Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
The purpose of this study is to demonstrate that insulin sensitivity is not different between
 growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort
 of subjects matched by gender and body mass index (BMI) who are not treated with growth
 hormone (GH) and who remain short at final height.
case-control
Inclusion Criteria:

 -  Patients with SGA treated with growth hormone in one of the following Genotropin
 studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and
 after having stopped GH treatment for 5-10 years

 -  Untreated SGA (based on birth weight and/or length below -2 standard deviations [SDs]
 for gestational age) matched to treated SGA by body mass index (+ or = 10%) and
 gender:

 -  Subjects born SGA with normal final height (within +/- 1.3 SD of their target
 height); or

 -  Subjects born SGA with short stature (height SDs > 1.3 below target at final
 height).

 Exclusion Criteria:

 -  Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2

 -  Familial dyslipidemia