Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests

Phase 1

Conditions: 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: 12.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

Registration Number: EUCTR2010-018781-23-NL

Lead Sponsor: Top Institute Food and Nutrition

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>To investigate the frequency in side effects in the different tests (arginine, clonidine, protein).;Primary end point(s): correlation between the tests<br>coefficient of variation within a test

Secondary Outcome Measures