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Adipocyte Function and Somtropin Deficiency (FAYDS)

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ClinicalTrials.gov Identifier: NCT01351818
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
Ferring SAU
Information provided by:
Ferring Pharmaceuticals

May 2, 2011
May 11, 2011
May 11, 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 ]
Same as current
No Changes Posted
  • Height assessment (using Harpenden stadiometer) [ Time Frame: 1 year ]
  • Weight assessment [ Time Frame: 1 year ]
  • BMI assessment [ Time Frame: 1 year ]
Same as current
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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 Model: Cohort
Time Perspective: Prospective
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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.
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
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring SAU
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011