Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

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Brief Title

Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

Official Title

Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

Brief Summary

      Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the
      growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves
      a fat mass increase with regard to lean mass, an atherogenic lipidic profile and
      participating to osteopenia mechanism and decrease the life quality. All these dysfunctions
      are partially or totally corrected by the GH prescription with patient deficient since
      adulthood.

      However, for patients deficient since childhood, no study have demonstrated that GH treatment
      during childhood present these same benefit when they are treated during adulthood.

      Primary objective of this study is to examine that fat mass significantly decrease due to GH
      treatment in adulthood for patient GH deficient since childhood, treated by GH during
      childhood but stopped since the end of adolescence.

      We compare the body composition and others energetic metabolism parameters in two patient
      groups, one treated by GH during 18 months, and the other with no treatment. Body composition
      and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic
      balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly
      labelled water) and biologic parameters (lipidic profile, thyroid hormones).

      This study will evaluate if the GH treatment of young GH deficient adults since childhood can
      be a benefit for body composition, lipidic profile and bone density.
    



Study Type

Observational




Condition

Growth Hormone Deficiency

Intervention

Growth hormone


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

30

Start Date

May 2005

Completion Date

August 2005


Eligibility Criteria

        Inclusion Criteria:

          -  Adults (age > 18-35 years)

          -  Stable body mass +/- 5 kg in 3 months

          -  GH deficiency since childhood, treated by GH during childhood, having stopped GH
             treatment at the end of adolescence

          -  Want to receive again GH treatment or refusing new GH treatment

          -  GH deficiency confirmed at adulthood by GHRH-Arginine test

          -  Women receiving GH treatment must have a efficient contraceptive method

          -  Have given a writing informed consent

        Exclusion Criteria:

          -  Somatotropic insufficiency

          -  All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus
             and obesity

          -  Participating to another clinical trial during the three months befor inclusion

          -  Pathologies modifing bone metabolism

          -  Pregnancy/Feeding

          -  Refusal to consent
      

Gender

All

Ages

18 Years - 35 Years

Accepts Healthy Volunteers

No

Contacts

Rohmer Vincent, Professor, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00187993

Organization ID

CP-04-03

Secondary IDs

2004/10 (CCPPRB)


Study Sponsor

University Hospital, Angers

Collaborators

 Novo Nordisk A/S

Study Sponsor

Rohmer Vincent, Professor, Study Director, CHU of Angers


Verification Date

September 2005