CClinicalTrials.gg
Status unknownNCT00187993Updated Sep 16, 2005

Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

An observational study in Growth Hormone Deficiency, sponsored by University Hospital, Angers. Status unknown at 6 sites in France. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2005-09-16.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Growth Hormone Deficiency

Keywords

  • growth hormone deficiency
  • growth hormone
  • energy expenditure
  • body composition
03

In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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
05

Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
30 participants

Interventions

  • DrugGrowth hormone
06

Study locations

1 of 6 sites recruiting
  • UH of Angers
    Angers, 49000, France
    • Rohmer Vincent, Professor · Contact · virohmer@chu-angers.fr
    • Rohmer Vincent, Professor · Principal investigator
    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
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00187993
Lead sponsor
University Hospital, Angers
Collaborators
Novo Nordisk A/S
First posted
Sep 16, 2005
Start date
May 2005
Completion
Aug 2005
Last update
Sep 16, 2005

Study contacts

Rohmer Vincent, Professor
study director · CHU of Angers
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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