Prevent CardioKids

April 28, 2020 updated by: Maastricht University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: K. Karnebeek, Drs.
  • Phone Number: 003143-3874402

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202AZ
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
        • Contact:
          • K Karnebeek, Drs.
          • Phone Number: 003143-3874402
        • Principal Investigator:
          • A Vreugdenhil, Dr
        • Sub-Investigator:
          • J. Plat, Prof.dr.
        • Sub-Investigator:
          • R. Mensink, Prof.dr.
        • Sub-Investigator:
          • J Rijks, Drs
        • Sub-Investigator:
          • K Karnebeek, Drs.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • Type 1 diabetes mellitus
    • Congenital metabolic diseases
  • Malnourished children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in characteristics of the microcirculation as measured via fundus photography
Time Frame: 1 year
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
1 year
Differences in characteristics of microcirculation measured via lipoprotein profiles
Time Frame: 1 year
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
1 year
Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles
Time Frame: 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Anita Vreugdenhil, dr., Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2029

Study Completion (Anticipated)

April 1, 2029

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prevent CardioKids

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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