Clinical trial NCT05477511: The Extension of HAPO Follow-up Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 900
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong women and their 18 year-old offspring

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.

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

Primary outcomes:
measure: Rate of DM in the young adult offspring
timeFrame: At a time around 18 years of age
Secondary outcomes:
measure: Rate of impaired glucose regulation, obesity and adiposity, hypertension and various insulin indices
timeFrame: At a time around 18 years of age
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Kong, China
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Chiu Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: See protocol