Metabolic SyndromeNCT02518854
Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome
An observational study of Metabolic Syndrome and Cardiovascular Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Cardiovascular Disease
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to 31 Mar 2017
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged 6-18 years visit pediatric nephrology clinic during study period
Who may be able to join
- children with ≧ one of the following criteria of metabolic syndrome
- weist circumstance ≧90th percentile
- TG≧150 mg/dL
- HDL<40 mg/dL
- BP>≧90th percentile
- A.C. glucose>100 mg/dL or T2D
- Volunteer
Who cannot join
- inability to complete study procedures
- pregnancy
- malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world.
Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals:
- To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.
Read the detailed description
Metabolic syndrome (MetS) is highly prevalent all over the world, including Taiwan. So far, there is still no standard definition of MetS for use in pediatric population. Thus MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world.
MetS might originate from early life, namely developmental programming. Cardiovascular disease (CVD) is the most common comorbidity of MetS. Therefore identification of biomarkers for detecting children with high-risk to develop CVD and MetS progression is our priority. Investigators' previous studies identified some biomarkers from a variety of programming models, including asymmetric dimethylarginine (ADMA, a nitric oxide synthase inhibitor), β-trace protein (BTP, also known as lipocalin-type prostaglandin D synthase), and adiponectin. Thus, in the current study, ADMA profile, BTP, and adiponectin will be studied in children and adolescents with pre-MetS to explore their role as biomarkers to predict MetS and CVD progression.
In childhood, assessment of CVD relies on endothelial function and arterial stiffness, as CV events are extremely rare. Thus, in this study investigators intend to perform a global vascular assessment (to determine endothelial function and arterial stiffness) in children with pre-MetS including 24hr ABPM, measure of pulse wave velocity (PWV) and ambulatory arterial stiffness index (AASI) to detect arterial stiffness, detection of flow mediated dilatation (FMD), and biomarkers. Investigators also intend to examine the correlation between biomarkers and these measured vascular parameters in children with preMetS.
Therefore, investigators will recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals:
- To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.
- Conditions
- Metabolic Syndrome, Cardiovascular Disease
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study | children aged 6-18 years with pre-metabolic syndrome | |
| control | children aged 6-18 years without pre-metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetric dimethylarginine (ADMA)
Differences of ADMA level (μM) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
Secondary outcomes (5)
Adiponectin
Differences of adiponectin level (μg/mL) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
β-trace protein (BTP)
Differences of BTP level (mg/dL) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
Flow-mediated dilation (FMD)
Differences of FMD (%) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
Pulse wave velocity (PWV)
Differences of PWV (m/s) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
Ambulatory arterial stiffness index (AASI)
Differences of AASI (unit) in children with pre-Metabolic syndrome vs. control.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJun 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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 Chang Gung Memorial 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tain, You-Lin, Chang Gung Memorial Hospital
- Investigators
- You-Lin Tain, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518854
- Sponsor's protocol ID
- 104-1970A3
- Status last verified
- Jul 2017
- First submitted
- 4 Aug 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers and Cardiovascular Risk Factors in Childhood Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02518854
- Acronym / sponsor ID
- 104-1970A3
- Conditions
- Metabolic Syndrome, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 10 Aug 2015 (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.
Metabolic syndrome (MetS) is highly prevalent all over the world. MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world.
Investigators intend to recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals:
- To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.
Detailed description
Metabolic syndrome (MetS) is highly prevalent all over the world, including Taiwan. So far, there is still no standard definition of MetS for use in pediatric population. Thus MetS is largely under-diagnosed in children and adolescents. Obesity and hypertension are two important requirements for criteria of MetS. With early detection and early intervention of MetS in children and adolescents will enable better care to reduce the heavy burden of health care all over the world.
MetS might originate from early life, namely developmental programming. Cardiovascular disease (CVD) is the most common comorbidity of MetS. Therefore identification of biomarkers for detecting children with high-risk to develop CVD and MetS progression is our priority. Investigators' previous studies identified some biomarkers from a variety of programming models, including asymmetric dimethylarginine (ADMA, a nitric oxide synthase inhibitor), β-trace protein (BTP, also known as lipocalin-type prostaglandin D synthase), and adiponectin. Thus, in the current study, ADMA profile, BTP, and adiponectin will be studied in children and adolescents with pre-MetS to explore their role as biomarkers to predict MetS and CVD progression.
In childhood, assessment of CVD relies on endothelial function and arterial stiffness, as CV events are extremely rare. Thus, in this study investigators intend to perform a global vascular assessment (to determine endothelial function and arterial stiffness) in children with pre-MetS including 24hr ABPM, measure of pulse wave velocity (PWV) and ambulatory arterial stiffness index (AASI) to detect arterial stiffness, detection of flow mediated dilatation (FMD), and biomarkers. Investigators also intend to examine the correlation between biomarkers and these measured vascular parameters in children with preMetS.
Therefore, investigators will recruit 150 children and adolescents age 6 to 18 yr with overweight/obesity or prehypertension/hypertension and 50 normal age-matched controls to reach the following research goals:
- To identify biomarkers as risk factors; 2) To characterize that impact of vascular assessment in preMetS children; and 3) To examine the relationship among biomarkers, vascular assessment parameters, and metabolic phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | –children aged 6-18 years with pre-metabolic syndrome |
| control | – | –children aged 6-18 years without pre-metabolic syndrome |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged 6-18 years visit pediatric nephrology clinic during study period
Key inclusion criteria (7 listed)
- children with ≧ one of the following criteria of metabolic syndrome
- Volunteer
Key exclusion criteria (3 listed)
- inability to complete study procedures
- pregnancy
- malignancy.
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
Asymmetric dimethylarginine (ADMA)
Time frame: At the time of enrollment
Differences of ADMA level (μM) in children with pre-Metabolic syndrome vs. control.
5 secondary outcomes
Adiponectin
Time frame: At the time of enrollment
β-trace protein (BTP)
Time frame: At the time of enrollment
Flow-mediated dilation (FMD)
Time frame: At the time of enrollment
Pulse wave velocity (PWV)
Time frame: At the time of enrollment
Ambulatory arterial stiffness index (AASI)
Time frame: At the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
You-Lin Tain, MD, PhD principal investigator
Chang Gung Memorial 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 and Cardiovascular Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jul 2017. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetric dimethylarginine (ADMA) (time frame: At the time of enrollment). 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 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.