Prevent CardioKids

Cardiovascular Disease Clinical Trial

Official title:

Prevent CardioKids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02113644
• Other study ID #: Prevent CardioKids
• Status: Recruiting
• Start date: April 2014
• Est. completion date: April 2029

Study information

• Verified date: April 2020
• Source: Maastricht University Medical Center
• Contact: A. Vreugdenhil, Dr.
• Phone: 003143-3875284
• Email: a.vreugdenhil[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Lifestyle intervention

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 year
Secondary	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	1 year
Secondary	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	1 year

External Links

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