Studying Phenotypes of Gestational Diabetes Mellitus in an Asian Pregnant Cohort

NCT06542718 | Recruiting DMC

• 1 other identifier: 2021/01076
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Pregnancy Related; Pregnancy Complications; Birth Weight; Insulin Resistance, Diabetes; Intergenerational Relations

Keywords

Pregnancy

Outcome Measures

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.

  3 years

Secondary Outcomes (1)

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

  3 years

Other Outcomes (1)

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

  3 year

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Only pregnant subjects are recruited in the National University Hospital in Singapore.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

Department of Obstetrics & Gynaecology

Singapore, 117549, Singapore

RECRUITING

Related Publications (4)

• McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.

  PMID: 31296866 BACKGROUND

• Chong YS, Cai S, Lin H, Soh SE, Lee YS, Leow MK, Chan YH, Chen L, Holbrook JD, Tan KH, Rajadurai VS, Yeo GS, Kramer MS, Saw SM, Gluckman PD, Godfrey KM, Kwek K; GUSTO study group. Ethnic differences translate to inadequacy of high-risk screening for gestational diabetes mellitus in an Asian population: a cohort study. BMC Pregnancy Childbirth. 2014 Oct 2;14:345. doi: 10.1186/1471-2393-14-345.

  PMID: 25273851 BACKGROUND

• Yu Q, Aris IM, Tan KH, Li LJ. Application and Utility of Continuous Glucose Monitoring in Pregnancy: A Systematic Review. Front Endocrinol (Lausanne). 2019 Oct 11;10:697. doi: 10.3389/fendo.2019.00697. eCollection 2019.

  PMID: 31681170 BACKGROUND

• Powe CE, Hivert MF, Udler MS. Defining Heterogeneity Among Women With Gestational Diabetes Mellitus. Diabetes. 2020 Oct;69(10):2064-2074. doi: 10.2337/dbi20-0004. Epub 2020 Aug 25.

  PMID: 32843565 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and fecal samples will be collected across gestation.

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Birth Weight; Insulin Resistance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Central Study Contacts

Ling-Jun Li, MD, PhD

CONTACT

81000229; obgllj@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director, Public Affairs, Global Centre for Asian Women's Health, Assistant Professor, Department of O&G, Yong Loo Lin School of Medicine, National University of Singapore

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 7, 2024
• Study Start: October 3, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)