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

Withdrawn

• Conditions: Infant, Small for Gestational Age
• Interventions: Other: post GH treatment observational study

• Registration Number: NCT00396474
• Lead Sponsor: Pfizer

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

Detailed Description

case-control

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Study First Posted: 2006-11-07
• Study Start: 2009-01
• Study Completion: 2012-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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Exclusion Criteria

• Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
• Familial dyslipidemia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGA patients	post GH treatment observational study	Infants born small for SGA who either received GH, no GH, or growth within normal ranges.

Primary Outcome Measures

Name	Time	Method
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	90 days

Secondary Outcome Measures

Name	Time	Method
To demonstrate that blood pressure and lipid profile are not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH	90 days
To demonstrate that the ISI is not different between GH treated SGA subjects and an SGA cohort matched by gender and BMI and not treated with GH that achieved normal final height	90 days