Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
NCT00396474
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- 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).
- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
- Familial dyslipidemia
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Descriptive Information | ||||
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Brief Title | Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height | |||
Official Title | Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls | |||
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. | |||
Detailed Description | case-control | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: whole blood, serum | |||
Sampling Method | Probability Sample | |||
Study Population | SGA Subjects treated or untreated with growth hormone | |||
Condition | Infant, Small for Gestational Age | |||
Intervention | Other: post GH treatment observational study
Intravenous glucose tolerance test (IVGTT) | |||
Study Groups/Cohorts | 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 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Withdrawn | |||
Actual Enrollment | 0 | |||
Original Enrollment | 90 | |||
Estimated Study Completion Date | January 2012 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00396474 | |||
Other Study ID Numbers | A6281279 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | April 2015 |