a) To investigate the differences in adipokines and inflammatory markers between obese and normal weight children; b) to study these differences over age, and c) to correlate adipokine/inflammatory marker profiles to clinical parameters for obesity…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) the difference in adipokine/inflammatory profiles between obese children and
normal weight controls. 2) the relation between adipokine/inflammatory profiles
and clinical parameters for obesity.
Secondary outcome
Not applicable
Background summary
Obesity is regarded as a state of low-grade inflammation, characterized by an
increase in inflammatory makers and changing levels of adipose tissue-specific
inflammatory mediators, called *adipokines*. These inflammatory changes have
been associated with the development of obesity-related complications like
insulin-resistance and CVD. The potential use of adipokine/inflammatory
profiles as risk markers for CVD became the focus of a new Wilhelmina
KinderZiekenhuis/UMC Utrecht research line.
As the first stage of this new Wilhelmina KinderZiekenhuis/UMC Utrecht research
line, we would like to study differences in adipokine/inflammatory markers of
obese children versus normal weight sex- and age matched controls. First, using
state-of-the art MIA technology, we would like to make adipokine/inflammatory
marker profiles of 70 obese* versus 70 normal weight (+ 0.5 SD-0.5 SD for
age) children aged 6-16 years. Second, as differences in adipokine/inflammatory
marker profiles between obese and normal weight children might vary with age,
we want to study these differences over age. Finally, we would like to
correlate adipokine/inflammatory marker profiles to clinical parameters for
obesity (e.g. waist/hip circumference, plasma lipids).
Study objective
a) To investigate the differences in adipokines and inflammatory markers
between obese and normal weight children; b) to study these differences over
age, and c) to correlate adipokine/inflammatory marker profiles to clinical
parameters for obesity (e.g. waist/hip circumference, plasma lipids).
Study design
Observational, case-control study
Study burden and risks
Obese children are routinely assessed for obesity-related conditions in the
obesity polyclinic of the Meander hospital (Amersfoort). In case of study
participation, their only burden consists of two additional 10 millilitre blood
samples for study laboratory measurements, drawn during a routine venapuncture.
Normal-weight sex- and age-matched controls will also be selected from the
pediatric outpatient department, and only included in the study when no
inflammatory condition is diagnosed, as this might interfere with the
adipokine/inflammatory marker profiles. In case of study participation, the
normal weight controls* burden consists of a more extensive physical
examination (waist+hip circumference, bio-electrical impedance measurement,
blood pressure, in addition to the routine physical examination) and two to
three additional 10 millilitre blood samples for study laboratory measurements,
drawn during a routine venapuncture.
Risks for the participating subjects are negligible.
Since we aim to study differences in adipokine/inflammatory marker profiles
between obese and normal weight children, this study can only be performed in
minors.
There is not direct benefit for participating subjects.
Lundlaan 6
3584EA
NL
Lundlaan 6
3584EA
NL
Listed location countries
Age
Inclusion criteria
Patientgroup:
6-16 years of age
BMI (>30 kg/m2 projected at the age of18 years), according to international standards, see also Hirasing RA, Fredriks AM, van BS, Verloove-Vanhorick SP, Wit JM. [Increased prevalence of overweight and obesity in Dutch children, and the detection of overweight and obesity using international criteria and new reference diagrams]. Ned Tijdschr Geneeskd 2001 July 7;145(27):1303-8.;Controls:
Sex and age matched to patient group
-0.5 SD Newly referred patients to the pediatric outpatient department, by general practitioners, for the reason of:
- Suspected allergy or asthma
- Analysis of complaints of fatigue/malaise
- Prediction of final height
- Habitual constipation (i.e. constipation not explained by a disease)
Exclusion criteria
Patientgroup:
- Intoxication (smoking, i.e. sigaret use, drug-use)
- Acute illness (fever)
- Mental retardation
- Allergy with positive RAST for food/inhalation allergy and (history of) Muller class I-II reaction (i.e. severe systemic allergy/anaphylaxis)
- Asthma (based on doctors* diagnosis: history of recurrent wheezing, obstructive
lung function tests with reversibility after administration of β2-sympathicomimetics,
use of asthma-medication)
Controls:
- Intoxication (smoking, drug-use)
- Acute illness (fever)
- Mental retardation
Exclusion criteria for involved referrals:
- Allergy with positive RAST for food/inhalation allergy and (history of) Muller class I-II reaction (i.e. severe systemic allergy/anaphylaxis)
- Asthma (based on doctors* diagnosis: history of recurrent wheezing, obstructive lung function tests with reversibility after administration of β2-sympathicomimetics, use of asthma-medication)
- Complaints of fatigue/malaise explained by M.Pfeiffer, inflammatory or infectious illness (e.g. inflammatory bowel disease, (viral) hepatitis, rheumatologic disease)
- Assessment of height when short or tall stature (height ± 1 SD of target height (TH), so height outside TH-range) or endocrine explanation for abnormal growth pattern (e.g. growth hormone deficiency)
The exclusion-criteria are formulated on the assumption that these might influence adipokine/inflammatory profiles.
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 | NL28898.041.09 |