• Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

  NCT00156143

  CompletedInterventionalPhase 3Updated Jul 30, 2007
• Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype

  NCT01616095

  CompletedObservationalUpdated Apr 17, 2018
• Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.

  NCT07333521

  RecruitingObservationalUpdated Jun 24, 2026
• Consequence of Lifetime Isolated Growth Hormone Deficiency

  NCT00149708

  CompletedInterventionalNot ApplicableUpdated Jun 15, 2010
• The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)

  NCT05979480

  Unknown statusObservationalUpdated Aug 7, 2023
• Growth Hormone and Glucose Metabolism

  NCT00929799

  CompletedInterventionalPhase 4Updated Jun 30, 2009

ClinicalTrials.gov ID

NCT00187993

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Unknown status

Study Type

Observational

Enrollment

30

Last Update Posted

Sep 16, 2005Estimated

Start Date

May 2005

Completion Date

Aug 2005

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.

• Growth Hormone Deficiency

• Growth hormone

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Defined Population

Time Perspective

Prospective

Lead Sponsor

University Hospital, AngersOTHER_GOV

Collaborators

Novo Nordisk A/SINDUSTRY

reznyk-y@chu-caen.fr