Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect of GH treatment on glucose metabolism, physical performance, and neuropsychological functioning of…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in cardiovascular risk factors at baseline and after 24 weeks of
GH treatment with different target levels of IGF-I concentration.
Secondary outcome
Secundary we investigate the effect of GH treatment on glucose metabolism,
physical performance, and neuropsychological functioning at different levels of
IGF-I.
Background summary
Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both
associated with increased metabolic risk. Since (U-shaped) associations of
IGF-I, within the normal range, have also been found with cardiovascular risk
factors and disease in the general population, it would be interesting to
investigate if this association can also be found in growth hormone deficient
(GHD) adults treated with Growth Hormone (GH).
Study objective
Next to cardiovascular risk factors (main objectives: body composition and
lipid profile; secondary objectives: remainder) we investigate the effect of GH
treatment on glucose metabolism, physical performance, and neuropsychological
functioning of different levels of IGF-I in GH treated GHD men and women.
Study design
Open-label randomized trial
Intervention
At entry subjects are already receiving GH treatment according to general
clinical practice, and are expected to demonstrate an IGF-I concentration of 0
* 1 SD score (SDS) (ND). The group of men and group of women will be randomized
to receive either a decrease of their regular dose of GH treatment (IGF-I
target level of -2 * -1 SDS) (LD), or an increase of their regular dose, (IGF-I
target level of 1 * 2 SDS) (HD) for at least 24 weeks.
Study burden and risks
Subjects have to visit the research facility two times, each 24 weeks apart.
Most of the investigational techniques used in the protocol are employed
routinely in the clinic. No invasive investigation will be conducted, accept
blood sampling, which will be realized by a skilled investigator. Because GH
treatment is already used by each participant for at least one year, and dosed
within the reference range, serious adverse events are not to be expected, but
will be monitored closely. Eventually, outcome of the study could help to
prevent over- or undertreatment of GHD adults with regard to the outcome
measures included in this study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Ongoing surveillance at our centre (VUmc, Amsterdam)
- GH treated (at least one year)
- Men and women with an age between 20 and 65 years, both childhood as adult onset GHD
- Stable substitution therapies for other pituitary hormone deficiencies
Exclusion criteria
- Subjects with a craniopharyngioma as cause of their GHD or pituitary deficiencies
- Contraindications for the use of Growth Hormone treatment
- (Receiving treatment for) malignant disease (in the past)
- Cardiovascular event less than one year prior to inclusion
- Participation in other studies
- Subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-005066-36-NL |
| CCMO | NL42315.029.12 |