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CTRI Number  CTRI/2024/08/072032 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Association between insulin resistance with gynaecological cancers in non-diabetic women  
Scientific Title of Study   Association between insulin resistance with endometrial, ovarian and cervical cancers in non-diabetic women : A Cross sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parish Kamdi 
Designation  Junior resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Obstetrics and Gynaecology, Level 6, A block, AIIMS Rishikesh, Shivaji Nagar, Virbhadra road, Rishikesh, Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  8806199249  
Fax    
Email  parishkamdi22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaya Chaturvedi 
Designation  Professor and Head of Department 
Affiliation  AIIMS Rishikesh 
Address  Department of Obstetrics and Gynaecology, Level 6, A block, AIIMS Rishikesh, Shivaji Nagar, Virbhadra road, Rishikesh, Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  9997310120  
Fax    
Email  jaya.obg@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Jaya Chaturvedi 
Designation  Professor and Head of Department 
Affiliation  AIIMS Rishikesh 
Address  Department of Obstetrics and Gynaecology, Level 6, A block, AIIMS Rishikesh, Shivaji Nagar, Virbhadra road, Rishikesh, Dehradun

Dehradun
UTTARANCHAL
249203
India 
Phone  9997310120  
Fax    
Email  jaya.obg@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Dr Parish Kamdi Department of Obstetrics and Gynaecology, Level 6, A block, AIIMS Rishikesh, Shivaji Nagar, Virbhadra road, Rishikesh, Dehradun, Uttaranchal-249203 
 
Primary Sponsor  
Name  Dr Parish Kamdi 
Address  AIIMS Rishikesh, Virbhadra road , Shivaji Nagar, Rishikesh, Dehradun 
Type of Sponsor  Other [Principle Investigator] 
 
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 Parish Kamdi   AIIMS Rishikesh  AIIMS Rishikesh, Virbhadra road, Shivaji Nagar, Rishikesh, Dehradun
Dehradun
UTTARANCHAL 		 8806199249

parishkamdi22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  -  - 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  All non-diabetic women with endometrial, ovarian and cervical cancers who are willing to participate 
 
ExclusionCriteria 
Details  Women with Diabetes Mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Homeostatic model assessment -insulin resistance calculated as fasting insulin (microU/L) X fasting plasma glucose (mol/L)  Once at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
Age, menopausal status, parity, history of contraception, smoking or drinking habits, education status, family history of female genital cancer, family history of diabetes, weight, height, BMI, waist circumference, hip circumference, blood pressure, lipid profile , fasting plasma glucose, fasting insulin, HbA1c.  Once at the time of recruitment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Insulin resistance (IR) refers to cells and tissues becoming insensitive to the peptide hormone, Insulin. It is well-established that hyperinsulinemia, a hallmark of IR, may play a role in tumorigenesis as well as IR is strongly associated with visceral adiposity dysfunction and systemic inflammation, both favouring the establishment of a pro-tumorigenic environment.  Polycystic ovary syndrome (PCOS) frequently shows IR accompanied by an increase of IGF-1 in plasma, being involved in the differentiation of various reproductive tissues, like endometrium and ovarian tissues. Metabolic Syndrome may contribute to viral-host interactions, which lead to persistent human papillomavirus (HPV) infection, leading to increased risk of cervical cancer. A higher risk for cervical, ovarian and endometrial cancer is related to high IGF-1 levels in post- and premenopausal women.   Many international studies have depicted the close association between IR and gynaecological malignancies. However, further evidence needs to be investigated as only a few studies have been published from the Indian subcontinent showing the association between insulin resistance and gynaecological cancers, and hence, this study has been planned to determine the association between insulin resistance and endometrial, ovarian and cervical cancer in non-diabetic women. The primary objective of the study is to evaluate the prevalence of Insulin resistance in non-diabetic women with endometrial, ovarian and cervical cancer. All non-diabetic women with endometrial, ovarian and cervical cancers willing to participate in the study will be recruited from Obstetrics and Gynaecology outpatient or inpatient departments at AIIMS Rishikesh for a period of one year and six months and blood samples will be collected from all patients in resting position and after 8–10 h of fasting and tested for fasting plasma glucose, fasting insulin, lipid profile and Hba1c. HOMA IR will be calculated with the help of fasting plasma glucose and fasting insulin and study population will be divided into two groups, insulin sensitive and insulin resistant and baseline characteristics (age, BMI, menopausal status), anthropometric measures, and metabolic parameters will be compared among insulin-resistant and insulin-sensitive groups. 
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