Adipocyte Function and Somtropin Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01351818
• Date of registration: 02/05/2011
• Prospective Registration: No
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Adipocyte Function and Somtropin Deficiency FAYDS
• Scientific title: The Fayds Project: Adipocyte Function and Somtropin Deficiency
• Date of first enrolment: May 2005
• Target sample size: 62
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01351818
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Growth Hormone

Primary Outcome(s)

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(s)

BMI assessment [Time Frame: 1 year]

Weight assessment [Time Frame: 1 year]

Height assessment (using Harpenden stadiometer) [Time Frame: 1 year]

Secondary ID(s)

FER-SOM-2004-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ferring SAU