Growth Hormone DeficiencyFAYDSNCT01351818
Adipocyte Function and Somtropin Deficiency
An observational study of Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 12 sites in Spain.
Trial summary
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth Hormone
- How many people
- 62 participants
- Where
- 12 sitesSpain
- Study dates
- May 2005to Mar 2008
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with GH deficiency
Who may be able to join
- Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
- Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
- Body Mass Index (BMI) within ±1 SD
Who cannot join
- Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
- Diabetes mellitus
- Intestinal inflammatory disease
- Celiac disease
- Uncontrolled hyperthyroidism
- AIDS
Show all 10Show fewer
- Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
- Chronic liver disease
- Eating disorders: anorexia, bulimia, etc
- Long-term treatment with anti-obesity drugs or drugs causing malabsorption
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Investigational site
Badajoz, Badajoz
Investigational site
Cáceres, Cáceres
Investigational site
Cadiz, Cádiz
Investigational site
Córdoba, Córdoba
Investigational site
Don Benito, Badajoz
Investigational site
Granada, Granada
Investigational site
Huelva, Huelva
Investigational site
Jaén, Jaen
Investigational site
Málaga, Málaga
Investigational site
Murcia, Murcia
Investigational site
Santa Cruz de Tenerife, Tenerife
Investigational site
Seville, Sevilla
About this study
Official title: The Fayds Project: Adipocyte Function and Somtropin Deficiency
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.
Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Growth Hormone
- 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
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone | Patients with a condition Receives: Drug: Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion
Measured: 1 year
Secondary outcomes (3)
Height assessment (using Harpenden stadiometer)
Measured: 1 year
Weight assessment
Measured: 1 year
BMI assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionMar 2008
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351818
- Sponsor's protocol ID
- FER-SOM-2004-01
- Acronym
- FAYDS
- Status last verified
- May 2011
- First submitted
- 2 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fayds Project: Adipocyte Function and Somtropin Deficiency
- ClinicalTrials.gov ID
- NCT01351818
- Acronym / sponsor ID
- FAYDS / FER-SOM-2004-01
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ferring SAU
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 May 2011 (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.
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.
Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth hormone | – | Drug: Growth HormonePatients with a condition |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with GH deficiency
Key inclusion criteria (3 listed)
- Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
- Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
- Body Mass Index (BMI) within ±1 SD
Key exclusion criteria (10 listed)
- Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
- Diabetes mellitus
- Intestinal inflammatory disease
- Celiac disease
- Uncontrolled hyperthyroidism
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 | Growth hormone |
Primary outcome
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion
Time frame: 1 year
3 secondary outcomes
Height assessment (using Harpenden stadiometer)
Time frame: 1 year
Weight assessment
Time frame: 1 year
BMI assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
12 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 Ferring Pharmaceuticals at 12 sites in Spain.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 11 May 2011.