| CTRI Number |
CTRI/2024/10/075532 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The relationship between diabetic medications, blood sugar control, and the risk of dementia in people with type 2 Diabetes |
|
Scientific Title of Study
|
The rapport between anti diabetic medications,glycemic control in conjunction with risk of dementia in patients with Type II Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima zuhara banu |
| Designation |
student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences, |
| Address |
Dept.of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,Deralakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8547810866 |
| Fax |
|
| Email |
fathimazuharabanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NGSM Institute of Pharmaceutical sciences |
| Address |
Dept.of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,Deralakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NGSM Institute of Pharmaceutical sciences |
| Address |
Dept.of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,Deralakatte,Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE(Deemed to be university)Deralakatte, Mangalore,575018 |
|
|
Primary Sponsor
|
| Name |
NITTE(Deemed to be university),NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte ,Mangalore,575018 |
| Type of Sponsor |
Other [Educational institution] |
|
|
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 Chethan Subhramanya |
Justice K S Hegde Charitable Hospital |
Department of General Medicine ,Ground floor,Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
8762552454
chethansub@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with type-2 diabetes and are on antidiabetic medication
Age above 18 years
Gender - male and female
Stable diabetic patients
|
|
| ExclusionCriteria |
| Details |
Patients with known case of dementia.
Breast feeding and pregnant women
Patients diagnosed with type 1 diabetes
Patients who are already on dementia medications.
Patients on Vit B12 supplements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will determine risk of dementia in the age groups greater than 18 years of type 2 diabetic patients |
single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will analyse the relationship between anti-diabetic medication and glycaemic control with risk of dementia in type 2 DM. |
Single point. |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
28/10/2024 |
| 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
|
INTRODUCTION Diabetes is a leading global health crisis, significantly contributing to the prevalence of dementia, particularly through it’s impact on heart health and stroke risk, which are closely linked to cognitive decline.
OBJECTIVES 1) To identify the risk of occurrence of dementia in diabetic patients. 2) To determine the predictors for the risk of dementia among diabetic patients. 3) To analyze the rapport between anti-diabetic medication, glycemic control in conjunction with dementia risk in diabetic patient
METHODOLOGY A cross-sectional observational study will be conducted for a duration of six months among 138 participants. Who are diagnosed with T2DM aged>18 years and stable will be included. Dementia risk will be evaluated using the MoCA assessment scale at Department of General Medicine of Justice K S Hegde Charitable Hospital
|