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

Pfizer

Status: Withdrawn

Conditions: Infant, Small for Gestational Age

Treatments: Other: post GH treatment observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT00396474

A6281279

Details and patient eligibility

About

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.

Full description

case-control

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

SGA patients

Description:

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

Treatment:

Other: post GH treatment observational study