Clinical trial NCT04313998: The Effect of Early-life Risk Factors on the Etiology of Diabetes in Children: a Birth Cohort
Official title: Prevalence of Diabetes in Children and Its Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 300
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with GDM were recruited during late pregnancy, and the children were followed up at birth, 42 days after birth, 3month, 6month, 12month, 18month and 24month.

Brief summary: In recent years, with the rising prevalence of obesity among children, the incidence of type 2 diabetes in children and adolescents has continued to be increased. Some studies have found that impaired glucose metabolism appeared in 10-20% obese children. A large multicenter study project for children and adolescents showed that the prevalence of type 2 diabetes among children in the United States increased by 30.5% between 2001 and 2009. In addition, diabetes in children and adolescents, especially type 2 diabetes, has become more and more "younger". Diabetes appears in adolescence, which indicates that the damage of diabetes may come earlier, and it also has a significant impact on life quality and long-term survival. In recent years, more and more studies have shown that many adverse factors in the perinatal period would increase the risk of offspring suffering from metabolic diseases such as obesity and diabetes. Early life environmental factors would change the transcription and expression of obesity and diabetes-related genes through epigenetic regulation without changing the nucleotide sequence of the gene, then affecting the function of the gene and leading to diseases. Compared with the control group, pre-pregnant obese mothers and gestational diabetes mothers had higher DNA methylation levels in placenta leptin, which led to differences in the expression of leptin of offspring. A recent meta-analysis shows that the exposure to various social and environmental factors (diet, sleep, stress, bad habits, etc.) during pregnancy will affect the offspring. Due to the expression or methylation of CpG islands, these changes eventually lead to a variety of diseases including diabetes of offspring. However, most of previous researches mainly focused on the genetics or environmental factors. Meanwhile, most of the research focused on the Caucasian population. The differences between Asians and Westerners were few reported.

Detailed description: Study Design: Prospective observational cohort study. Aim: To explore the effect of maternal sleep during pregnancy on offspring's growth and metabolism and the potential epigenetic mechanism.

Participants: Pregnant women with Gestational Diabetes Mellitus(GDM) and their children.

Study Procedure: Pregnant women with GDM were recruited during late pregnancy, and the children were followed up at birth, 42 days after birth, 3month, 6month, 12month, 18month and 24month. Demographic information, physical examination, developmental and psychiatric assessment, diet, and physical activity, as well as biological samples were collected for further study.

Collaborators on this study include: Renji hospital, affiliated shanghai jiaotong university school of medicine

Eligibility criteria: Inclusion Criteria:

* Long-term resident in Shanghai, and no relocation plan for 2 years
* Ultrasonography indicated singleton pregnancy at 34-36 weeks
* Willing to participate and be able to follow-up at the specified time
* Diagnosed with gestational diabetes mellitus

Exclusion Criteria:

* Preterm labor symptoms during pregnancy;
* Diagnosed gestational hypertension ;
* Diagnosed heart disease, liver and kidney disease.
* Apgar score was 7 or below at 1 minute or 5 minutes with history of asphyxia at birth or were admitted to the neonatal intensive care unit after birth.

Primary outcomes:
measure: Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
timeFrame: changes from late pregnancy,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
measure: Maternal sleep measured by Actiwatch
timeFrame: baseline
measure: Children sleep measured by Actiwatch
timeFrame: changes from 3month,6month,12month ,18month and 24month follow-up
measure: Childrens' anthropometrics
timeFrame: Changes from birth，42days, 3month,6month,12month ,18month and 24month follow-up
measure: Cord blood DNA methylation
timeFrame: at birth
measure: maternal metabolism index
timeFrame: baseline
measure: infant metabolism index
timeFrame: baseline
measure: paternal metabolism index
timeFrame: baseline
measure: Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
timeFrame: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
measure: Early Child Development
timeFrame: changes from 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
state: Shanghai
Study officials:
References: