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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infant, Small for Gestational Age
• Intervention / Treatment: Other: post GH treatment observational study

Detailed Description

case-control

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

SGA Subjects treated or untreated with growth hormone

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SGA patients; Infants born small for SGA who either received GH, no GH, or growth within normal ranges.	Other: post GH treatment observational study; Intravenous glucose tolerance test (IVGTT)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: November 6, 2006
• First Submitted That Met QC Criteria: November 6, 2006
• First Posted (Estimate): November 7, 2006

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Small for gestational age, Insulin Sensitivity Index, growth hormone treatment
• Other Study ID Numbers: A6281279