To obtain values for lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) and markers for insulin sensitivity (insulin, glucose, HbA1c) in 3- to 5-year-old children.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
metabool syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Values for: total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides,
insulin, glucose and HbA1c.
Secondary outcome
Not applicable.
Background summary
The prevalence of childhood obesity is still increasing, also in the
Netherlands. Obesity can result in dyslipidemia and insulin resistance which
increase the risk on cardiovascular disease and type 2 diabetes at a later age.
The combination of cardiovascular risk factors in persons with obesity is known
as metabolic syndrome. According to an international consensus, metabolic
syndrome cannot be diagnosed in children under the age of ten years. However,
cardiovascular risk factors have been identified in children aged 6-9 years. We
plan to measure these parameters for clinical reasons in a group of obese
children 3- to 5-year-old. To evaluate these results, "normal" values are
needed which are not available for this age group.
Study objective
To obtain values for lipid profile (total cholesterol, HDL-cholesterol,
LDL-cholesterol, triglycerides) and markers for insulin sensitivity (insulin,
glucose, HbA1c) in 3- to 5-year-old children.
Study design
Observational study. To obtain reliable results for lipid profile and markers
of insulin resistance, blood must be drawn after an overnight fast. Therefore,
children are needed who undergo a procedure under anesthesia. Since these are
children mostly having an adeno/tonsillectomy, we have chosen this group of
children.
Children living in the Northern Netherlands, aged 3 to 5 years with normal BMI
who are eligible for adeno/tonsillectomy, will be informed by the
ENT-specialist about the study while visiting the ENT outpatient clinic. These
children are generally in good health with the exception of recurrent ENT
infections. Further information about the study will be given by the
researcher. Written informed consent will be obtained from the parents or legal
caretakers. The adeno/tonsillectomy will take place under complete anesthesia,
an intravenous catheter will be inserted by the anesthesiologist during the
procedure. Blood will be drawn from the intravenous catheter to determine lipid
profile and markers for insulin sensitivity. Thereafter, blood samples will be
destroyed.
The study will be performed at the University Medical Center Groningen, from
the first of October 2012, to the first of April 2013.
Study burden and risks
Blood will be drawn from the intravenous catheter which is already in place.
Total amount of blood drawn will be approximately 2 ml. There are no risks or
burden for the patients associated with participation. The study can only be
done in this group of patients as this study specifically aims to obtain
reference values for lipid profile and markers for insulin sensitivity in this
age category.
A possible benefit for the study participants could be the early detection of
yet unknown disorders. When values are < -3 SD or > 3 SD, determination of the
variable will be repeated in a new blood sample.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Children, aged 3 to 5 years.
2. Normal weight, i.e. body mass index below the international cut-off points for overweight.
Age 3 years: BMI < 17.9 kg/m2 (boys) and BMI < 17.6 kg/m2 (girls).
Age 4 years: BMI < 17.6 kg/m2 (boys) and BMI < 17.3 kg/m2 (girls).
Age 5 years: BMI < 17.4 kg/m2 (boys) and BMI < 17.2 kg/m2 (girls).
3. No chronic disease.
4. Planned for adeno- and/or tonsillectomy.
Exclusion criteria
1. Children under the age of 3 years and children 6 years of age or older.
2. Overweight, i.e. body mass index above the international cut-off points for normal weight.
Age 3 years: BMI * 17.9 kg/m2 (boys) and BMI * 17.6 kg/m2 (girls).
Age 4 years: BMI * 17.6 kg/m2 (boys) and BMI * 17.3 kg/m2 (girls).
Age 5 years: BMI * 17.4 kg/m2 (boys) and BMI * 17.2 kg/m2 (girls).
3. Chronic disease, other than ENT-infections.
4. Familiar hypercholesterolemia diagnosed in one or both parents.
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 | NL41145.042.12 |