WithdrawnNot Applicable

Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height

Stopped: Study design no longer relevant and no patients were recruited.

0Started 2009-01

Plain-language 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 matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.

Who can participate

SexALL

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

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

What they're measuring

To demonstrate, that the Insulin Sensitivity Index is not different between GH treated SGA and SGA cohort matched by gender and BMI and not treated with GH that remained short at final height

Timeframe: 90 days

Trial details

NCT IDNCT00396474

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Infant, Small for Gestational Age trials