ClinicalTrials.gg
RecruitingNCT05477511Updated Sep 22, 2023

The Extension of HAPO Follow-up Study

An observational study in Hyperglycemia, Pregnancy and Overnutrition, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2020; still recruiting 6 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
900
Ages
16 Years and older
Sex
All
01

Study 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.

Read the detailed description

The investigators recruited 1760 Chinese pregnant women between 2000 and 2005. The HAPO study investigated whether any adverse outcome was associated with mild degree of GDM. All mothers underwent a 75-gram OGTT at 24-32 weeks gestation, but clinicians were blinded to the results as long as the fasting PG was ≤ 5.8 mmol/L \& 2-hour PG ≤ 11.1 mmol/L. The maternal serum C-peptide and HbA1c, cord serum C-peptide and early neonatal PG, pregnancy outcome and the neonatal anthropometric parameters are available for future study. This is so far the largest cohort in a Chinese population who has been investigated for glycaemia during pregnancy, but with OGTT results remained undisclosed to subjects and clinicians. This unique cohort can allow us to study the effect of in-utero hyperglycemia on the cardiometabolic risks at childhood, adolescence and adulthood.

Eligible subjects are all mother-child pairs participating in the original HAPO study. Children born preterm before 37 weeks of gestation, non-Chinese and whose mother's OGTT result were unblinded during pregnancy will be excluded.The family (the child and the mother) will be invited for a third follow-up assessment.

02

Conditions studied

  • Hyperglycemia
  • Pregnancy
  • Overnutrition
  • Maternal Obesity During Childbirth
  • Diabetes Mellitus
  • Cardiovascular Diseases
  • Gestational Diabetes Mellitus in Pregnancy
  • Hypertension

Keywords

  • Hyperglycemia
  • Pregnancy
  • Overnutrition
  • Maternal Obesity
  • Diabetes Mellitus
  • Cardiovascular Diseases
  • Gestational Diabetes Mellitus
  • Hypertension
  • Young Adulthood
03

In context

Hyperglycemia

800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.

This study's planned enrollment of 900 is above the median of 120 across 154 observational studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Hong Kong women and their 18 year-old offspring

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children born preterm before 37 weeks of gestation
  • Non-Chinese
  • Mothers' OGTT results were unblinded during pregnancy
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
900 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: At a time around 18 years of age

Secondary outcomes

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

    Study specimens would be collected to identify the percentage of impaired glucose regulation, obesity and adiposity, hypertension and various insulin indices in young adult offspring.

    Time frame: At a time around 18 years of age

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • See protocol

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2020 (actual). Primary completion is estimated for Dec 2024, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2022
First posted
Jul 28, 2022
StartActual
Aug 28, 2020
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Sep 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05477511
Responsible party
Ronald Wang (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jul 28, 2022
Start date
Aug 28, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 22, 2023

Study contacts

Chi Chiu Wang
Contact
ccwang@cuhk.edu.hk
+852 35052804
Chi Chiu Wang
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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