Adipocyte Function and Somtropin Deficiency

Growth Hormone Deficiency Clinical Trial

— FAYDS  

Official title:

The Fayds Project: Adipocyte Function and Somtropin Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351818
• Other study ID #: FER-SOM-2004-01
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: May 10, 2011
• Start date: May 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• Growth Hormone

Locations

Country	Name	City	State
Spain	Investigational site	Badajoz
Spain	Investigational site	Cáceres
Spain	Investigational site	Cádiz
Spain	Investigational site	Córdoba
Spain	Investigational site	Don Benito	Badajoz
Spain	Investigational site	Granada
Spain	Investigational site	Huelva
Spain	Investigational site	Jaen
Spain	Investigational site	Málaga
Spain	Investigational site	Murcia
Spain	Investigational site	Sevilla
Spain	Investigational site	Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring SAU

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion		1 year	No
Secondary	Height assessment (using Harpenden stadiometer)		1 year	No
Secondary	Weight assessment		1 year	No
Secondary	BMI assessment		1 year	No