Cardiovascular DiseaseNCT02113644
Prevent CardioKids
An observational study of Cardiovascular Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Lifestyle intervention
- How many people
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Overweight or obese children according to the International Obesity Task Force (IOTF) criteria between 6-18 years old. Overweight and obese children will be recruited in the COACH program. For the control group healthy, normal weight children between 6-18 years old.
Who may be able to join
- Participation in the COACH program
- Aged between 6 and 18 years (at time of inclusion)
- Overweight or obesity according to IOTF criteria
- In order to be eligible to participate in the control group, a subject must meet all of the following criteria:
- Aged between 6 and 18 years
- Normal weight according to the IOTF criteria
- Undergo surgery for elective reasons
Who cannot join
- Retarded children
- Children suffering from:
- Inflammatory diseases: auto-immune diseases, inflammatory bowel diseases, hepatitis, dermatitis, nephritis, pancreatitis, gastro-enteritis, vasculitis, salpingitis, arthritis, osteomyelitis, myositis, ear-nose-throat infections
- Allergic diseases: asthma, eczema, hay fever, food allergies
- Oncologic diseases
- Cystic fibrosis
Show all 9Show fewer
- Type 1 diabetes mellitus
- Congenital metabolic diseases
- Malnourished children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
K. Karnebeek, Drs. contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
A. Vreugdenhil, Dr., 0031433875284, a.vreugdenhil@mumc.nl
K Karnebeek, Drs., 003143-3874402
About this study
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.
Read the detailed description
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.The primary endpoint is to examine the difference in micro- and macro-vasculature characteristics in children with different weight classifications (lean; overweight; obese; extreme obese; morbid obese). Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory and oral glucose tolerance profiles between different age groups, between lean and overweight/obese children and in relation with the measured micro- and macro-vasculature characteristics
- Conditions
- Cardiovascular Disease
- Being tested
- Lifestyle intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Overweight or obese children | Overweight or obese children according to the International Obesity Task Force (IOTF) criteria following the lifestyle intervention in the Centre for Overweight Adolescent and Children's Healthcare Receives: Other: Lifestyle intervention | |
| Lean children | Lean children according to the International Obesity Task Force (IOTF) criteria admitted at de pediatric ward for a planned surgery, for example the correction of floppy ears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function measured by peripheral arterial tonometry (EndoPAT)
The primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups.
Measured: 1 year
Secondary outcomes (3)
Differences in characteristics of the microcirculation as measured via fundus photography
Differences in characteristics of the microcirculation as measured via fundus photography in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics
Measured: 1 year
Differences in characteristics of microcirculation measured via lipoprotein profiles
Differences in characteristics of the microcirculation as measured via lipoprotein profiles in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics
Measured: 1 year
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles in overweight/obese children in different age groups, between lean and overweight/obese children in different age groups and in relation with the measured micro- and macrovascular characteristics
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Vreugdenhil, dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113644
- Sponsor's protocol ID
- Prevent CardioKids
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2013
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent CardioKids
- ClinicalTrials.gov ID
- NCT02113644
- Acronym / sponsor ID
- Prevent CardioKids
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 14 Apr 2014 (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.
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.
Detailed description
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are already present in children of different weight categories and whether these are age dependent. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.The primary endpoint is to examine the difference in micro- and macro-vasculature characteristics in children with different weight classifications (lean; overweight; obese; extreme obese; morbid obese). Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory and oral glucose tolerance profiles between different age groups, between lean and overweight/obese children and in relation with the measured micro- and macro-vasculature characteristics
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight or obese children | – | Other: Lifestyle interventionOverweight or obese children according to the International Obesity Task Force (IOTF) criteria following the lifestyle intervention in the Centre for Overweight Adolescent and Children's Healthcare |
| Lean children | – | –Lean children according to the International Obesity Task Force (IOTF) criteria admitted at de pediatric ward for a planned surgery, for example the correction of floppy ears |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Overweight or obese children according to the International Obesity Task Force (IOTF) criteria between 6-18 years old. Overweight and obese children will be recruited in the COACH program. For the control group healthy, normal weight children between 6-18 years old.
Key inclusion criteria (7 listed)
- Participation in the COACH program
- Aged between 6 and 18 years (at time of inclusion)
- Overweight or obesity according to IOTF criteria
- In order to be eligible to participate in the control group, a subject must meet all of the following criteria:
- Aged between 6 and 18 years
Key exclusion criteria (9 listed)
- Retarded children
- Children suffering from:
- Malnourished children
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 |
|---|---|---|
| Lifestyle intervention | Other | Overweight or obese children |
Primary outcome
Vascular function measured by peripheral arterial tonometry (EndoPAT)
Time frame: 1 year
The primary endpoint is the difference in micro- and macrovascular characteristics, as measured by EndoPAT in lean/overweight/obese children in different age groups.
3 secondary outcomes
Differences in characteristics of the microcirculation as measured via fundus photography
Time frame: 1 year
Differences in characteristics of microcirculation measured via lipoprotein profiles
Time frame: 1 year
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Related InfoLink provided by the sponsor.
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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.
K. Karnebeek, Drs. contact
Anita Vreugdenhil, dr. principal investigator
Maastricht University Medical Center
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 Cardiovascular Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 9 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A. Vreugdenhil, Dr. (003143-3875284, a.vreugdenhil@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function measured by peripheral arterial tonometry (EndoPAT) (time frame: 1 year). 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 29 Apr 2020.