| CTRI Number |
CTRI/2025/03/082350 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Memory assessment in Diabetic Patient |
|
Scientific Title of Study
|
A mobile application Montreal cognitive assessment in Diabetic patients with correlation with hippocampal volume |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharath Chandra |
| Designation |
Postgraduate, General Medicine |
| Affiliation |
Saveetha Medical College |
| Address |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
09908425942 |
| Fax |
|
| Email |
sharathc30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saranya C |
| Designation |
Professor, Department of Rheumatology |
| Affiliation |
Saveetha Medical College and hospital |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
09080574637 |
| Fax |
|
| Email |
drcsaranya1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharath Chandra |
| Designation |
Postgraduate, General Medicine |
| Affiliation |
Saveetha Medical College |
| Address |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
09908425942 |
| Fax |
|
| Email |
sharathc30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai-602105 |
| Type of Sponsor |
Private 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 Sharath Chandra |
Saveetha Medical College and Hospital |
Room no.1, Department of General Medicine, Saveetha Medical College and Hospital,Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU |
09908425942
sharathc30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Type-2 diabetes mellitus |
|
| ExclusionCriteria |
| Details |
1. Diabetics who are pregnant/ lactating
2.Diabetics who are unwilling to give consent.
3. Any other Neurological illness.
4.Any other autoimmune diseases
5. Any psychiatry illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To anticipate that the mobile MOCA application will demonstrate validity and reliability in cognitive screening among diabetic patients. To identify correlation between cognitive performance and hippocampal volume. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of diabetes, glycemic control and quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study introduces a novel method for assessing cognitive function in diabetic patients by combining the Montreal Cognitive Assessment (MOCA) tool with advanced neuroimaging to measure hippocampal volume. The aim is to provide a comprehensive approach for early detection and management of cognitive decline, which is often associated with diabetes. The system integrates cognitive screening with brain imaging to create a detailed cognitive profile, helping clinicians identify early signs of impairment and guide personalized treatment. This approach could improve diagnostic accuracy and support better outcomes for diabetic patients at risk of neurodegenerative conditions. |