Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
NCT ID: NCT00787878
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
153 participants
OBSERVATIONAL
2009-02-28
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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A
somatropin
SGA previously treated with Norditropin®
B
No treatment given
Untreated SGA
C
No treatment given
AGA (Average gestational age)
Interventions
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somatropin
SGA previously treated with Norditropin®
No treatment given
Untreated SGA
No treatment given
AGA (Average gestational age)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Insulin like growth (IGF)-1 level less than -2 SDS
* Receipt of any investigational drug within four weeks prior to the trial
18 Years
24 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Rotterdam, , Netherlands
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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GHLIQUID-1975
Identifier Type: -
Identifier Source: org_study_id
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