Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542718
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Studying the Heterogeneity of Gestational Diabetes Mellitus Cardio-Metabolic Alteration and Treatment Response in a Multi-Ethnic Population in Singapore GDM-CARE
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GDM-CARE
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
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
Detailed Description:
The transient hyperglycemia first identified during pregnancy is known as gestational diabetes mellitus GDM GDM increases the risks of adverse pregnancy and neonatal outcomes such as pre-eclampsia and macrosomia Due to the widespread prevalence of overweight obesity and genetic susceptibility GDM is more common among Asian pregnant women-occurring 2- to 3-fold more frequently compared to European pregnant women with rates ranging from 15 to 30 in individuals of Chinese and Indian descent
Emerging evidence suggests that variations in insulin sensitivity fat deposition and β-cell activity may contribute to the heterogeneous phenotypes of GDM leading to different pregnancy outcomes and maternal diabetic progression However current clinical treatment and follow-up strategies for GDM typically adopt a one-size-fits-all approach ignoring the underlying pathophysiological variations among patients As a result the efficiency and efficacy of the current clinical approach during pregnancy and postpartum are suboptimal
In this study the investigators aim to define the heterogeneity of GDM in terms of in vivo cardio-metabolic profiling and treatment response during pregnancy using advanced technologies such as continuous glucose profiling and untargeted metabolite profiling The investigators hypothesize that a better clinical and molecular understanding of GDM phenotypes will enable tailored effective treatment strategies for individuals and aid in predicting and preventing postnatal abnormal glucose metabolism
This proposed 3-year longitudinal study will involve a cohort of 800 overweight 23-249 kgm² or obese 25 kgm² singleton pregnant women recruited no later than 12 weeks of gestation These women who are of Chinese Malay and Indian ethnicities will be recruited from the National University Hospital NUH in Singapore and will not have a history of diabetes All participants will be screened for GDM at 24-28 weeks of gestation and followed until delivery
The primary outcome will be the identification of GDM phenotype-specific continuous glycemic profiles and alterations in cardio-metabolic biomarkers The secondary outcome will focus on the treatment responses specific to different GDM phenotypes
Emerging evidence suggests that variations in insulin sensitivity fat deposition and β-cell activity may contribute to the heterogeneous phenotypes of GDM leading to different pregnancy outcomes and maternal diabetic progression However current clinical treatment and follow-up strategies for GDM typically adopt a one-size-fits-all approach ignoring the underlying pathophysiological variations among patients As a result the efficiency and efficacy of the current clinical approach during pregnancy and postpartum are suboptimal
In this study the investigators aim to define the heterogeneity of GDM in terms of in vivo cardio-metabolic profiling and treatment response during pregnancy using advanced technologies such as continuous glucose profiling and untargeted metabolite profiling The investigators hypothesize that a better clinical and molecular understanding of GDM phenotypes will enable tailored effective treatment strategies for individuals and aid in predicting and preventing postnatal abnormal glucose metabolism
This proposed 3-year longitudinal study will involve a cohort of 800 overweight 23-249 kgm² or obese 25 kgm² singleton pregnant women recruited no later than 12 weeks of gestation These women who are of Chinese Malay and Indian ethnicities will be recruited from the National University Hospital NUH in Singapore and will not have a history of diabetes All participants will be screened for GDM at 24-28 weeks of gestation and followed until delivery
The primary outcome will be the identification of GDM phenotype-specific continuous glycemic profiles and alterations in cardio-metabolic biomarkers The secondary outcome will focus on the treatment responses specific to different GDM phenotypes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None