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CTRI Number  CTRI/2020/11/028880 [Registered on: 04/11/2020] Trial Registered Prospectively
Last Modified On: 03/11/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A non-invasive approach for risk evaluation of Type 2 Diabetes and Hypertension for patients who are at-risk 
Scientific Title of Study   A non-invasive approach for Type 2 Diabetes and Hypertension risk evaluation in at-risk patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gayathri Choda 
Designation  CEO 
Affiliation  Aarca Research India Pvt Ltd 
Address  Gayathri Choda CEO, 76, Sanskriti Signet, 100 Feet Road, BTM Layout 2nd Stage Bangalore

Bangalore
KARNATAKA
560076
India 
Phone  9963522288  
Fax    
Email  gchoda@aarcaresearch.com  
 
Details of Contact Person
Scientific Query
 
Name  DrTJayanthi  
Designation  Associate Professor 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Biomedical Engineering
Kattankulathur Chengalpattu
Kancheepuram
TAMIL NADU
603203
India 
Phone  9840490315  
Fax    
Email  jayantht@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Gayathri Choda 
Designation  CEO 
Affiliation  Aarca Research India Pvt Ltd 
Address  Ms. Gayathri Choda CEO, 76, Sanskriti Signet, 100 Feet Road, BTM Layout 2nd Stage

Bangalore
KARNATAKA
560076
India 
Phone  9963522288  
Fax    
Email  gchoda@aarcaresearch.com  
 
Source of Monetary or Material Support  
Aarca Research India Pvt Ltd 76, Sanskriti Signet, 100 Feet Road, BTM Layout 2nd Stage Bengaluru - 560076 Karnataka 
 
Primary Sponsor  
Name  Aarca Research India Pvt Ltd 
Address  76, Sanskriti Signet, 100 Feet Road, BTM Layout 2nd Stage Bangalore  
Type of Sponsor  Other [Private Company] 
 
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 J S Kumar  SRM Medical College Hospital and Research Centre  Professor, Dept. of General Medicine, SRM Medical College Hospital and Research Centre Kattankulathur Chengalpattu District Tamil Nadu
Kancheepuram
TAMIL NADU 
9840047678

drkumarjs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age greater than 30 years with one or more of the following risk factors:
BMI > 25 kg/m²
Elevated waist circumference, > 35 inches for women and > 40 inches for men
Habitually physically inactive (does not exercise regularly)
Has delivered a baby weighing > 4kg or diagnosed with gestational diabetes
Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
Has insulin resistance which can be identified using HOMMA-IR modelling
Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last three years

 
 
ExclusionCriteria 
Details  Under 25 years of age
Receiving investigational treatments in the past 14 days
Psychosocial issues that interfere with an ability to follow study procedures
Current chemotherapy, or chemotherapy within the past 12 months
Receiving medications that fluoresce
Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the trial will be a model based evaluation system to identify at risk type 2 diabetes patients  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be identifying patients who are at risk for vascular complications like hypertension   8 weeks 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/11/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

  Background:

Currently, Type 2 diabetes can be diagnosed by testing a person’s blood for glucose levels. There are several blood glucose tests that may be used, including fasting plasma glucose (FPG), random capillary glucose (RCG) and oral glucose tolerance (OGTT) tests. The OGTT has been considered the standard test. The OGTT test involves someone fasting overnight before blood is taken the next morning from a vein in their arm. HbA1c tests reflect the average level of glucose in the blood over a period of a few months and do not require fasting. They can be conducted on either blood taken from a vein in the arm or, in some cases, a drop of blood from a finger-prick. Because blood glucose or HbA1c tests involve drawing blood and/or fasting, they may be considered inconvenient for mass screening for type 2 diabetes. Thermography, which combines a high degree of accuracy with complete safety, meets the need. Thermography involves the detection of heat energy by an infrared-sensitive device, with subsequent conversion to electrical energy, amplification, and a suitable means of display. Our invention is based on the principle of using the temperature distribution observed in the body to measure the parameters indicating the structural and functional characteristics of the vascular metabolism.

Justification:    The functioning of the vital organs is associated with metabolic heat, which is transferred to the skin surface by the circulating blood. As the heat emitted from the skin, which has an emissivity of 0.98 is related to blood flow. Measurement of the heat emission gives an indicative measure of blood flow. Any dysfunction, namely atherosclerosis that occurs in blood vessels causes the heat distribution observed to differ from the heat distribution of the skin observed under healthy conditions. Vascular dysfunction in a person creates vascular complications, such as endothelial dysfunction and atherosclerosis over time. These vascular impairments are becoming prominent in subjects who are developing these chronic conditions or existing patients. Our invention uses biomarkers associated with vascular structure and functions measured from thermal imaging for assessing vascular health. This vascular health provides an early indication of the development of diabetes and hypertension.

 
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