Prevent CardioKids

NCT02113644 | Recruiting

• 1 other identifier: Prevent CardioKids
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. Also differences - and relationships - between vascular function measurements and plasma biomarkers between lean and overweight/obese children will be compared.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Differences in characteristics of the microcirculation as measured via fundus photography

  1 year

• Differences in characteristics of microcirculation measured via lipoprotein profiles

  1 year

• Differences in characteristics of the microcirculation as measured via pro-inflammatory profiles

  1 year

Study Arms (2)

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

Interventions

Lifestyle intervention OTHER

Overweight or obese children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Participation in the COACH program
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Anita Vreugdenhil, dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. Vreugdenhil, Dr.

CONTACT

003143-3875284; a.vreugdenhil@mumc.nl

K. Karnebeek, Drs.

CONTACT

003143-3874402

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: April 14, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

NL (1)