Growth Hormone DeficiencyNCT00187993
Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
An observational study of Growth Hormone Deficiency, run by University Hospital, Angers at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth hormone
- How many people
- 30 participants
- Where
- 6 sitesFrance
- Study dates
- May 2005to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
UH of Angers
Angers, 49000
Rohmer Vincent, Professor, virohmer@chu-angers.fr
Rohmer Vincent, Professor
- Not yet recruiting
UH of Brest
Brest
Sonnet Emmanuel, Dr, emmanuel.sonnet@chu-brest.fr
Sonnet Emmanuel, Doctor
- Not yet recruiting
UH of Caen
Caen
Reznik, reznyk-y@chu-caen.fr
Reznik Yves, Professor
- Not yet recruiting
UH of Limoges
Limoges
Tessier Marie-Pierre, Professor, marie-pierre.tessier@chu-limoges.fr
Tessier Marie-Pierre, Professor
- Not yet recruiting
UH of Rennes
Rennes, 35000
Lorcy, yannick.lorcy@chu-rennes.fr
- Not yet recruiting
UH of Tours
Tours
Lecomte, lecomte@med.univ-tours.fr
Lecompte Pierre, Professor
About this study
Official title: 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.
Read more
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
- Being tested
- Growth hormone
- Keywords
- growth hormone deficiency, growth hormone, energy expenditure, body composition
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Novo Nordisk A/S
- Investigators
- Rohmer Vincent, Professor, Study director, CHU of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187993
- Sponsor's protocol ID
- CP-04-03
- Other IDs
- 2004/10 (CCPPRB), 0673 (AFSSAPS)
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.
- ClinicalTrials.gov ID
- NCT00187993
- Acronym / sponsor ID
- CP-04-03
- Conditions
- Growth Hormone Deficiency
- Keywords
- growth hormone deficiency, growth hormone, energy expenditure, body composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2005
- Study completion
- Aug 2005
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohmer Vincent, Professor study director
CHU of Angers
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by University Hospital, Angers at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2005.