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CTRI Number  CTRI/2024/03/063793 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Changes in hormonal levels of cortisol and ACTH after taking dexamethasone tablet in the night  
Scientific Title of Study   ACTH and cortisol dynamics after overnight dexamethasone suppression 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol version 1.0 dated 10th October 2023  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saba Memon 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9971247224  
Fax    
Email  sabasamadmemon@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saba Memon 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9971247224  
Fax    
Email  sabasamadmemon@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saba Memon 
Designation  Assistant Professor 
Affiliation  Seth GSMC and KEMH 
Address  Seth GSMC and KEMH, Department of Endocrinology, OPD Building,1st Floor, OPD 103, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9971247224  
Fax    
Email  sabasamadmemon@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College Multidisciplinary Research Unit 
 
Primary Sponsor  
Name  Seth GS Medical College Multidisciplinary Research Unit 
Address  MRU, 2nd floor, Mortuary Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai 
Type of Sponsor  Government medical college 
 
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 
Dr Saba Memon  Seth GS Medical College and KEM Hospital  Department of Endocrinology KEM hospital Acharya Donde Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 
9971247224

sabasamadmemon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Seth GSMC and KEMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cushings 
Patients  (1) ICD-10 Condition: K732||Chronic active hepatitis, not elsewhere classified, (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: E243||Ectopic ACTH syndrome, (5) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (6) ICD-10 Condition: E248||Other Cushings syndrome, (7) ICD-10 Condition: E240||Pituitary-dependent Cushings disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diagnostic intervention - Serum hormonal investigations  Basal ACTH and cortisol will be measured. Repeat ACTH and cortisol will be measured next day at 8AM and 4PM after overnight 1 mg dexamethasone administration at 11PM Blood testing will be done over 2 days for each study subject 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Newly diagnosed cushings
Cushings post surgery or radiotherapy
Chronic active hepatitis
Depressive disorder
CKD stage 4 and 5
Women on oral contraceptive pills
Healthy controls 
 
ExclusionCriteria 
Details  Exogenous cushings
Drugs affecting dexamethasone metabolism
Pregnancy and breastfeeding
Acute illness
Liver cirrhosis 
 
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 ACTH and cortisol after overnight dexamethasone suppression in various patient groups  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL
 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "230"
Final Enrollment numbers achieved (India)="230" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 22/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

The Endocrine society clinical practice guidelines recommend use of the 1-mg overnight dexamethasone suppression test (ONDST) to exclude autonomous cortisol excess and the cutoff suggested for exclusion of autonomous cortisol secretion in a post-dexamethasone sample is < 50 nmol/L (< 1.8 ug/dL). ONDST has a very high sensitivity of 98.6% and a specificity of 90.6%.  However, variable absorption and metabolism of dexamethasone by drugs causing induction/inhibition of hepatic clearance enzymes may affect the test results. False positive results were also noted in upto 50% of women taking oral contraceptive pills due to increased CBG levels. Certain psychiatric disorders like depression, anxiety disorder and obsessive-compulsive disorder are associated with mild hypercortisolism due to upregulated hypothalamic-pituitary-adrenal (HPA) axis which may cause abnormal dexamethasone suppressibility and produce false positive results. Outcome of ONDST may be affected by wide inter-individual variability in serum dexamethasone concentrations achieved after administration of 1 mg dexamethasone and hence concurrent serum dexamethasone levels     should be measured so that this information may be taken into consideration when interpreting ONDST results. Dexamethasone acts by direct suppression of hypothalamic-pituitary-adrenal (HPA) axis. The suppressed cortisol levels are due to the negative feedback of exogenous dexamethasone on the hypothalamic and pituitary glucocorticoid receptors which leads to decreased corticotropin releasing hormone (CRH) and adreno-corticotropic hormone (ACTH) production respectively. In theory, measuring ACTH levels rather than cortisol levels in the post-dexamethasone sample should more accurately reflect the intactness of the HPA axis regulation. Also, in conditions with alteration in CBG levels leading to falsely low or high total cortisol values, measuring ACTH after ONDST might better reflect dexamethasone suppressibility. Data showing ACTH and cortisol dynamics after ONDST is scarce in the existing literature. Hence, we intend to establish a normative data for overnight dexamethasone suppressed ACTH and cortisol levels in various patient groups

 
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