Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
|Growth Hormone Deficiency||Other: GHRH+Arg, GHRH+Arg, ITT Other: ITT, ITT, GHRH+Arg.||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)|
- 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) ]
|Study Start Date:||January 2004|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
|Active Comparator: Group 1:||
Other: GHRH+Arg, GHRH+Arg, ITT
GHRH+Arg repeatability test (2 tests) + comparison with one IT test
|Active Comparator: Group 2:||
Other: ITT, ITT, GHRH+Arg.
IT repeatability test (2 tests) + comparison with one GHRH+Arg test
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060488
|CHU Bicêtre, Endocrinology and Reproductive Diseases Department|
|Le Kremlin Bicêtre, France|
|Principal Investigator:||Philippe Chanson, MD, Professor||CHU Bicêtre, Endocrinology and Reproductive Diseases Department|