Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

September 12, 2005 updated by: University Hospital, Angers

Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Recruiting
        • UH of Angers
        • Contact:
        • Principal Investigator:
          • Rohmer Vincent, Professor
      • Brest, France
        • Not yet recruiting
        • UH of Brest
        • Contact:
        • Principal Investigator:
          • Sonnet Emmanuel, Doctor
      • Caen, France
        • Not yet recruiting
        • UH of Caen
        • Contact:
        • Principal Investigator:
          • Reznik Yves, Professor
      • Limoges, France
      • Rennes, France, 35000
      • Tours, France
        • Not yet recruiting
        • UH of Tours
        • Contact:
        • Principal Investigator:
          • Lecompte Pierre, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Novo Nordisk A/S

Investigators

  • Study Director: Rohmer Vincent, Professor, CHU of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-04-03
  • 2004/10 (CCPPRB)
  • 0673 (AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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