- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04313998
The Effect of Early-life Risk Factors on the Etiology of Diabetes in Children: a Birth Cohort
Prevalence of Diabetes in Children and Its Risk Factors
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 2000127
- Recruiting
- Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
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Contact:
- Fan Jiang, Ph.D
- Phone Number: 021-58750573
- Email: fanjiang@shsmu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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changes from late pregnancy,3 month, 6month, 9month, 12month, 18month, 24 month,36month,48month follow-up
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Maternal sleep measured by Actiwatch
Time Frame: baseline
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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.
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baseline
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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.
|
changes from 3month,6month,12month ,18month and 24month follow-up
|
Childrens' anthropometrics
Time Frame: Changes from birth,42days, 3month,6month,12month ,18month and 24month follow-up
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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.
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Changes from birth,42days, 3month,6month,12month ,18month and 24month follow-up
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Cord blood DNA methylation
Time Frame: at birth
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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).
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at birth
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maternal metabolism index
Time Frame: baseline
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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.
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baseline
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infant metabolism index
Time Frame: baseline
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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.
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baseline
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paternal metabolism index
Time Frame: baseline
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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.
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baseline
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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
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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.
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changes from birth, 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
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Early Child Development
Time Frame: changes from 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
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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.
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changes from 42days,3 month, 6month, 9month, 12month, 18month, 24 month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCMCIRB-K2017021
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