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Adipocyte Function and Somtropin Deficiency (FAYDS)

This study has been completed.
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01351818
First received: May 2, 2011
Last updated: May 10, 2011
Last verified: May 2011
History of Changes

May 2, 2011
May 10, 2011
May 2005
January 2008   (final data collection date for primary outcome measure)
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01351818 on ClinicalTrials.gov Archive Site
  • Height assessment (using Harpenden stadiometer) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Weight assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • BMI assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adipocyte Function and Somtropin Deficiency
The Fayds Project: Adipocyte Function and Somtropin Deficiency

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children with GH deficiency
Growth Hormone Deficiency
Drug: Growth Hormone
Growth hormone
Patients with a condition
Intervention: Drug: Growth Hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
March 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
5 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01351818
FER-SOM-2004-01
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring SAU
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP