Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
Completed
- Conditions
- Foetal Growth ProblemSmall for Gestational Age
- Interventions
- Registration Number
- NCT00787878
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description C No treatment given - B No treatment given - A somatropin -
- Primary Outcome Measures
Name Time Method Insulin sensitivity Index 5 years after end of GH treatment compared to controls
- Secondary Outcome Measures
Name Time Method Disposition index, glucose effectiveness and acute insulin response compared to controls 5 years after end of Norditropin treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇳🇱Rotterdam, Netherlands