NCT00396474

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

First QC Date

November 6, 2006

Last Update Submit

April 21, 2015

Conditions

Infant, Small for Gestational Age

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

SGA patients

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

Other: post GH treatment observational study

Interventions

post GH treatment observational studyOTHER

Intravenous glucose tolerance test (IVGTT)

SGA patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

SGA Subjects treated or untreated with growth hormone

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

January 1, 2009

Study Completion

January 1, 2012

Last Updated

April 22, 2015

Record last verified: 2015-04