Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls

Pfizer0 个研究点开始时间: 2009年1月最近更新: 2015年4月22日

适应症

试验速览

阶段: 不适用
状态: 撤回
发起方: Pfizer
主要终点: 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

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

case-control

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 是

入选标准

•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).

排除标准

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

结局指标

主要结局

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

时间窗: 90 days

次要结局

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)

研究者

发起方

Pfizer

申办方类型

Industry

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