Small for Gestational AgePhase 4SGANCT00597480
Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH)
A Phase 4 study testing rhGH (Norditropine SimpleXx®) and rhGH norditropine simple Xx in people with Small for Gestational Age, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Small for Gestational Age
- What is being tested?
- rhGH (Norditropine SimpleXx®) and rhGH norditropine simple Xx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 2012
- Phase
- Phase 4
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prepubertal age
- Prepubertal characteristics
- Non GH deficient
- Short children (height < -2.5 SDS)
- Born SGA (birth height < -2 SDS)
- Parental height adjusted (< -1 DS)
- No rhGH treatment before inclusion
Who cannot join
- ALLERY to rhGH or excipients
- Small height etiologies
- Cancer or cancer treatment ongoing
- Drugs interference with growth
- Mental impairment
- Hypertrophic cardiopathy impairment
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- Hypertension not under controlled
- Intra cranial hypertension not controlled
- Diabetes and hyperglycaemia without diabetes
- Dyslipidemia
- Hepatitis
- Kidney failure
- Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome)
- No social security
- State of health in worst conditions after cardiac surgery, polytraumatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Read the detailed description
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Because rhGH use in this population will sharply increase in the coming years, our purpose is to identify and analyze factors that predispose these children born SGA to the metabolic consequences of rhGH therapy.
The main objective of this study is to identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA. We want to:
- Quantify the metabolic effects of rhGH treatment by analyzing insulin levels, insulin sensitivity and lipid profile (lipolysis and ketogenesis);
- Evaluate the effects of two different rhGH regimens on the growth of children born SGA;
- Determine if the metabolic effects of rhGH therapy correlate to the growth responses in the two groups;
- Identify factors, especially genetic factors, responsible for the variations in individual metabolic and growth-promoting effects of rhGH in children born SGA.
This is a randomized, open-labeled, 2-year study, which will compare two regimens of rhGH therapy on the growth responses and metabolic effects in short children born SGA.
100 prepubertal, non GH deficient, short children (height < -3 SDS) born SGA (birth height < -2 SDS) will be randomized to receive either the recommended dose in the EU of rhGH (Norditropine SimpleXx®), or the dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day) for 24 months.
Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI), fasting insulin and glucose levels, HOMA index of insulin resistance, insulin and glucose levels during OGTT, HbA1C and fasting serum lipids (free fatty acids, 3-hydroxybutyrate, total cholesterol, LDL and HDL cholesterol, triglycerides). Height, growth velocity, IGF-1 and IGF-BP3 levels will evaluate growth response of rhGH treatment.
Polymorphisms of different genes of the signaling pathway of GH and insulin will be analyzed in order to search for those possibly responsible for the variability in metabolic and growth responses during rhGH treatment in SGA children.
- Conditions
- Small for Gestational Age
- Being tested
- rhGH (Norditropine SimpleXx®), rhGH norditropine simple Xx
- Keywords
- Growth hormone, Child, insulin resistance, metabolic syndrome X, children born small for gestational age
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGH (Norditropine SimpleXx®)Drug
the recommended dose in the EU of rhGH (Norditropine SimpleXx®
rhGH norditropine simple XxDrug
the dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | the recommended dose in the EU of rhGH (Norditropine SimpleXx®) Receives: Drug: rhGH (Norditropine SimpleXx®) |
| 2 | Active comparator | the dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day) Receives: Drug: rhGH norditropine simple Xx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA
Measured: every three months during twenty seven months
Secondary outcomes (2)
Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI)
Measured: every three months during
Polymorphisms of different genes of the signaling pathway of GH and insulin
Measured: the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: no more inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational AgeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Cecile Teinturier, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597480
- Sponsor's protocol ID
- P070303
- Acronym
- SGA
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2008
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH
- ClinicalTrials.gov ID
- NCT00597480
- Acronym / sponsor ID
- SGA / P070303
- Conditions
- Small for Gestational Age
- Keywords
- Growth hormone, Child, insulin resistance, metabolic syndrome X, children born small for gestational age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more inclusions
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Jan 2008 (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.
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Detailed description
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Because rhGH use in this population will sharply increase in the coming years, our purpose is to identify and analyze factors that predispose these children born SGA to the metabolic consequences of rhGH therapy.
The main objective of this study is to identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA. We want to:
- Quantify the metabolic effects of rhGH treatment by analyzing insulin levels, insulin sensitivity and lipid profile (lipolysis and ketogenesis);
- Evaluate the effects of two different rhGH regimens on the growth of children born SGA;
- Determine if the metabolic effects of rhGH therapy correlate to the growth responses in the two groups;
- Identify factors, especially genetic factors, responsible for the variations in individual metabolic and growth-promoting effects of rhGH in children born SGA.
This is a randomized, open-labeled, 2-year study, which will compare two regimens of rhGH therapy on the growth responses and metabolic effects in short children born SGA.
100 prepubertal, non GH deficient, short children (height < -3 SDS) born SGA (birth height < -2 SDS) will be randomized to receive either the recommended dose in the EU of rhGH (Norditropine SimpleXx®), or the dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day) for 24 months.
Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI), fasting insulin and glucose levels, HOMA index of insulin resistance, insulin and glucose levels during OGTT, HbA1C and fasting serum lipids (free fatty acids, 3-hydroxybutyrate, total cholesterol, LDL and HDL cholesterol, triglycerides). Height, growth velocity, IGF-1 and IGF-BP3 levels will evaluate growth response of rhGH treatment.
Polymorphisms of different genes of the signaling pathway of GH and insulin will be analyzed in order to search for those possibly responsible for the variability in metabolic and growth responses during rhGH treatment in SGA children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: rhGH (Norditropine SimpleXx®)the recommended dose in the EU of rhGH (Norditropine SimpleXx®) |
| 2 | Active comparator | Drug: rhGH norditropine simple Xxthe dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day) |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Prepubertal age
- Prepubertal characteristics
- Non GH deficient
- Short children (height < -2.5 SDS)
- Born SGA (birth height < -2 SDS)
Key exclusion criteria (15 listed)
- ALLERY to rhGH or excipients
- Small height etiologies
- Cancer or cancer treatment ongoing
- Drugs interference with growth
- Mental impairment
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 |
|---|---|---|
| rhGH (Norditropine SimpleXx®)the recommended dose in the EU of rhGH (Norditropine SimpleXx® | Drug | 1 |
| rhGH norditropine simple Xxthe dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day) | Drug | 2 |
Primary outcome
Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA
Time frame: every three months during twenty seven months
2 secondary outcomes
Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI)
Time frame: every three months during
Polymorphisms of different genes of the signaling pathway of GH and insulin
Time frame: the day of inclusion
Results and safety
The study was stopped early (reason given: no more inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Cecile Teinturier, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhGH (Norditropine SimpleXx®) and rhGH norditropine simple Xx in people with Small for Gestational Age, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 15 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: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no more inclusions). Results are not available in the source record.
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?
Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA (time frame: every three months during twenty seven months). 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 3 Apr 2026.