born small for
gestational age (SGA) have an
increased risk of short adult stature.
studies have shown that both children and adults
born SGA have reduced insulin sensitivity. Adults born SGA have an
risk of insulin resistance and type 2 diabetes.
hormone treatment improves both short and long-term
height gain. However
it has also been
shown to further reduce insulin sensitivity and the long term outcome
remains unclear with one study demonstrating recovery of insulin
once growth hormone therapy was completed and another not.
and after treatment
is therefore required.
doses of growth hormone doses for children born
SGA without catch-up growth vary from 35 to 67 µg/kg/day
evaluate in short
children born SGA:
growth hormone doses (low vs. high vs. IGF-1 titrated dose) on
short-term height velocity, final height and insulin sensitivity
biochemical and genetic predictors of growth response and effects on
insulin resistance following growth hormone therapy
effects and safety of childhood growth hormone therapy evaluated in
adulthood (5 and 10 years after attaining final height)
primary objective is to evaluate changes in insulin sensitivity and
secretion and incidence of impaired glucose tolerance in short children
born SGA. This will be assessed by annual oral glucose tolerance tests
(OGTT) alternating with intravenous glucose tolerance tests (IVGTT).
Insulin sensitivity will be assessed by HOMA and first phase insulin
secretion will be assessed during long term growth hormone treatment.
short children born
for gestational age (BW < -2 SD according to country specific
age at birth more than 28 weeks
at 4 years of age (Height SDS < -2.5 according to country
for parental height (HSDS > 1 SD below parental adjusted HSDS
(=mid parental height SDS)
4-8.99 years (girls) and 4-9.99 years (boys)
at start of treatment (largest testis volume < 4 ml, breast
records must be available for 6 months prior to inclusion into the study
velocity SDS < 0 during last 6 months (according to country
must be naïve to growth hormone therapy
or suspected allergy to growth hormone
participation in growth hormone trial
mental retardation as judged by the investigator
or active malignancy
intracranial hypertension (present or past)
retardation due to chronic diseases, syndromes (like FAS) and
chromosomal anomalies (except for Silver Russell syndrome).
problems likely to lead to significant non-compliance
approval has been given to invite NESGAS patients who have completed 3
years of growth hormone treatment within NESGAS to join the NESGAS
Extension. Patients who consent to take part in the NESGAS Extension
will continue to receive 35 µg/kg/day growth hormone until
they reach final height. The purpose of the extension is to evaluate
the long term safety of growth hormone treatment.
Professor David Dunger,
BSPED Clinical Trials Unit
Department of Paediatrics
Tel +44 (0)1223 762944
Tel +44 (0)1223 763405
Tracey Kirkwood (Research
Tel +44 (0) 121 333 8198
Sheena McGowan (Research
Tel +44 0141 201 0502
information is available from the BSPED