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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00396474

Enrollment

Registered

2006-11-07

Start date

2009-01-31

Completion date

2012-01-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Small for Gestational Age

Keywords

Small for gestational age, Insulin Sensitivity Index, growth hormone treatment

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

Interventions

OTHERpost GH treatment observational study

Intravenous glucose tolerance test (IVGTT)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026