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临床试验/CTRI/2025/04/084660
CTRI/2025/04/084660尚未招募不适用

Diagnostic Utility of the ratio of Serum Insulin like Growth Factor-1 to its Serum Binding Protein-3 in Growth Hormone Deficiency in comparison to Clonidine Stimulation Test

KLE Academy of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To analyse serum IGF1 to serum IGFBP3 ratio in diagnosis of Growth Hormone Deficiency

研究概览

简要总结

**Title: “**Diagnostic utility of the ratio of Serum Insulin like Growth Factor-1 (IGF-1) to its Serum  Binding Protein-3 (IGFBP-3)  in Growth Hormone Deficiency in comparison to Clonidine Stimulation Test”

Growth hormone deficiency (GHD) is an important treatable cause of short stature (SS) in children. Its diagnosis however proves to be rather difficult because of a true gold standard diagnostic test. Classically hormonal evaluation for GHD is established by Growth Hormone Stimulation Test. However GH stimulation tests do not demonstrate perfect sensitivity or specificity allowing for potential false-negative or false-positive results. Other drawbacks of GH stimulation tests namely time-consuming invasive nonphysiological nonreproducible and potentially hazardous nature. It has motivated investigators to search for more promising diagnostic tools. Insulin like Growth Factor (IGF-1) concentration is most widely used for the diagnosis of GHD. However more than half the therapeutic response is accounted for by variability in the serum concentrations of IGF-1 and Insulin like Growth Factor Binding Protein (IGFBP-3). So IGF-1 and  IGFBP-3 molar  ratio is used as  biochemical marker to diagnose growth hormone deficiency. Very few studies have investigated the utility of serum IGF-1 to IGFBP-3 ratio in the diagnosis of GHD. This study aims to investigate the performance of the IGF-1, IGFBP-3  independently and in combination with serum IGF-1 and IGFBP-3  ratio and to compare GH stimulation test in the diagnosis of GHD in children with Short Stature.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • •All Children between 4-16years presenting to Paediatric and Paediatric Endocrinology OPD with Short Stature fulfilling the Clinical and/or Auxological criteria for Growth Hormone Deficiency.

排除标准

  • •Syndromic Short Stature Chronic Organic illness, Chronic Anaemia, Malnutrition, Chronic kidney disease, chronic liver disorders, Congenital Heart Disease Skeletal Dysplasia or other disorders of bone mineralization Untreated Hypothyroidism , Hypogonadism, Multiple Pituitary Hormone Deficiency.

结局指标

主要结局

To analyse serum IGF1 to serum IGFBP3 ratio in diagnosis of Growth Hormone Deficiency

时间窗: At Baseline

次要结局

  • To study diagnostic utility of Serum IGF1 in Growth Hormone Deficiency(To study diagnostic utility of Serum IGFBP3 in Growth Hormone Deficiency)

研究者

发起方
KLE Academy of Higher Education and Research
申办方类型
Research institution and hospital

研究点 (1)

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