Goal of this study is to investigate whether hepatic steatosis can be found in adolescents born SGA who have had prolonged GH treatment because of short stature. A possible relationship between hepatic steatosis and insulin sensitivity, adipose…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is hepatic fat content measured by MRS and echography.
Secondary outcome
Secundary outcome is the relationship between hepatic fat content and:
• time and total dose of the growth hormone treatment
• insulin sensitivity
• adipose tissue distribution
Background summary
Since 2005, children born small for gestational age (SGA) and without catch-up
growth, can be treated with growth hormone (GH) from the age of 4 years. The
positive effect on adult height of prolonged GH treatment has been well
documented. However, possible long-term side effects of GH treatment remain
unknown, especially on the risk of developing type 2 diabetes mellitus. A
prospective cohort study showed 20% less insulin sensitivity in 30% of
untreated adults born SGA, compared to adults born average for gestational age
(AGA). In 2.3% of these adults born SGA, "metabolic syndrome" could be
diagnosed, in contrast to 0.3% in adults born AGA. Short, untreated prepubertal
children born SGA, have reduced insulin sensitivity compared to short children
born AGA. In short children born SGA and treated with GH, this insulin
sensitivity is further reduced. Insulin sensitivity in short children born SGA,
6.5 years after cessation of the GH treatment, is equal to the insulin
sensitivity in untreated children born SGA. However, young adults born SGA
remain less insulin sensitive compared to adults born AGA. An increase in
hepatic fat could play a role in insulin resistance, for the liver has a
pivotal role in the interaction between lipid and carbohydrate metabolism in
the adipose tissue and muscle. Insulin resistance and visceral adipose tissue
are associated with hepatic steatosis. Hepatic steatosis can lead to
steatohepatitis and liver fibrosis.
Study objective
Goal of this study is to investigate whether hepatic steatosis can be found in
adolescents born SGA who have had prolonged GH treatment because of short
stature. A possible relationship between hepatic steatosis and insulin
sensitivity, adipose tissue distribution and lipid profile, will be studied.
Study design
Non-therapeutical cohort study.
Study burden and risks
Burden: standardised diet during 2 days prior to the oGTT, research visit on
single day which includes: anthropometry, insertion of intravenous catheter for
blood withdrawal, MRS and echography.
Risks: in case of failure of insertion of intravenous catheter, this has to be
repeated.
The study is group related and gives further information on possible long-term
side effects of growth hormone treatment in SGA born children. Furthermore,
this study may be beneficial for the study person as it could give relevant
medical information.
The study should be done in adolescents in the last fase of their growth
hormone treatment, i.e. at (near-)final height, to optimally investigate the
relationship between growth hormone treatment and hepatic steatosis. This means
that these adolescents might still be minors.
Postbus 30.001
9700 RB Groningen
NL
Postbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Group 1.
1. Adolescents, born SGA (birth weight or length less than -2 SDS for gestational age).
2. Growth hormone treatment because of short stature (no catch-up growth).
3. Near-final height (height velocity less than 1 cm during the last 6 months or less than 2 cm during the last year).
Group 2.
1. Adolescents born SGA, without catch-up growth.
2. No growth hormone treatment.
3. (Near-)final height less than -2 SDS.
Exclusion criteria
Disorders other than SGA influencing growth.
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 | NL27969.042.09 |