临床试验/NCT00787878

NCT00787878已完成不适用

Comparison of Safety in Small for Gestational Age (SGA) Subjects Treated With Norditropin® (Somatropin) 5 Years Ago With Untreated SGA Subjects and With Normal Average for Gestational Age (AGA) Subjects

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 153 人开始时间: 2009年2月最近更新: 2017年1月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 153
试验地点: 1
主要终点: Insulin sensitivity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is conducted in Europe. The primary aim of this observational study is to compare the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin® with untreated small for gestational age (SGA) subjects and with average for gestational age (AGA) subjects.

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

年龄范围: 18 Years 至 24 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Norditropin® treated small for gestational age (SGA) group: Treated with Norditropin® for at least three years in the IUGR-1 or IUGR-2 trials
•Untreated small for gestational age (SGA) group: Birth length and/or weight less than -2 SDS for gestational age
•Average gestational age (AGA) group: Birth length and/or weight larger than -2 SDS for gestational age

排除标准

•Growth hormone deficiency defined as a peak growth hormone (GH) less than 20 mU/l
•Insulin like growth (IGF)-1 level less than -2 SDS
•Receipt of any investigational drug within four weeks prior to the trial

研究组 & 干预措施

C

干预措施: No treatment given (Drug)

A

干预措施: somatropin (Drug)

B

干预措施: No treatment given (Drug)

结局指标

主要结局

Insulin sensitivity

时间窗: Index 5 years after end of GH treatment compared to controls

次要结局

Disposition index, glucose effectiveness and acute insulin response compared to controls(5 years after end of Norditropin treatment)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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