Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

NCT00187993 | Unknown

• 3 other identifiers: CP-04-032004/10 (CCPPRB)0673 (AFSSAPS)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Growth Hormone Deficiency

Keywords

growth hormone deficiency; growth hormone; energy expenditure; body composition

Interventions

Growth hormone DRUG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Somatotropic insufficiency
• All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity
• Pathologies modifing bone metabolism
• Pregnancy/Feeding
• Refusal to consent

Sponsors & Collaborators

• University Hospital, Angers: lead
• Novo Nordisk A/S: collaborator

Study Sites (6)

UH of Angers

Angers, 49000, France

RECRUITING

UH of Brest

Brest, France

NOT YET RECRUITING

UH of Caen

Caen, France

NOT YET RECRUITING

UH of Limoges

Limoges, France

NOT YET RECRUITING

UH of Rennes

Rennes, 35000, France

NOT YET RECRUITING

UH of Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rohmer Vincent, Professor

  CHU of Angers

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 16, 2005

Record last verified: 2005-09

Locations

FR (6)