Study of new markers of adipocyte function (Leptin, Adiponectin and Resistita) and Ghrelin in children with GH deficiency. Evaluation of the effect of the exogenous administration of recombinant somatropin on these markers in children treated as usually in clinical practice.
DEC-NET Serial number ES493
Published online04/10/2005 10.46.00
Last updated27/10/2006 8.16.32
Other protocol ID numberFER-SOM-2004-01
Current trial statusOpen (actively recruiting new participants)
Major Disease
(ICD9 class)		DWARFISM NOT ELSEWHERE CLASSIFIED
Experimental drug
Somatropina
GenderBoth
Age (range)5-12 years old

Eligibility criteria
Exclusion criteria
Contraindication to recombinant somatropin treatment. Diabetes. Inflammatory bowel disease. Celiac disease. Uncontrolled hyperthyroidism and hypothyroidism. AIDS. Chronic hepatitis. Treatment with antiobesity drugs.

Trial design/methodology
Phase4
Kind of study
Design
Purpose of study
To assess the influence of the exogenous administration of growth hormone on the endocrine adipocyte function (Leptin, Adiponectin and Resistita) and on Ghrelin secretion in children with growth retardation related with GH deficiency treated with recombinant somatropin. To assess the endocrine adipocyte function and the plasmatic levels of Ghrelin in these children with GH deficiency, before substitutive treatment begins, and to compare these parameters with those in children without GH deficiency.
Primary outcomes
Leptine leptine receptor adiponectine resistite total Ghrelin active Ghrelin IGF-1 TNF-α IL-6
Secondary outcomes
Height weight BMI cephalic dominant arm, waist, abdomen and hip perimeter waist/hip index growing speed height gain.
Principal investigator
NameLuis Fernando López Canti
InstitutionHospital de Valme
Postal addressCarretera de Cádiz km 548,9
CitySevilla-41014
CountrySPAIN
Phone955-01 56 45
Fax
E-mail


Promoter
Ferring S.A. (Industry)

ISRCTN  EudraCT