Infant, Small for Gestational AgeNCT00396474
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
An observational study of Infant, Small for Gestational Age, run by Pfizer.
Trial summary
The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant, Small for Gestational Age
- What is being tested?
- post GH treatment observational study
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: SGA Subjects treated or untreated with growth hormone
Who may be able to join
- Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years
- Untreated SGA (based on birth weight and/or length below -2 standard deviations [SDs] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:
- Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or
- Subjects born SGA with short stature (height SDs > 1.3 below target at final height).
Who cannot join
- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
- Familial dyslipidemia
About this study
Official title: Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls
The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.
Read the detailed description
case-control
- Conditions
- Infant, Small for Gestational Age
- Being tested
- post GH treatment observational study
- Keywords
- Small for gestational age, Insulin Sensitivity Index, growth hormone treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post GH treatment observational studyOther
Intravenous glucose tolerance test (IVGTT)
| Study group | Role | What they receive |
|---|---|---|
| SGA patients | Infants born small for SGA who either received GH, no GH, or growth within normal ranges. Receives: Other: post GH treatment observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height
Measured: 90 days
Secondary outcomes (2)
To demonstrate that blood pressure and lipid profile are not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH
Measured: 90 days
To demonstrate that the ISI is not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH that achieved normal final height
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startJan 2009
- Study completionJan 2012 (estimated)
Why it stopped: Study design no longer relevant and no patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Small for Gestational AgeStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396474
- Sponsor's protocol ID
- A6281279
- Status last verified
- Apr 2015
- First submitted
- 6 Nov 2006
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls
- ClinicalTrials.gov ID
- NCT00396474
- Acronym / sponsor ID
- A6281279
- Conditions
- Infant, Small for Gestational Age
- Keywords
- Small for gestational age, Insulin Sensitivity Index, growth hormone treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study design no longer relevant and no patients were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Jan 2012 (estimated)
- First posted
- 7 Nov 2006 (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.
The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.
Detailed description
case-control
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGA patients | – | Other: post GH treatment observational studyInfants born small for SGA who either received GH, no GH, or growth within normal ranges. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SGA Subjects treated or untreated with growth hormone
Key inclusion criteria (4 listed)
- Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years
- Untreated SGA (based on birth weight and/or length below -2 standard deviations [SDs] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:
Key exclusion criteria (2 listed)
- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
- Familial dyslipidemia
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 |
|---|---|---|
| post GH treatment observational studyIntravenous glucose tolerance test (IVGTT) | Other | SGA patients |
Primary outcome
To demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height
Time frame: 90 days
2 secondary outcomes
To demonstrate that blood pressure and lipid profile are not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH
Time frame: 90 days
To demonstrate that the ISI is not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH that achieved normal final height
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Small for Gestational Age, run by Pfizer.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height (time frame: 90 days). 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 22 Apr 2015.