Jun 30, 2026
- Study completion date: Dec 31, 2025 to Jul 1, 2026
v2
Aug 5, 2024 Study First Submitted

Notable: the plan changed

Endpoints

Primary

IADPSG (International Association of Diabetes and Pregnancy Study Groups)-defined Gestational Diabetes Mellitus (GDM)

Timeframe: 3 years

Secondary (1)

Rates of Diet or Insulin-treated gestational diabetes mellitus based on phenotypes

Sites

1 site in 1 country

Department of Obstetrics & GynaecologySingapore, Singapore, 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.

Trial details

Enrollment: 528 participants (actual)
Started: Oct 3, 2022
Study completion: Jun 2027 (estimated)
Eligibility: 21 to 45, female only, no healthy volunteers
Design: Observational
Oversight: Data monitoring committee
Conditions: Birth Weight, Diabetes Mellitus, Diabetes, Gestational, Insulin Resistance, Pregnancy Complications, Pregnancy Related, Insulin Resistance, Diabetes, Intergenerational Relations
Official title: Studying the Heterogeneity of Gestational Diabetes Mellitus: Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore (GDM-CARE)
First posted: Aug 7, 2024
Registry updated: Nov 13, 2026
Last verified: Nov 2026

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