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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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case-control

Conditions

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Infant, Small for Gestational Age

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SGA patients

Infants born small for SGA who either received GH, no GH, or growth within normal ranges.

post GH treatment observational study

Intervention Type OTHER

Intravenous glucose tolerance test (IVGTT)

Interventions

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post GH treatment observational study

Intravenous glucose tolerance test (IVGTT)

Intervention Type OTHER

Eligibility Criteria

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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).