To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate growth hormone deficiency (GHD) and non-GHD. To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency of side effects in the different tests (arginine, clonidine, protein). MedDRA version: 12.1 Level: LLT
Conditions
Interventions
Product Name: Gelatin
Product Code: 3
Pharmaceutical Form: Powder for oral solution
Product Name: Arginin
Product Code: 1
Pharmaceutical Form: Injection*
Trade Name: Clonidine HCl CF 0,150 mg, table
Sponsors
Top Institute Food and Nutrition
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening will be carried out by the pediatrist. 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 from growth more than -0,25 SDS/year Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children will be excluded if other reasons than those related to GH for growth retardation were present, e.g. tumors. Turners syndrome Having a food allergy (gelatin protein) Use of medications Instable weight Disorders as cancer, cardiovascular diseases, diabetics, anorexia nervosa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate between GHD and non-GHD.;Secondary Objective: To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency in side effects in the different tests (arginine, clonidine, protein).;Primary end point(s): correlation between the tests coefficient of variation within a test | — |
Countries
Netherlands
Outcome results
None listed