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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
  Purpose

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 Intervention
Growth Hormone Deficiency
 Drug: Growth Hormone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Fayds Project: Adipocyte Function and Somtropin Deficiency

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: May 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Growth hormone
Patients with a condition
 Drug: Growth Hormone

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with GH deficiency

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351818

Locations
Spain
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
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01351818     History of Changes
Other Study ID Numbers: FER-SOM-2004-01
Study First Received: May 2, 2011
Last Updated: May 10, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on May 16, 2013