The aim of the project is to study the relation between hyperinsulinemia and changes in autonomic tone in adolescents with obesity. We have chosen to perform a pilot study, because of lack of comparable studies in the literature.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters in this study will be LF (ms2), HF (ms2), LF/HF ratio, TP
(ms2) and SDNN (ms). These parameters give information about the state of the
central nervous system. BMI (kg/m2), cortisol (nmol/l), melatonin (pgram/ml),
glucose (mmol/L), insulin levels (pmol/L) and the duration of obesity (months)
will be considered as possible regressors.
Secondary outcome
Not applicable
Background summary
Obesity is a fast growing major health problem throughout the Western world, in
the adult as well as in the paediatric population. Since the roots of adult
obesity are likely established in childhood and adolescence, this young age
group deserves extra attention, in order to intervene in the process of obesity
development as early as possible. In recent literature there are indications
that there is an important role for the autonomic nervous system in the health
problems related to obesity.
Study objective
The aim of the project is to study the relation between hyperinsulinemia and
changes in autonomic tone in adolescents with obesity. We have chosen to
perform a pilot study, because of lack of comparable studies in the literature.
Study design
During an OGTT (part of the routine laboratory investigation in obese
adolescents), a continuous ambulatory measurement of their heart frequency will
be made using the VU Ambulatory monitoring system. Cortisol and melatonin will
be measured in saliva at 8 am, 4 pm and 11 pm on the day that an OGTT is
performed. Use of grow curves will able us to asses the duration of obesity.
Study burden and risks
Non-invasive techniques: Ambulatory measurement of heart frequency
Cortisol and melatonin saliva test
Benefit: None
Risk: None
De Boelelaan 1117
1081HV Amsterdam
Nederland
De Boelelaan 1117
1081HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Boys, Age 12-18 years, BMI>95th perc.
Exclusion criteria
Congenital or acquired heart disease, neurological disabilities, diabetes mellitus, medication that may influence the autonomic nervous system and/or insulin resistance or secretion.
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 | NL20586.029.07 |