We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187993
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by:
University Hospital, Angers
  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: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187993


Locations
France
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 Caen Not yet recruiting
Caen, France
Contact: Reznik       reznyk-y@chu-caen.fr   
Principal Investigator: Reznik Yves, Professor         
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         
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         
Sponsors and Collaborators
University Hospital, Angers
Novo Nordisk A/S
Investigators
Study Director: Rohmer Vincent, Professor CHU of Angers
  More Information

ClinicalTrials.gov Identifier: NCT00187993     History of Changes
Other Study ID Numbers: CP-04-03
2004/10 (CCPPRB)
0673 (AFSSAPS)
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs