Comparing the reliability of a dietary-protein test with conventional Growth Hormone Stimulation Tests.
ID
Source
Brief title
Condition
- Other condition
- Hypothalamus and pituitary gland disorders
Synonym
Health condition
groeistoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A difference in reliability in the diagnose of GH-deficiency with the GHST*s
and the protein test, using TBW-test.
TBW-test is the evaluation test in this study to compare the predicting power
of the diagnostic tests. TBW-test is used to evaluate GH-therapy after 6 weeks.
Secondary outcome
-
Background summary
Current GHST*s to predict GH-deficiency in children are seriously criticized,
because the costs, side-effects and the low reliability of the results to
predict GH-deficiency. So there is a need for a more potent and physiological
GHST.
Study objective
Comparing the reliability of a dietary-protein test with conventional Growth
Hormone Stimulation Tests.
Study design
The experiment will be carried out by the pediatrist in the academic hospital
of Maastricht, immediately after standard tests for diagnosis of GH deficiency.
This test include the measurement of GH responses to intravenous administration
of arginine. After the standard tests, an extra test will be carried out. In
this test subjects receive a protein drink, containing complete soy protein.
Soy protein is a dietary protein, containing relatively high levels of arginine
and has been shown in our preceding studies to stimulate GH release in adult
women more potent in comparison with a solution of arginine.
Test persons receive a drink after the first sample and GH will be measured
every 20 min for 5 h.
Intervention
All children undergo an arginine-growth hormone stimulation test and one other
test (L-dopa, sleeping or chondiline), because of suspected growth retardation
based on one of the anthropametric criteria (inclusion criteria). In this
experiment, one test is added, the protein-test. The product soyprotein, use in
this test, is produced by NIZO (Nederlands Instituut Zuivel Onderzoek) and is a
solution of food-grade soyprotein.
Study burden and risks
This study is a non-therapeutic groups related study, with children from 6-12
years old. This study could not conducted without the participation of subjects
belonging to this group, because GH-deficiency is always determine in this
age-group and to make a comparison between the current diagnostic test and an
additional one, the same patients are needed. In healthy adults, we showed a
bigger increase in GH-release after oral ingestion of soyprotein in comparison
with arginine. In this study, we*d like to compare both tests, with respect to
determining of GH-deficiency in children.
The study does not include any risks for the subjects, apart from the usual
risks of blood sampling as bruises and little swellings. There are absolutely
no other risks, because the same catheter is used in all experiments. The same
catheter that is implemented for blood sampling in these experiments , so no
extra catheter will be implemented.
There are no risks for the subjects in using the protein drink, as the protein
used are food-proof and present in our daily diet.
Universiteitssingel 50,
6200MD
Nederland
Universiteitssingel 50,
6200MD
Nederland
Listed location countries
Age
Inclusion criteria
Eligibility for GHST's is based on one or more of the anthropometric criteria characterizing GH deficient patients:
* Height less than -2,5 SDS
* Deviation from target height more than 1.3 SDS
* Deviation of growth more than -0.25 SDS.
Exclusion criteria
Children will be excluded if other reasons than those related to GH for growth retardation were present. Because it is known that girls with Turner syndrome show a growth response to GH therapy, they will be included in the tests.
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 | NL17353.000.07 |