| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
|
|
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. |