| CTRI Number |
CTRI/2024/11/076963 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of high blood sugar on cognition |
|
Scientific Title of Study
|
Impact of brain hyperglycemia on cognition: A multidisciplinary approach |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh R S |
| Designation |
Postdoctoral fellow |
| Affiliation |
Inter University Centre for Biomedical Research & Super Speciality Hospital |
| Address |
Centre for Developmental and Ageing Research
Inter University Centre for Biomedical Research and super Speciality Hospital
Mahatma Gandhi University Campus at Thalappady
RubberBoard PO
Kottayam
Kottayam
KERALA
686009
India |
| Phone |
9496370423 |
| Fax |
|
| Email |
rakeshrs77@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KP Mohanakumar |
| Designation |
Director |
| Affiliation |
Inter University Centre for Biomedical Research & Super Speciality Hospital |
| Address |
Centre for Developmental and Ageing Research
Inter University Centre for Biomedical Research and super Speciality Hospital
Mahatma Gandhi University Campus at Thalappady
RubberBoard PO
Kottayam
Kottayam
KERALA
686009
India |
| Phone |
7356763041 |
| Fax |
|
| Email |
iucbr@mgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh R S |
| Designation |
Postdoctoral fellow |
| Affiliation |
Inter University Centre for Biomedical Research and Super Speciality Hospital |
| Address |
Centre for Developmental and Ageing Research
Inter University Centre for Biomedical Research and Super Speciality Hospital
Mahatma Gandhi University Campus at Thalappady
Rubber Board PO
Kottayam
Kottayam
KERALA
686009
India |
| Phone |
9496370423 |
| Fax |
|
| Email |
rakeshrs77@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kerala State Higher Education Council
Science and Technology Museum Campus Vikas Bhavan PO
Thiruvananthapuram 695033 |
|
|
Primary Sponsor
|
| Name |
Kerala State Higher Education Council |
| Address |
Science and Technology Museum Campus
Vikas Bhavan PO
Thiruvananthapuram 695033 |
| Type of Sponsor |
Government funding agency |
|
|
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 Rakesh R S |
Inter University Centre for Biomedical Research & Super Speciality Hospital |
Mahatma Gandhi University Campus at Thalappady
Rubber Board P O
Kottayam
Kerala 686009
India
Kottayam
KERALA |
9496370423
rakeshrs77@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of IUCBR & SSH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals aged 35 to 50 years with HbA1C level below 5.7 |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals with HbA1C level below 5.7
Patient with T2DM with HbA1C level 6.5 or higher |
|
| ExclusionCriteria |
| Details |
History of neurological disorders
Presence of psychiatric conditions
Use of medications that affect cognitive function |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Understand the neural correlates underlying the reported cognitive deficit
2 Estimation of extent of cognitive decline |
Two years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of novel cognitive training programs |
Two years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2025 |
| 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="2"
Months="0"
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
|
To investigate the EEG correlates of mental slowing in patients
with Type 2 diabetes mellitus (T2DM) compared to age-matched healthy controls (HC), thirty
participants with clinically diagnosed T2DM and 30 age-matched controls between
the age of 35-50 years will be recruited. After taking written informed
consent, a 32-channel EEG will be recorded while the subject performs a Stroop
test, which accesses cognitive domains such as executive control, selection
attention, cognitive flexibility, and speed of processing. The subject will be
instructed to respond to the relevant stimulus factor. Responses will be taken
in the form of button presses. From the data, the accuracy and reaction time of
the responses will be extracted and compared between T2DM and HC. Similarly,
the EEG data corresponding to the subject’s response will be taken out and will
be compared between the two groups. The EEG data will be analyzed for Event-Related
Spectral Perturbation (ERSP) which is a time-frequency analysis method that
measures event-related changes, related to baseline, in spectral power evoked
by a stimulus. |