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.
The randomisation was carried out before the first test was performed. In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her. The subject's allocation to a given randomisation arm was determined on the basis of a centralised randomisation (answering service), balanced per group of subjects with a minimisation on 2 criteria: age and BMI. This was a centralised randomisation using a Interactive Voice Response System (IVRS) which was balanced in each of the following 3 categories of subjects: * Category A = healthy volunteers, * Category B = subjects with a strong probability of deficit in GH, * Category C = subjects with a low probability of deficit in GH. In each of these 3 categories, the subjects underwent 3 tests whose sequences were determined by the following randomisation group: * Group 1: GHRH+Arg, GHRH+Arg, ITT or * Group 2: ITT, ITT, GHRH+Arg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
69
GHRH+Arg repeatability test (2 tests) + comparison with one IT test
IT repeatability test (2 tests) + comparison with one GHRH+Arg test
CHU Bicêtre, Endocrinology and Reproductive Diseases Department
Le Kremlin-Bicêtre, France
Level of GH peak (recorded following stimulation tests)
Time frame: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).
It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.
Time frame: After each test and before leaving the hospital (the day of the test)
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