1) To examine the effect of a 12-week multidisciplinary treatment on endothelial function, intima-media thickness and blood cholesterol in obese children (8-17 years).2) Investigate the changes in vascular function in obese children (8-17 years).
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endothelial function of the brachial and superficial femoral artery
Intima-media thickness of the carotid and superficial femoral artery
Secondary outcome
Body fat percentage, weight, blood cholesterol (and high-density lipoproteins,
low-density lipoproteins and triglycerides)
Background summary
The past two decades, the prevalence of obesity in children in USA, but also in
The Netherlands, has doubled. This increase in prevalence of obesity in
children emphasizes the importance of primary prevention of obesity in
children. Moreover, childhood obesity is associated with several risk factors
for later heart disease, diabetes, other chronic diseases and osteoartrosis.
Several previous studies examined the effect of childhood obesity on the
vascular function. It is found that even obese children at the age of 8-10
demonstrate endothelial dysfunction (which is a precursor to atheroslcerotic
diseases and is present in subjects with cardiovascular disease and risk
factors). In addition, childhood obesity leads to structural changes in the
arterial wall (increased intima-media thickness), increased levels of
homosyteine and a hyperviscosity of the blood. These changes are associated
with an increased risk of cardiovascular disease.
Primary prevention may be the key to decreasing obesity and limiting its
societal impact. Physical inactivity and life style changes (food ingestion)
are the most important factors that should be altered when preventing
(childhood) obesity. Especially starting an intervention at a young age may be
beneficial since it has been proposed that encouraging the development of
physical activity habits in children helps establish patterns that continue
into their adulthood.
Study objective
1) To examine the effect of a 12-week multidisciplinary treatment on
endothelial function, intima-media thickness and blood cholesterol in obese
children (8-17 years).
2) Investigate the changes in vascular function in obese children (8-17 years).
Study design
Observational pilotstudy in which a 12-week multidisciplinary treatment is
applied as an intervention.
Study burden and risks
All participants start with a non-invasive and minimally challenging assessment
of the vascular characteristics. First, echo-Doppler measurements are used to
examine baseline blood flow, intima-media thickness, arterial lumen and
endothelial function of 3 major conduit arteries (carotid, brachial,
superficial femoral artery). These assessments are not harmful and no risks are
associated. Several years of experience is present at the department of
Physiology regarding these experiments. In the past, these tests were used to
examine a broad group of subjects (elderly, spinal cord injury, metabolic
syndrome, obesity in adolescents and middle-aged, endurance athletes). The only
possible burden for the participants is the collection of capillary blood
(optional test). However, this collection is without any risks.
Geert Grooteplein-noord 21
6525 EZ Nijmegen
Nederland
Geert Grooteplein-noord 21
6525 EZ Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Aged 8-17 years
Healthy
Obesity (based on the international guidelines for obesity in children, see figure 1 in appendix 1)
Signed informed consent
Exclusion criteria
Metabolic, muscular or neurologic disease
Specific syndroms in which obesity is an inclusion criterium (Prader-Willi syndrom)
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 | NL14335.091.06 |