Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosi… (NCT01060488) | Clinical Trial Compass
CompletedPhase 3
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
France69 participantsStarted 2004-01
Plain-language summary
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency (AGHD) and subjects who were probably free of AGHD.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Subjects aged over 18 years and under 60 years,
* Female or male,
* Subjects not treated by GH or having stopped the treatment more than 15 days ago,
* Effective contraception in women of childbearing age: hormonal contraception or use of female condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD),
* Signed informed consent,
* Subjects possessing social security cover.
* Subjects having at least one of the following criteria were considered as subjects with a high probability of presenting a GH deficit:
* Subjects with a tumour of the hypothalamo-hypophyseal region (hypophyseal adenomata, craniopharyngioma, meningioma, etc.) in whom the presence of a hypophyseal insufficiency in GH must be tested preoperatively or postoperatively, or
* Subjects presenting a secondary ante-hypophyseal insufficiency to an inflammatory, infectious, post-traumatic pathology or to a hypophyseal necrosis, whose hypophyseal functional condition has already been documented and for whom a revaluation of GH secretion is desired, or
* Subjects having undergone, as adults, an irradiation hypothalamo-hypophyseal region, or a suprasellar irradiation, in a clinical context of GH deficit, or
* Subjects with a known organic ante-hypophyseal insufficiency beginning in childhood and with at least 1 associated deficit excluding prolactin.
* Subjects having at least one of the following criteria were considered as subjects with a low probability …
What they're measuring
1
Level of GH peak (recorded following stimulation tests)
Timeframe: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).