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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
Intervention / Comparator Agent
|
|
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. |