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

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NCT00396474

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small for Gestational Age Infant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2

- Familial dyslipidemia

NCT00396474
Pfizer
Withdrawn
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height

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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.
case-control
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
whole blood, serum
Probability Sample
SGA Subjects treated or untreated with growth hormone
Infant, Small for Gestational Age
Other: post GH treatment observational study
Intravenous glucose tolerance test (IVGTT)
SGA patients
Infants born small for SGA who either received GH, no GH, or growth within normal ranges.
Intervention: Other: post GH treatment observational study
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2012
Not Provided

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: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00396474
A6281279
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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