Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00187993
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Novo Nordisk A/S
Information provided by:
University Hospital, Angers

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.

Condition or disease Intervention/treatment
Growth Hormone Deficiency Drug: Growth hormone

Study Type : Observational
Enrollment : 30 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.
Study Start Date : May 2005
Study Completion Date : August 2005

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00187993

UH of Angers Recruiting
Angers, France, 49000
Contact: Rohmer Vincent, Professor   
Principal Investigator: Rohmer Vincent, Professor         
UH of Brest Not yet recruiting
Brest, France
Contact: Sonnet Emmanuel, Dr   
Principal Investigator: Sonnet Emmanuel, Doctor         
UH of Caen Not yet recruiting
Caen, France
Contact: Reznik   
Principal Investigator: Reznik Yves, Professor         
UH of Limoges Not yet recruiting
Limoges, France
Contact: Tessier Marie-Pierre, Professor   
Principal Investigator: Tessier Marie-Pierre, Professor         
UH of Rennes Not yet recruiting
Rennes, France, 35000
Contact: Lorcy   
UH of Tours Not yet recruiting
Tours, France
Contact: Lecomte   
Principal Investigator: Lecompte Pierre, Professor         
Sponsors and Collaborators
University Hospital, Angers
Novo Nordisk A/S
Study Director: Rohmer Vincent, Professor CHU of Angers Identifier: NCT00187993     History of Changes
Other Study ID Numbers: CP-04-03
2004/10 (CCPPRB)
0673 (AFSSAPS)
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

Keywords provided by University Hospital, Angers:
growth hormone deficiency
growth hormone
energy expenditure
body composition

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