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CTRI Number  CTRI/2025/11/097513 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role and relations of insulin signal and resistance in Type 2 diabetes patients 
Scientific Title of Study   Interplay of insulin resistance, signaling disruption and inflammatory pathways in Type 2 diabetes mellitus: A cross-sectional analysis of circulatory biomarkers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachana S Menon 
Designation  Junior Academic Resident 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, All India Institute of Medical Sciences, Rajkot, Gujarat

Rajkot
GUJARAT
360006
India 
Phone  9496248170  
Fax    
Email  drrachana_menon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Parchwani 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, All India Institute of Medical Sciences, Rajkot, Gujarat

Rajkot
GUJARAT
360006
India 
Phone  7600024672  
Fax    
Email  drdparchwani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rachana S Menon 
Designation  Junior Academic Resident 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, All India Institute of Medical Sciences, Rajkot, Gujarat


GUJARAT
360006
India 
Phone  9496248170  
Fax    
Email  drrachana_menon@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  All India Institute Of Medical Sciences(AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 
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 Rachana S Menon  All India Institute Of Medical Sciences  Department of Medicine, AIIMS, Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006
Rajkot
GUJARAT 		 9496248170

drrachana.menon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult T2DM patients with atleast 2 years duration of Type 2 diabetes under treatment with oral anti-diabetic agents and/ or insulin.
 
 
ExclusionCriteria 
Details  Patients with preexisting macrovascular conditions, severe illness such as malignancy, severe infection, renal disease, respiratory disease, liver disease, impairment of speech, hearing, vision, or cognition, suffering from a serious diabetes complication, continuous or periodic use of corticosteroids; patients with type 1 presentation or continuous requirement of insulin within 1 year of diagnosis, pregnant females or those who had given birth within the preceding 6 weeks, or any medical condition that prevented participants from adhering to the protocol, lack of approval by physician and patients showing disinterest or refusal to sign the consent form.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Circulatory levels of Insulin, IRS-1, hsCRP and IL-6 in patients with T2DM stratified by UKPDS risk categories for macrovascular complications. Findings will help to identify the high-risk individuals, even before complications occur.  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   From existing literature on Type 2 DM, it is understood that with the development of insulin resistance there is an impairment in insulin sensitivity due to dysfunctional IRS-1 gene. Previous literature have also found that inflammatory mediators such as hsCRP and IL-6 interfere with the insulin signaling pathway by various mechanisms. However, there were discrepancies in independent studies done to find a link between IRS-1, hsCRP and IL-6 and the development of macrovascular complications in Type 2 DM. We hypothesize that there is a significant difference in insulin resistance markers, IRS-1 dysfunction, and inflammatory proteins such as hsCRP and IL-6 across UKPDS stratified risk categories in Type 2 DM patients and thus hope to develop a prediction model for cardiometabolic risk factors in these patients.  
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