Hong Kong Gestational Diabetes Register (HKGDR)

NCT07271407 | Enrolling By Invitation DMC

• 1 other identifier: 2025.200
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational diabetes mellitus (GDM) is a common condition that affects approximately one out of every six pregnancies. It is defined by elevated levels of blood glucose during pregnancy, usually detected through a glucose challenge test conducted at approximately 24-28 weeks of gestation. Gestational diabetes, by nature of the elevated glucose levels during pregnancy, is known to be linked to an increased risk of some conditions in the mother. Furthermore, the elevated glucose, if not well controlled, can be linked to a higher birth weight in the baby, as well as other effects. Although it is known that women with gestational diabetes have higher risks of diabetes later in life, exactly why gestational diabetes increases the risk of diabetes is not entirely known. It is known that some of the genetic factors that are linked to gestational diabetes are also linked to diabetes risk. Furthermore, how elevated glucose during pregnancy may affect later generations is not entirely clear. This is a research study that aims to improve the postnatal follow-up of women with gestational diabetes. Currently, there are no standard recommendations on how women with gestational diabetes should be followed up after they have given birth. Furthermore, despite being at increased risk of other metabolic problems including high blood pressure, abnormal lipids, and obesity, these are not routinely being monitored after gestational diabetes. The study aims to enroll women with gestational diabetes into a multi-center registry, where they will be provided with information about the long-term risks of metabolic diseases and be reminded to undergo regular assessments to monitor their health status, including assessment of glucose status, monitoring of blood pressure, as well as other parameters. Regular assessments will be provided for the initial 3 years. A subgroup of participants will also be invited to participate in a separate study of a lifestyle intervention program to reduce their risk of developing diabetes. It is hoped that results from this study will help guide the development of care programs to better monitor the health of women after pregnancies complicated by gestational diabetes, which will help improve the overall health of the population. In addition, the study aims to identify clinical factors, genetic and other biological biomarkers, as well as algorithms to predict different clinical outcomes and categorize participants into different subtypes of gestational diabetes, in order to optimize future treatments according to the characteristics of each individual.

Conditions

Gestational Diabetes Mellitus (GDM); GDM

Keywords

Gestational Diabetes Mellitus (GDM); Non-communicable diseases; Biomarkers; Genomics; Dysglycaemia; Diabetes; GDM

Outcome Measures

Primary Outcomes (1)

• Attendance rates of OGTT

  Baseline, 1 Year, 2 Year, 3 Year

Secondary Outcomes (10)

• Plasma glucose levels and rates of glucose intolerance

  1 Year, 2 Year, 3 Year

• Rate of abnormal glucose tolerance by OGTT

  1 Year, 2 Year, 3 Year

• Fat percentage, adiposity measures by bioimpendence analysis

  1 Year, 2 Year, 3 Year

• Insulin sensitivity (HOMA-IR)

  1 Year, 2 Year, 3 Year

• Insulin secretion (Insulinogenic index )

  1 Year, 2 Year, 3 Year

Study Arms (1)

Gestational diabetes

Women diagnosed with gestational diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with GDM will be identified through the diabetes and endocrine centre, antenatal GDM clinics and also antenatal and postnatal wards.

You may qualify if:

• Women diagnosed with gestational diabetes according to the IADPSG/WHO criteria, or other locally applicable criteria, during the index pregnancy
• Age 18-50
• Singleton pregnancy
• Willingness, ability and commitment to comply with study procedures
• In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
• Normally residing in Hong Kong
• Able to communicate in Chinese
• Written informed consent to participate in the study provided by the patient.
• Willing to return for postnatal glycemic assessment and follow-up
• Able to provide informed consent

You may not qualify if:

• Known current diabetes
• Current or previous use of glucose-lowering or weight loss drugs at screening
• Concurrent participation in other weight loss or lifestyle intervention programmes
• Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
• Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
• Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
• Known uncontrolled thyrotoxicosis
• Current use of steroids
• Known current or recent alcohol or drug abuse
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat, plasma, serum

MeSH Terms

Conditions

Diabetes, Gestational; Noncommunicable Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

HK (1)