Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

NCT ID: NCT00787878

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Foetal Growth Problem Small for Gestational Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

somatropin

Intervention Type DRUG

SGA previously treated with Norditropin®

B

No treatment given

Intervention Type DRUG

Untreated SGA

C

No treatment given

Intervention Type DRUG

AGA (Average gestational age)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

somatropin

SGA previously treated with Norditropin®

Intervention Type DRUG

No treatment given

Untreated SGA

Intervention Type DRUG

No treatment given

AGA (Average gestational age)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GHLIQUID

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Rotterdam, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17062774 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GHLIQUID-1975

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.