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CTRI Number  CTRI/2026/02/103818 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Measuring Normal Cortisol and ACTH Levels After an Overnight Dexamethasone Test in Young People 
Scientific Title of Study   Establishing normative data for overnight dexamethasone suppression cortisol and ACTH in paediatric and adolescent population across different age groups 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tushar Bandgar  
Designation  Head of Department  
Affiliation  KEM Hospital 
Address  OPD 103, Dept of Endocrinology, Registration Block 1st floor, KEM Hospital campus, Acharya Donde Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  982005037  
Fax    
Email  drtusharb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tushar Bandgar  
Designation  Head of Department  
Affiliation  KEM Hospital 
Address  OPD 103, Dept of Endocrinology, Registration Block 1st floor, KEM Hospital campus, Acharya Donde Marg, Parel, Mumbai Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  982005037  
Fax    
Email  drtusharb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayush Singla 
Designation  Senior resident 
Affiliation  King edward memorial hospital, 
Address  Shantiniketan hostel room no6 prabhadevi

Mumbai
MAHARASHTRA
400013
India 
Phone  7015073535  
Fax    
Email  singlaayush97@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Seth GSMC and KEMH, Diamond Jubilee Society Trust 
Address  First Floor, College building, KEM Hospital, Acharya Donde Marg, Parel, Mumbai - 400012 
Type of Sponsor  Other [Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayush Singla  Seth G.S. Medical College and King Edward Memorial Hospital  Room No. 102, Endocrine Department, Division of Endocrinology
Mumbai
MAHARASHTRA 
7015073535

singlaayush97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee II, Seth GS Medical College, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 5-18 years volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  healthy volunteers between 5-18 years
willing to give consent/assent 
 
ExclusionCriteria 
Details  • On drugs affecting dexamethasone metabolism
• Acute illness, known medical disorder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To establish normative data of cortisol and ACTH after overnight dexamethasone suppression in paediatric and adolescent populations (5-18 years)  outcome will be assessed at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To establish normative data of cortisol & ACTH after overnight dexamethasone   outcome will be assessed at baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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