Rationale: 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). This could
be of interest for endocrinologists prescribing GH in clinical practice because strict dosing
may become even more important. Next to that, scientific evidence for clinical practice is
wanted.
Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid
profile; secondary objectives: remainder) we investigate the effect 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.
Study population: At least 32 subjects, both childhood as adult onset GHD men and women,
receiving GH treatment for at least one year, with an age between 20 and 65 years.
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) (normal dose). 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) (low
dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose)
for at least 24 weeks.