NCT05477511

Brief Summary

The prevalence of diabetes mellitus (DM) and cardiovascular disease (CVD) escalate remarkably worldwide and obesity becomes an epidemic disease. This study is interested in how the model of Developmental Origin of Health and Disease (DOHaD) influence individual's health status as they reach young adulthood. Since the mothers from HAPO study have not been subjected to antenatal treatment on the various degree of maternal hyperglycaemia in pregnancy, this would be an unique cohort that allows determination of the effect of various degree of maternal hyperglycaemia below the level of overt DM, on children's cardiometabolic risk in Chinese population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

4.3 years

First QC Date

July 21, 2022

Last Update Submit

September 21, 2023

Conditions

Keywords

HyperglycemiaPregnancyOvernutritionMaternal ObesityDiabetes MellitusCardiovascular DiseasesGestational Diabetes MellitusHypertensionYoung Adulthood

Outcome Measures

Primary Outcomes (1)

  • Rate of DM in the young adult offspring

    Study specimens would be collected to identify the rate of DM in young adult offspring.

    At a time around 18 years of age

Secondary Outcomes (1)

  • Rate of impaired glucose regulation, obesity and adiposity, hypertension and various insulin indices

    At a time around 18 years of age

Study Arms (2)

Mother

Chinese mother in Hong Kong who had been assessed in HAPO follow-up study when their children was at either 7 or 11-14 years of age

18 years old child of the enrolled mother

Children who had been assessed in HAPO follow-up study at either 7 or 11-14 years of age

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hong Kong women and their 18 year-old offspring

You may qualify if:

  • Mother-child pairs who had been assessed in HAPO follow-up study at either 7 years or 11-14 years old

You may not qualify if:

  • Children born preterm before 37 weeks of gestation
  • Non-Chinese
  • Mothers' OGTT results were unblinded during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China, Shatin, Hong Kong

RECRUITING

Related Publications (1)

  • See protocol

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood, OGTT blood

MeSH Terms

Conditions

HyperglycemiaOvernutritionDiabetes MellitusCardiovascular DiseasesHypertensionPregnancy in ObesityDiabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersEndocrine System DiseasesVascular DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chi Chiu Wang

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 28, 2022

Study Start

August 28, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations