The Extension of HAPO Follow-up Study

Recruiting

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

• Registration Number: NCT05477511
• Lead Sponsor: Chinese University of Hong Kong

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.

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.

Study Timeline

• Study Start: 2020-08-28
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of DM in the young adult offspring	At a time around 18 years of age	Study specimens would be collected to identify the rate of DM in young adult offspring.

Secondary Outcome Measures

Name	Time	Method
Rate of impaired glucose regulation, obesity and adiposity, hypertension and various insulin indices	At a time around 18 years of age	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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong, China, Hong Kong