The Extension of HAPO Follow-up Study

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Chi Chiu Wang; Phone Number: +852 35052804; Email: ccwang@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, China
    • Hong Kong, Hong Kong, China, Hong Kong, Shatin
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Chi Chiu Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Hong Kong women and their 18 year-old offspring

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Chi Chiu Wang, Chinese University of Hong Kong

Publications and helpful links

General Publications

• See protocol

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Pregnancy; Hyperglycemia; Overnutrition; Maternal Obesity; Gestational Diabetes Mellitus; Young Adulthood
• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hyperglycemia; Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics; Obesity, Maternal; Overnutrition
• Other Study ID Numbers: HAPO-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No