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临床试验/NCT05477511
NCT05477511招募中不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Rate of DM in the young adult offspring

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Rate of DM in the young adult offspring

时间窗: At a time around 18 years of age

Study specimens would be collected to identify the rate of DM in young adult offspring.

次要结局

  • Rate of impaired glucose regulation, obesity and adiposity, hypertension and various insulin indices(At a time around 18 years of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronald Wang

Professor

Chinese University of Hong Kong

研究点 (1)

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The Extension of HAPO Follow-up Study | 临床试验