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临床试验/NCT03525171
NCT03525171已完成不适用

Comparison Between Euglycemic Hyperinsulinemic Clamp and Surrogate Indexes of Insulin Sensitivity in Children With Growth Hormone Deficiency.

University of Palermo2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Change in insulin sensitivity in GHD children

研究概览

简要总结

Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.

The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.

详细描述

The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of children affected by GH deficiency and to compare the clamp-derived index with the most commonly used surrogate indexes of insulin sensitivity.

In all patients the auxological and metabolic evaluation was performed at baseline and after 12 months of GH treatment, while in controls these evaluations were only performed at baseline. In all children the investigators measured body height, body mass index (BMI) and waist circumference (WC). A blood sample was drawn after an overnight fast for the measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30 min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin sensitivity the investigators used the insulin sensitivity index, a composite index derived from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a gold standard measurement of insulin sensitivity the investigators performed the euglycemic hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin and resistin after an overnight fast were also measured.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children
  • Prepubertal children

排除标准

  • Children with multiple hormone deficiency
  • Children receiving other hormonal replacement treatment
  • Pubertal children

研究组 & 干预措施

GHD children

Active Comparator

23 prepubertal children with isolated GHD consecutively admitted to the Section of Endocrinology of the University of Palermo during treated with GH for at least 12 months underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp

干预措施: euglycemic hyperinsulinemic clamp (Diagnostic Test)

controls

Placebo Comparator

12 prepubertal healthy subjects with short stature recruited among children referred for assessment of short stature as a control group at baseline underwent full metabolic evaluation including euglycemic hyperinsulinemic clamp

干预措施: euglycemic hyperinsulinemic clamp (Diagnostic Test)

结局指标

主要结局

Change in insulin sensitivity in GHD children

时间窗: baseline and after 12 months of GH treatment

insulin sensitivity degree derived from clamp was calculates and compared with other indexes of insulin sensitivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Giordano

Principa Investigator

University of Palermo

研究点 (2)

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