Adipocyte Function and Somtropin Deficiency (FAYDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351818
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
Ferring SAU
Information provided by:
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment
Growth Hormone Deficiency Drug: Growth Hormone

Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Fayds Project: Adipocyte Function and Somtropin Deficiency
Study Start Date : May 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Group/Cohort Intervention/treatment
Growth hormone
Patients with a condition
Drug: Growth Hormone

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Height assessment (using Harpenden stadiometer) [ Time Frame: 1 year ]
  2. Weight assessment [ Time Frame: 1 year ]
  3. BMI assessment [ Time Frame: 1 year ]

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with GH deficiency

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351818

Investigational site
Don Benito, Badajoz, Spain
Investigational site
Badajoz, Spain
Investigational site
Cáceres, Spain
Investigational site
Cádiz, Spain
Investigational site
Córdoba, Spain
Investigational site
Granada, Spain
Investigational site
Huelva, Spain
Investigational site
Jaen, Spain
Investigational site
Murcia, Spain
Investigational site
Málaga, Spain
Investigational site
Sevilla, Spain
Investigational site
Tenerife, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT01351818     History of Changes
Other Study ID Numbers: FER-SOM-2004-01
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs