The Extension of HAPO Follow-up Study

Hypertension Clinical Trial

Official title:

The Effect of in Utero Hyperglycaemia, Maternal Overnutrition and Interaction With Postnatal Lifestyle on Cardiometabolic Risk at Young Adulthood - Extension of HAPO Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477511
• Other study ID #: HAPO-005
• Status: Recruiting
• Start date: August 28, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: Chi Chiu Wang
• Phone: +852 35052804
• Email: ccwang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Hong Kong, China

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

See protocol

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At a time around 18 years of age