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Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
This study is currently recruiting participants.
Verified by University Hospital, Angers, September 2005
First Received: September 12, 2005   No Changes Posted
Sponsors and Collaborators: University Hospital, Angers
Novo Nordisk
Information provided by: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00187993
  Purpose

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 Intervention
Growth Hormone Deficiency
Drug: Growth hormone

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187993

Locations
France
UH of Caen Not yet recruiting
Caen, France
Contact: Reznik         reznyk-y@chu-caen.fr    
Principal Investigator: Reznik Yves, Professor            
UH of Rennes Not yet recruiting
Rennes, France, 35000
Contact: Lorcy         yannick.lorcy@chu-rennes.fr    
UH of Tours Not yet recruiting
Tours, France
Contact: Lecomte         lecomte@med.univ-tours.fr    
Principal Investigator: Lecompte Pierre, Professor            
UH of Angers Recruiting
Angers, France, 49000
Contact: Rohmer Vincent, Professor         virohmer@chu-angers.fr    
Principal Investigator: Rohmer Vincent, Professor            
UH of Brest Not yet recruiting
Brest, France
Contact: Sonnet Emmanuel, Dr         emmanuel.sonnet@chu-brest.fr    
Principal Investigator: Sonnet Emmanuel, Doctor            
UH of Limoges Not yet recruiting
Limoges, France
Contact: Tessier Marie-Pierre, Professor         marie-pierre.tessier@chu-limoges.fr    
Principal Investigator: Tessier Marie-Pierre, Professor            
Sponsors and Collaborators
University Hospital, Angers
Novo Nordisk
Investigators
Study Director: Rohmer Vincent, Professor CHU of Angers
  More Information

No publications provided

Study ID Numbers: CP-04-03, 2004/10 (CCPPRB), 0673 (AFSSAPS)
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00187993     History of Changes
Health Authority: France : French Drug Agency

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

Study placed in the following topic categories:
Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Hypopituitary Dwarfism
Pituitary Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Growth Hormone Deficiency
Bone Diseases, Developmental
Endocrinopathy

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

ClinicalTrials.gov processed this record on July 06, 2009