| 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
|
|
|
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
|
|
|
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
|
|
|
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. |