CompletedNot Applicable

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

Netherlands153 participantsStarted 2009-02

Plain-language 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.

Who can participate

Age range

18 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insulin sensitivity

Timeframe: Index 5 years after end of GH treatment compared to controls

Trial details

NCT IDNCT00787878

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-01

View on ClinicalTrials.gov More Foetal Growth Problem trials

Who can participate

Age range

18 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.