To study role of ultrasound elastography of pancreatic stiffness and its role in predicting presence of diabetes

Not yet recruiting

Conditions: Type 2 diabetes mellitus,

Registration Number: CTRI/2023/04/051841

Lead Sponsor: Maulana Azad Medical College

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 Youngâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

Adult healthy volunteers and patients diagnosed with prediabetes and diabetes.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To study the association of pancreatic stiffness values with presence of prediabetes and diabetes	Measurment of pancreatic stiffness values at time of presentation

Trial Locations

Locations (1): Maulana Azad Medical College, New Delhi
🇮🇳
Central, DELHI, India
Maulana Azad Medical College, New Delhi
🇮🇳Central, DELHI, India
Dr Rashmi Dixit
Principal investigator
9968604358
drrashmidixit@gmail.com