The Extension of HAPO Follow-up Study

NCT ID: NCT05477511

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Ronald Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Chiu Wang

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, Hong Kong, China, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Chi Chiu Wang

Role: CONTACT

ccwang@cuhk.edu.hk

+852 35052804

Facility Contacts

Chi Chiu Wang

Role: primary

References

See protocol

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HAPO-005

Identifier Type: -

Identifier Source: org_study_id