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 range18 Years – 24 Years

SexALL

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

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