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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00396474

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 IV

Study Type:	Observational
Study Design:	Case Control, 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:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

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

Biospecimen Description:

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Insulin

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009