The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are present in children of different weight categories and whether these are age dependent. Also differences * and relationships between * vascular…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Metabolism disorders NEC
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to examine the difference in micro- and
macrovasculature characteristics in children with different weight
classifications (lean; overweight; obese; extreme obese; morbid obese).
Secondary outcome
Secondary endpoints are differences in lipoprotein profiles, pro-inflammatory,
fundus photography and OGTT profiles between different age groups, between lean
and overweight/obese children and in relation with the measured micro- and
macrovasculature characteristics
Background summary
Children and adolescents with overweight and obesity are predisposed to
significant health problems. It is known that childhood obesity can adversely
affect almost every organ system, and if left untreated, the major impact of
childhood overweight is likely to be felt in the next generation of adults.
Study objective
The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular
function markers are 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 design
Longitudinal study
Study burden and risks
All exams take place during the standard care 24 hour hospitalization of the
COACH program, no extra visits are required. During this hospitalization all
participants receive blood sampling as standard care, for this study an extra
volume of 10 mL blood will be sampled. Participants have to collect urine and
faeces. Furthermore, participants will receive retinal imaging and a
peripheral arterial tonometry (PAT), both non-invasive investigations. All the
measurements required for this study are classified as very low risk and
non-time consuming for the participants.
With little inconvenience and miminimal risks the results of this study provide
information on characteristics of micro-and macrovasculature and
pro-inflammatory profile in overweight and obese children of different age
categories. Furthermore, comparisons can be made with children with a normal,
healthy weight. This knowledge can be used to improve the health of children
with overweight and obesity.
P.Debeyelaan 25
Maastricht 6229 HX
NL
P.Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Participation in the COACH program
- Aged between 6 and 18 years (at time of inclusion)
- Overweight or obesity according to International Obesity Task Force (IOTF) criteria;For control group
- Aged between 6 and 18 years
- Normal weight according to the International Obesity Task Force (IOTF) criteria
- Undergo surgery for elective reasons
Exclusion criteria
Retardation
Inflammatory disease: auto-immune diseases, inflammatory bowel
diseases, hepatitis, dermatitis, nephritis, pancreatitis, gastro-enteritis,
vasculitis, salpingitis, arthritis, osteomyelitis, myositis, ear-nose-throat
infections
Allergic disease: asthma, eczema, hay fever, food allergies
Oncologic disease
Cystic Fibrosis
Type 1 Diabetes Mellitus
Congenital metabolic disease
Undernutrition
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43949.068.13 |
| Other | Prevent CardioKids |