Status:
WITHDRAWN
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
Lead Sponsor:
Pfizer
Conditions:
Infant, Small for Gestational Age
Eligibility:
All Genders
Brief Summary
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 ma...
Detailed Description
case-control
Eligibility Criteria
Inclusion
- 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
- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
- Familial dyslipidemia
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00396474
Start Date
January 1 2009
End Date
January 1 2012
Last Update
April 22 2015
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