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

This study has been withdrawn prior to enrollment.
(Study design no longer relevant and no patients were recruited.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00396474
First received: November 6, 2006
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Infant, Small for Gestational Age
Other: post GH treatment observational study
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum


Estimated Enrollment: 90
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Groups/Cohorts Assigned Interventions
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)

Detailed Description:

case-control

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

SGA Subjects treated or untreated with growth hormone

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396474

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00396474     History of Changes
Other Study ID Numbers: A6281279
Study First Received: November 6, 2006
Last Updated: April 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Small for gestational age, Insulin Sensitivity Index, growth hormone treatment

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014