| CTRI Number |
CTRI/2025/02/081437 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study Of the Relationship Between Cognitive Function, Duration And Control Of Type - 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Assessment of cognitive function in type 2 diabetes mellitus- An observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Bhatt |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College |
| Address |
Department of General Medicine Dr D Y Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8291711839 |
| Fax |
|
| Email |
shivanidileep1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Purkar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Medical College |
| Address |
Department of General Medicine Dr D Y Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9975498808 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Bhatt |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College |
| Address |
Department of General Medicine Dr D Y Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8291711839 |
| Fax |
|
| Email |
shivanidileep1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College And Hospital, Nerul, Navi Mumbai, Maharashtra, India - 400706. |
|
|
Primary Sponsor
|
| Name |
Shivani Bhatt |
| Address |
Junior Resident
Department of General Medicine, Dr D Y Patil Medical College, Navi Mumbai, maharashtra, India - 400706.
|
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 |
| Shivani Bhatt |
Dr D Y Patil Hospital. |
OPD-1 (General Medicine OPD), OPD -13 (Diabetic OPD), Female Medicine Ward, Male Medicine Ward, Dr D Y Patil Hospital, Navi Mumbai.
Thane
MAHARASHTRA |
8291711839
shivanidileep1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of type 2 diabetes mellitus, diagnosed for more than 2 years.
Above age of 18 years.
Patients of both genders giving consent for the study. |
|
| ExclusionCriteria |
| Details |
Type 1 diabetes cases.
Dementia patients.
Developmental disorders.
History of CVA.
Cases on drugs affecting cognitive function such as sedatives, neuroepileptics, antidepressants, anti psychotic drugs.
Alcoholics.
Known case of thyroid disorders.
Patient having electrolyte abnormalities and Acute febrile illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting sugar levels
post prandial sugar levels
HBA1C
Haemoglobin
Creatinine. |
1 year from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| co-relation between duration,control of blood sugar levels and cognitive function using MMSE score. |
1 year from baseline. |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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)
|
10/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is an observational study to know the effect of blood sugar control and duration of type 2 diabetes mellitus on cognitive function of patients using MMSE score. |