跳至主要内容
临床试验/CTRI/2026/02/103818
CTRI/2026/02/103818尚未招募不适用

Establishing normative data for overnight dexamethasone suppression cortisol and ACTH in paediatric and adolescent population across different age groups

Seth GSMC and KEMH, Diamond Jubilee Society Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月2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
120
试验地点
1
主要终点
To establish normative data of cortisol and ACTH after overnight dexamethasone suppression in paediatric and adolescent populations (5-18 years)

研究概览

简要总结

This study aims to establish normal values of cortisol and ACTH after overnight dexamethasone suppression in children and adolescents aged 5 to 18 years. Cushing syndrome is rare in this age group and diagnosis is difficult because children often present with growth failure with weight gain rather than typical adult features. Current biochemical tests include overnight dexamethasone suppression test low dose dexamethasone suppression test and 24 hour urinary free cortisol. However pediatric specific reference values especially using modern testing methods are limited.

This prospective study will enroll 120 healthy participants attending endocrine or community medicine outpatient services. Eligible participants will undergo clinical evaluation and anthropometry. Dexamethasone will be given at a dose of 15 microgram per kilogram body weight with maximum 1 mg at 11 PM. Blood samples will be collected next morning at 8 to 9 AM for cortisol ACTH thyroid profile renal and liver function hemoglobin and serum dexamethasone level. Participants with cortisol above 1.8 microgram per deciliter will undergo further evaluation.

Hormone levels will be measured using chemiluminescent assays and dexamethasone levels by LCMS. Statistical analysis will compare quantitative and categorical variables with significance level of 0.05.The results aim to provide reliable pediatric reference cutoffs to improve diagnosis of Cushing syndrome.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • •healthy volunteers between 5-18 years willing to give consent/assent.

排除标准

  • •On drugs affecting dexamethasone metabolism • Acute illness, known medical disorder.

结局指标

主要结局

To establish normative data of cortisol and ACTH after overnight dexamethasone suppression in paediatric and adolescent populations (5-18 years)

时间窗: outcome will be assessed at baseline

次要结局

  • To establish normative data of cortisol & ACTH after overnight dexamethasone(outcome will be assessed at baseline)

研究者

发起方
Seth GSMC and KEMH, Diamond Jubilee Society Trust
申办方类型
Other [trust]
责任方
Principal Investigator
主要研究者

Tushar Bandgar

KEM Hospital

研究点 (1)

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