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Completed

NCT Number: NCT01351818

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site, Badajoz, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

Primary outcomes

  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 outcomes

  1. Height assessment (using Harpenden stadiometer)

    Time frame: 1 year

  2. Weight assessment

    Time frame: 1 year

  3. BMI assessment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring SAU

Registry information

Official study title

The Fayds Project: Adipocyte Function and Somtropin Deficiency

Acronym: FAYDS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 11, 2011
Registry last updated
May 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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