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CTRI Number  CTRI/2023/04/051841 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 20/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study role of ultrasound elastography of pancreatic stiffness and its role in predicting presence of diabetes  
Scientific Title of Study   Comparative Evaluation of Pancreatic Elastography among Healthy Volunteers, Prediabetic patients and Diabetic patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rashmi Dixit 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Radiodiagnosis, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone    
Fax    
Email  drrashmidixit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashmi Dixit 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Radiodiagnosis, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi-110002

DELHI
110002
India 
Phone    
Fax    
Email  drrashmidixit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Dixit 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Radiodiagnosis, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi-110002

DELHI
110002
India 
Phone    
Fax    
Email  drrashmidixit@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Bahadur Shah Zafar Marg, New Delhi-110002 
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 Rashmi Dixit  Maulana Azad Medical College, New Delhi  Room no. 115, Department of Radiodiagnosis
Central
DELHI 
9968604358

drrashmidixit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult healthy volunteers and patients diagnosed with prediabetes and diabetes 
 
ExclusionCriteria 
Details  History of pancreatic disease such as pancreatitis, focal pancreatic lesion, pancreatic surgery
history of chronic liver disease due to any etiology
history of alcohol intake
pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Measurment of pancreatic stiffness values among non diabetic adult volunteers, patients with prediabete and patients with diabetes  Measurment of pancreatic stiffness values at time of presentation) 
 
Secondary Outcome  
Outcome  TimePoints 
To study the association of pancreatic stiffness values with presence of prediabetes and diabetes   Measurment of pancreatic stiffness values at time of presentation 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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)   01/05/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

India is the Diabetes Capital of the world as estimates from 2019 statistics showed that about 77 million people had Diabetes in India, which is going to increase to over 134 million by 2045[1]. Unfortunately, approximately 54 % of these people remain undiagnosed and present with complications leading to significant morbidity. Rising rates of prediabetes, diabetes, and diabetic microangiopathy complications not only in older adults but also among the young population of  India are of great concern.

 Recent research suggests that chronic inflammation plays a role in the development of diabetes and leads to pancreatic fibrosis. In DM, Hyperglycemia stimulates the proliferation of stellate cells and causes collagen deposition, whereas hypoinsulinemia inhibits the growth of pancreatic acinar cells. These alterations ultimately lead to pancreatic fibrosis with increased stiffness of pancreatic parenchyma [2].

Ultrasound-based elastography is a recent technology to assess tissue elasticity non-invasively and has opened new research areas to find alternatives for tissue diagnosis. The basic principle of elastography is to indirectly measure the elastic restoring properties(strain) of the tissue in response to deformation generated by the imparted force (stress).

After applying deforming force (stress), all elastography systems measure tissue displacement (strain), but they differ in how the measured displacement is used. It can be imaged directly as in strain imaging or can be used to calculate the arrival time of shear waves in shear wave imaging. In shear wave imaging, a dynamic force is needed to generate shear waves and measure their speed, whereas, for displacement or strain imaging, the force can be dynamic, quasi-static, or static.

There are three methods of ultrasound-based shear wave elastography techniques which are commonly used, namely 1D-Transient elastography (TE), point shear wave elastography (pSWE), and 2D shear wave elastography(2D-SWE). Two-dimensional (2D) SWE also uses acoustic radiation force like point shear wave elastography, but multiple focal zones are evaluated rapidly instead of a single focal zone. It emits ultrasound beams continuously at a speed greater than shear waves to different tissue depths, producing tissue displacements simultaneously, resulting in a conical pressure wavefront called Mach cone. It allows real-time generation of elastography maps from which multiple regions of interest can be placed to measure shear wave speed or Young’s modulus. The elasticity modulus is related to the resistance offered by the tissue to the wave propagation. Therefore the higher the shear wave velocity, the higher the tissue stiffness [3].

Clinical use of shear wave elastography has been established in the non-invasive assessment of liver fibrosis in gastroenterology and is expected to be a standard method for assessing liver fibrosis instead of liver biopsy in the near future. Few studies have also  demonstrated its usefulness for the pancreas too.

If the elasticity of the pancreas measured during routine abdominal ultrasound examination could give us clues to the presence of prediabetes and asymptomatic diabetes and identify high-risk groups for microangiopathy complications in known diabetic patients, its clinical implication would be tremendous.

Therefore, In the present study, we aim to prospectively evaluate pancreatic stiffness by two-dimensional shear wave elastography, establish the normal range in non diabetic adult volunteers, and compare the values among  volunteers, patients with prediabetes and patients with diabetes.

 
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