Clinical trial NCT01351818: Adipocyte Function and Somtropin Deficiency
Official title: The Fayds Project: Adipocyte Function and Somtropin Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring SAU
First posted: 2011-05-11
Enrollment: 62
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with GH deficiency

Brief summary: To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.

Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.


Eligibility criteria: Inclusion Criteria:

* Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
* Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
* Body Mass Index (BMI) within ±1 SD

Exclusion Criteria:

* Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
* Diabetes mellitus
* Intestinal inflammatory disease
* Celiac disease
* Uncontrolled hyperthyroidism
* AIDS
* Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
* Chronic liver disease
* Eating disorders: anorexia, bulimia, etc
* Long-term treatment with anti-obesity drugs or drugs causing malabsorption

Primary outcomes:
measure: To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion
timeFrame: 1 year
Secondary outcomes:
measure: Height assessment (using Harpenden stadiometer)
timeFrame: 1 year
measure: Weight assessment
timeFrame: 1 year
measure: BMI assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Don Benito
country: Spain
facility: Investigational site
state: Badajoz
city: Badajoz
country: Spain
facility: Investigational site
city: Cáceres
country: Spain
facility: Investigational site
city: Cádiz
country: Spain
facility: Investigational site
city: Córdoba
country: Spain
facility: Investigational site
city: Granada
country: Spain
facility: Investigational site
city: Huelva
country: Spain
facility: Investigational site
city: Jaen
country: Spain
facility: Investigational site
city: Murcia
country: Spain
facility: Investigational site
city: Málaga
country: Spain
facility: Investigational site
city: Sevilla
country: Spain
facility: Investigational site
city: Tenerife
country: Spain
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: