Primary objective: To evaluate the insulin sensitivity measured with Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) in obese children and adolescents 3 years after diagnosis of insulin resistance.Secondary objectives:1. To evaluate the…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Primary endpoint is the HOMA-IR measured between 2-5 years after diagnosis of
insulin resistance.
Secondary outcome
Secondary endpoints are BMI, FPG, T2DM and quality of life between 2-5 years
after diagnosis of insulin resistance
Background summary
Overweight and obesity in children and adolescents are major health problems
all over the world. One of the most important sequels of obesity is the
development of type 2 diabetes mellitus (T2DM). Longitudinal studies in adults
have demonstrated that insulin resistance progresses to T2DM. Particularly in
children and adolescents; there is not much insight (duration, severity and
contributing factors) in the actual progression of insulin resistance, which is
expected to ultimately result in T2DM in most cases. Therefore further studies
are needed in obese children and adolescents with insulin resistance to
evaluate their status of the insulin sensitivity over the years.
Study objective
Primary objective:
To evaluate the insulin sensitivity measured with Homeostatic Model Assessment
of Insulin Resistance (HOMA-IR) in obese children and adolescents 3 years after
diagnosis of insulin resistance.
Secondary objectives:
1. To evaluate the following criteria in obese children and adolescents 3 years
after the diagnosis of insulin resistance:
- Change in Body Mass Index (BMI)
- Change in Fasting Plasma Glucose (FPG)
- Progression to the provisional diagnosis of T2DM.
2. To evaluate quality of life in obese children and adolescents 3 years after
a diagnosis of insulin resistance
Study design
This study is a cohort study in which data are gathered on the 3-year follow up
of obese children and adolescents with insulin resistance.
Study burden and risks
Burden and risks as a result of this follow-up study are relatively limited
because a 3-yearly follow up screening for T2DM in obese children >10 years can
be considered standard care [Addendum voor kinderen bij de CBO-richtlijn
*Diagnostiek en behandeling van obesitas bij volwassenen en kinderen]. After
invitation for follow-up, one fasting blood-sample for each child will be
collected according to the addendum.
In case the results of the screening necessitate to have further diagnostic or
treatment investigations, these will be performed according to standard care
(this will include an Oral Glucose Tolerance Test (OGTT)).
Besides this standard care screening, all participants are asked to fulfil 3
questionnaires about the demographic characteristics, quality of life and also
dietary intake (approximately 1 hour).
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent.
The need for informed consent is waived in case parents/caregivers and subjects during the visit to the outpatient clinic did not make an objection orally against the use of their clinical data. In the
latter case, routinely collected clinical and laboratory data will be used only.
Exclusion criteria
Oral objection of subject and/or parents/caregivers for use of clinical data.
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 | NL37741.100.11 |