Foetal Growth ProblemNCT00787878
Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
An observational study of Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin and No treatment given
- How many people
- 153 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Jan 2011
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Study population: GH treated SGA and controls of non-treated SGA and AGA
Who may be able to join
- Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials
- Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age
- Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age
Who cannot join
- Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l
- Insulin like growth (IGF)-1 level less than -2 SDS
- Receipt of any investigational drug within four weeks prior to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects
The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Being tested
- somatropin, No treatment given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Also called GHLIQUID
SGA previously treated with Norditropin®
No treatment givenDrug
Untreated SGA
No treatment givenDrug
AGA (Average gestational age)
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: somatropin | |
| B | Not described Receives: Drug: No treatment given | |
| C | Not described Receives: Drug: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: Index 5 years after end of GH treatment compared to controls
Secondary outcomes (1)
Disposition index, glucose effectiveness and acute insulin response compared to controls
Measured: 5 years after end of Norditropin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foetal Growth ProblemStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Cohort
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787878
- Sponsor's protocol ID
- GHLIQUID-1975
- Status last verified
- Jan 2017
- First submitted
- 7 Nov 2008
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
van Dijk M, Bannink EM, van Pareren YK, Mulder PG, Hokken-Koelega AC. Risk factors for diabetes mellitus type 2 and metabolic syndrome are comparable for previously growth hormone-treated young adults born small for gestational age (sga) and untreated short SGA controls. J Clin Endocrinol Metab. 2007 Jan;92(1):160-5. doi: 10.1210/jc.2006-1073. Epub 2006 Oct 24.
PubMed 17062774
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects
- ClinicalTrials.gov ID
- NCT00787878
- Acronym / sponsor ID
- GHLIQUID-1975
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Nov 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.
The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: somatropin |
| B | – | Drug: No treatment given |
| C | – | Drug: No treatment given |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- GH treated SGA and controls of non-treated SGA and AGA
Key inclusion criteria (3 listed)
- Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials
- Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age
- Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age
Key exclusion criteria (3 listed)
- Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l
- Insulin like growth (IGF)-1 level less than -2 SDS
- Receipt of any investigational drug within four weeks prior to the trial
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 |
|---|---|---|
| somatropinAlso: GHLIQUIDSGA previously treated with Norditropin® | Drug | A |
| No treatment givenUntreated SGA | Drug | B |
| No treatment givenAGA (Average gestational age) | Drug | C |
Primary outcome
Insulin sensitivity
Time frame: Index 5 years after end of GH treatment compared to controls
1 secondary outcome
Disposition index, glucose effectiveness and acute insulin response compared to controls
Time frame: 5 years after end of Norditropin treatment
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 18 Jan 2017.
- Results publication: PubMed 17062774van Dijk M, Bannink EM, van Pareren YK, Mulder PG, Hokken-Koelega AC. Risk factors for diabetes mellitus type 2 and metabolic syndrome are comparable for previously growth hormone-treated young adults born small for gestational age (sga) and untreated short SGA controls. J Clin Endocrinol Metab. 2007 Jan;92(1):160-5. doi: 10.1210/jc.2006-1073. Epub 2006 Oct 24.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in Netherlands.
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 3 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 18 Jan 2017. 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 Netherlands. 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?
Insulin sensitivity (time frame: Index 5 years after end of GH treatment compared to controls). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787878, which also lists 1 linked publication.
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 18 Jan 2017.