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CTRI Number  CTRI/2023/09/057814 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of changes in the blood of patients of exogenous Cushing syndrome which is caused by use and misuse of steroids for a long time  
Scientific Title of Study   Investigation of the metabolic alterations in the serum of patients with exogenous Cushing syndrome 
Trial Acronym  MeXOS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sowrabha Bhat 
Designation  Assistant Professor 
Affiliation  Yenepoya Medical College 
Address  Yenepoya Medical College, University Road, Derlakatte, Mangalore.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448297016  
Fax    
Email  sowrabhas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sowrabha Bhat 
Designation  Assistant Professor 
Affiliation  Yenepoya Medical College 
Address  Yenepoya Medical College, University Road, Derlakatte, Mangalore.


KARNATAKA
575018
India 
Phone  9448297016  
Fax    
Email  sowrabhas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sowrabha Bhat 
Designation  Assistant Professor 
Affiliation  Yenepoya Medical College 
Address  Yenepoya Medical College, University Road, Derlakatte, Mangalore.


KARNATAKA
575018
India 
Phone  9448297016  
Fax    
Email  sowrabhas@gmail.com  
 
Source of Monetary or Material Support  
Seed grant from Yenepoya (Deemed to be) University, University Road, Derlakatte, Mangalore, Karnataka, 575018. 
 
Primary Sponsor  
Name  Yenepoya University 
Address  University Road, Derlakatte  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preyander Singh Thakur  All India Institute of Medical Sciences  Bilaspur, Himachal Pradesh
Bilaspur
HIMACHAL PRADESH 		 9418008966

preyander.thakur@gmail.com 
Dr Basavaraj G S  Narayana Hospitals   Bommasandra,HSR layout, Bangalore
Bangalore
KARNATAKA 		 9816038562

basavpgi@gmail.com 
Dr Sowrabha Bhat   Yenepoya Medical College  University Road, Derlakatte, Mangalore - 575018
Dakshina Kannada
KARNATAKA 		 9448297016

sowrabhas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bilaspur, HP.   Submittted/Under Review 
Narayana Health Academic Ethics Committee, Narayana Health Hospital, Bengaluru, Karnataka.   Approved 
Yenepoya Ethics Committee 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E249||Cushings syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Exogenous Cushing case greater than 18 years
2. History of steroid administration for 3 weeks or more
3. At least 2 features of Cushing syndrome
4. A suppressed 8 AM cortisol 
 
ExclusionCriteria 
Details  1. Critically ill patients
2. Endogenous Cushing syndrome
3. Patients younger than 18 years
4. Absence of Cushing features despite suppressed cortisol levels 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of metabolic markers of various manifestations of exogenous Cushing syndrome such as hypertension, diabetes, Cushingoid striae, fractures.
Categorization of metabolic markers according to severity of Cushingoid features.  		 At baseline.  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/09/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Exogenous Cushing is the most common type of Cushing syndrome . With wide availability of steroids over the counter and their increasing use and abuse there is a rising number of exogenous Cushing syndrome cases. The determinants of the various side effects of steroids and their possible predictors are not yet known. A preliminary assessment of the metabolic alterations in the serum of patients with exogenous Cushing syndrome may throw light on the possible molecular mechanisms associated with specific clinical features of Cushing syndrome and may pave the way for discovery of multiple potential therapeutic avenues in the form of candidate molecular targets for the prevention and treatment of exogenous Cushing syndrome. 

Research question: Can we identify a set of specific altered molecules associated with exogenous Cushing syndrome and which may segregate with diverse additional clinical features manifesting in different patients ?
 
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