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

Study Overview
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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.

Detailed Description
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case-control

Official Title
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Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls

Conditions
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Infant, Small for Gestational Age

Intervention / Treatment
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* Other: post GH treatment observational study


Participation Criteria
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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). Exclusion Criteria: Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2 Familial dyslipidemia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SGA patients<br>Infants born small for SGA who either received GH, no GH, or growth within normal ranges. | Other: post GH treatment observational study<br>* Intravenous glucose tolerance test (IVGTT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small for gestational age, Insulin Sensitivity Index, growth hormone treatment