Adipocyte Function and Somtropin Deficiency

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Growth hormone deficiency
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Brief Title

Adipocyte Function and Somtropin Deficiency

Official Title

The Fayds Project: Adipocyte Function and Somtropin Deficiency

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.

Study Type

Observational

Primary Outcome

To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion

Secondary Outcome

 Height assessment (using Harpenden stadiometer)

Condition

Growth Hormone Deficiency

Intervention

Growth Hormone

Study Arms / Comparison Groups

 Growth hormone
Description:  Patients with a condition

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

62

Start Date

May 2005

Completion Date

March 2008

Primary Completion Date

January 2008

Eligibility 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

Gender

All

Ages

5 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Clinical Development Support, ,

Location Countries

Spain

Location Countries

Spain

Administrative Informations

NCT ID

NCT01351818

Organization ID

FER-SOM-2004-01

Study Sponsor

Ferring Pharmaceuticals

Collaborators

 Ferring SAU

Study Sponsor

Clinical Development Support, Study Director, Ferring Pharmaceuticals

Verification Date

May 2011