Metabolic SyndromeNCT02746887
Risk Factors Related to Metabolic Syndrome in School-aged Children Who Were Born Preterm
An observational study of Metabolic Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a follow-up cohort study of 8 years old children born preterm at Seoul National University Children's Hospital in Korea from 2008-2009. The children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome. Read more about this study
- Who is it for?
- Ages 8 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Preterm/term cohort
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Nov 2016
- 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 8 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. school aged children who were born preterm with a gestational age less than 32 weeks or a birth weight less than 1,500 g 2. school aged children who were born healthy term
Who may be able to join
- Very low birth weight infants and/or born less than 32 weeks of gestation age
- Healthy term infants for control group
- Parents and children accept of participation
Who cannot join
- Major congenital anomalies
- Neuromuscular disease
- Chromosomal anomalies
- Patients receiving growth hormone therapy
- Primary hypothyroidism
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seung Han Shin
Seoul, 110-744
Seung Han Shin, MD, +82-2072-7230, revival421@empas.com
Young Hwa Jung, MD
About this study
This is a follow-up cohort study of 8 years old children born preterm at Seoul National University Children's Hospital in Korea from 2008-2009.
The children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome.
The purpose of this study is to compare growth and risk factors of metabolic syndrome among children born preterm and children born healthy term at school age
- Conditions
- Metabolic Syndrome
- Being tested
- Preterm/term cohort
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm/term cohortOther
| Study group | Role | What they receive |
|---|---|---|
| Preterm cohort | Preterm infants with a gestational age less than 32 weeks or birth weight less than 1,500 g Receives: Other: Preterm/term cohort | |
| Term control cohort | Healthy term infants Receives: Other: Preterm/term cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with abnormal laboratory values and/or abnormal physical status
Measured: at 8 years corrected age
Secondary outcomes (2)
The number of participants with catch-up growth failure
Measured: at 8 years corrected age
The number of participants with hypertension
Measured: at 8 years corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Han Shin, Seoul National University Hospital
- Investigators
- Seung Han Y Shin, MD, Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746887
- Sponsor's protocol ID
- 1509-030-702
- Status last verified
- Apr 2016
- First submitted
- 9 Dec 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Related to Metabolic Syndrome in School-aged Children Who Were Born Preterm
- ClinicalTrials.gov ID
- NCT02746887
- Acronym / sponsor ID
- 1509-030-702
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- 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.
This is a follow-up cohort study of 8 years old children born preterm at Seoul National University Children's Hospital in Korea from 2008-2009.
The children will visit outpatient clinics for examinations regarding growth, obesity and other risk factors related to metabolic syndrome.
The purpose of this study is to compare growth and risk factors of metabolic syndrome among children born preterm and children born healthy term at school age
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm cohort | – | Other: Preterm/term cohortPreterm infants with a gestational age less than 32 weeks or birth weight less than 1,500 g |
| Term control cohort | – | Other: Preterm/term cohortHealthy term infants |
Who may qualify
- Ages
- 8 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. school aged children who were born preterm with a gestational age less than 32 weeks or a birth weight less than 1,500 g 2. school aged children who were born healthy term
Key inclusion criteria (3 listed)
- Very low birth weight infants and/or born less than 32 weeks of gestation age
- Healthy term infants for control group
- Parents and children accept of participation
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Neuromuscular disease
- Chromosomal anomalies
- Patients receiving growth hormone therapy
- Primary hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preterm/term cohort | Other | Preterm cohort, Term control cohort |
Primary outcome
number of participants with abnormal laboratory values and/or abnormal physical status
Time frame: at 8 years corrected age
2 secondary outcomes
The number of participants with catch-up growth failure
Time frame: at 8 years corrected age
The number of participants with hypertension
Time frame: at 8 years corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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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.
Seung Han Y Shin, MD principal investigator
Seoul National University Children's Hospital
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 Metabolic Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 5 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 21 Apr 2016. 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 South Korea. 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?
Contact Seung Han Shin, MD (+82-02-2072-7230, revival421@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with abnormal laboratory values and/or abnormal physical status (time frame: at 8 years corrected age). 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 21 Apr 2016.