Child DevelopmentNCT04313998
The Effect of Early-life Risk Factors on the Etiology of Diabetes in Children: a Birth Cohort
An observational study of Child Development, run by Sijia Gu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 2000127
Fan Jiang, Ph.D, 021-58750573, fanjiang@shsmu.edu.cn
About this study
Official title: Prevalence of Diabetes in Children and Its Risk Factors
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.
Read the 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
- Conditions
- Child Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
The PSQI total score represents the sum of component scores for subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medicine, and daytime dysfunction. A PSQI score >5 defined poor sleep quality. Higher scores implied lower sleep quality or more severe sleep disturbance.
Measured: changes from late pregnancy,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
Maternal sleep measured by Actiwatch
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (AMI) and sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Measured: baseline
Children sleep measured by Actiwatch
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted by using Actiwatch (AMI) and sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Measured: changes from 3month,6month,12month ,18month and 24month follow-up
Childrens' anthropometrics
Child weight and length/height as well as BMI (calculated by weight divided by the square of length/height) were obtained at each visit. Weight was measured using calibrated scales (Seca 335, Hamburg, Germany) and length was measured from the top of the head to the soles of feet using the same calibrated scale as weight. From 6 month，childrens' arm circumference, triceps and subscapular skinfold thicknesses were also measured.
Measured: Changes from birth，42days, 3month,6month,12month ,18month and 24month follow-up
Cord blood DNA methylation
Cord blood samples were collected from the umbilical vein immediately after delivery, then were stored at 4 ℃ for a maximumof 4 h. They were then centrifuged, aliquoted, and stored in liquid nitrogen (-80℃) until assayed. DNA methylation was measured on bisulfite-converted genomic DNA in the company using the Illumina Infinium Human Methylation EPIC BeadChip (850k).
Measured: at birth
maternal metabolism index
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
Measured: baseline
infant metabolism index
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
Measured: baseline
paternal metabolism index
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
Measured: baseline
Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
Infant sleep problems reported by the mother and according to Brief Infant Sleep Questionnaire (BISQ). It is not a scale. The variables of the questionnaire included 1) nocturnal sleep duration (between the hours of 7 pm and 7 am); 2) daytime sleep duration (between the hours of 7 am and 7 pm); 3) number of night wakenings; 4) duration of wakefulness during the night hours (10 pm to 6 am); 5) nocturnal sleep-onset time (the time when the child falls asleep for the night); 6) settling time (latency to falling asleep for the night); 7) method of falling asleep; 8) location of sleep; 9) preferred body position; 10) age of child; 11) gender of child; 12) birth order; and 13) role of the responder who completed the BISQ. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers.
Measured: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
Early Child Development
The Griffiths Mental Development Scales (GMDS) assess the development of a child from 0 to 8 years across six separate subscales: Locomotor (A), Personal-social (B), Language (C), Eye-hand co-ordination (D), Performance (E), and Practical Reasoning (F).And the higher socres means better condition.
Measured: changes from 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study startJun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sijia Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313998
- Sponsor's protocol ID
- SCMCIRB-K2017021
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Diabetes in Children and Its Risk Factors
- ClinicalTrials.gov ID
- NCT04313998
- Acronym / sponsor ID
- SCMCIRB-K2017021
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sijia GuUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI)
Time frame: changes from late pregnancy,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
The PSQI total score represents the sum of component scores for subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medicine, and daytime dysfunction. A PSQI score >5 defined poor sleep quality. Higher scores implied lower sleep quality or more severe sleep disturbance.
Maternal sleep measured by Actiwatch
Time frame: baseline
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted during the third trimester by using Actiwatch (AMI) and sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children sleep measured by Actiwatch
Time frame: changes from 3month,6month,12month ,18month and 24month follow-up
Sleep assessment was a major part of the study. A 7-day assessment of mothers' sleep quality was conducted by using Actiwatch (AMI) and sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Childrens' anthropometrics
Time frame: Changes from birth，42days, 3month,6month,12month ,18month and 24month follow-up
Child weight and length/height as well as BMI (calculated by weight divided by the square of length/height) were obtained at each visit. Weight was measured using calibrated scales (Seca 335, Hamburg, Germany) and length was measured from the top of the head to the soles of feet using the same calibrated scale as weight. From 6 month，childrens' arm circumference, triceps and subscapular skinfold thicknesses were also measured.
Cord blood DNA methylation
Time frame: at birth
Cord blood samples were collected from the umbilical vein immediately after delivery, then were stored at 4 ℃ for a maximumof 4 h. They were then centrifuged, aliquoted, and stored in liquid nitrogen (-80℃) until assayed. DNA methylation was measured on bisulfite-converted genomic DNA in the company using the Illumina Infinium Human Methylation EPIC BeadChip (850k).
maternal metabolism index
Time frame: baseline
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
infant metabolism index
Time frame: baseline
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
paternal metabolism index
Time frame: baseline
Leptin, Ghrelin, Adiponectin, Lipid profiles, Fasting glucose, Insulin-Like Growth Factor-1, Vitamin D, Ca, P, Fe, Ferritin, Transferrin were measured following a standard operating procedure.
Children sleep measured by Brief Infant Sleep Questionnaire(BISQ)
Time frame: changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
Infant sleep problems reported by the mother and according to Brief Infant Sleep Questionnaire (BISQ). It is not a scale. The variables of the questionnaire included 1) nocturnal sleep duration (between the hours of 7 pm and 7 am); 2) daytime sleep duration (between the hours of 7 am and 7 pm); 3) number of night wakenings; 4) duration of wakefulness during the night hours (10 pm to 6 am); 5) nocturnal sleep-onset time (the time when the child falls asleep for the night); 6) settling time (latency to falling asleep for the night); 7) method of falling asleep; 8) location of sleep; 9) preferred body position; 10) age of child; 11) gender of child; 12) birth order; and 13) role of the responder who completed the BISQ. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers.
Early Child Development
Time frame: changes from 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
The Griffiths Mental Development Scales (GMDS) assess the development of a child from 0 to 8 years across six separate subscales: Locomotor (A), Personal-social (B), Language (C), Eye-hand co-ordination (D), Performance (E), and Practical Reasoning (F).And the higher socres means better condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Sijia Gu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sleep measured by Pittsburgh Sleep Quality Index(PSQI) (time frame: changes from late pregnancy,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.