| CTRI Number |
CTRI/2024/03/064040 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in Brain volume with patients suffering from diabetes using MRI |
|
Scientific Title of Study
|
Evaluation of changes in brain volume of patients with Diabetes using 3D MRI |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subia Mahmood |
| Designation |
MSc. Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of medical imaging technology, Manipal college of health professions MAHE
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8210569942 |
| Fax |
|
| Email |
mahmoodsubia1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subia Mahmood |
| Designation |
MSc. Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of medical imaging technology, Manipal college of health professions MAHE
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8210569942 |
| Fax |
|
| Email |
mahmoodsubia1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrWinniecia Dkhar |
| Designation |
PHPHD,Medical Imaging Technology, Associate Professor and Head |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions MAHE
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8095372184 |
| Fax |
|
| Email |
winniecia.dkhar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Radio Diagnosis and Imaging
Kasturba medical college
Manipal
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Department of Radiodiagnosis and Imaging |
| Type of Sponsor |
Other [nil] |
|
|
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 Winniecia Dkhar |
Kasturba Medical College and Hospital |
Room No.3 Department of Radiodiagnosis and Imaging
Kasturba Medical College and Hospital Manipal Udupi Karnataka 576104
Udupi
KARNATAKA |
8095372184
winniecia.dkhar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with diabetes for minimum of 1-year clinical report |
|
| ExclusionCriteria |
| Details |
Patients who are on hormonal therapy and chemotherapy.
Patients who underwent brain surgeries.
Trauma of head.
Systemic disease affecting brain function.
Cardiovascular diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brain volume changes in Temporal lobe ,Hippocampal,
Posterior Circulate Gyrus, Grey Matter Volume, White Matter Volume,
Inf Temporal gyrus, Caudate Nucleus, Sup Temporal lobe, Inf Parietal lobe, Middle frontal gyrus,
Thalamus, Other regions will also be evaluated to see any changes in brain volume
|
Patients with one year history of diabetes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
21/03/2024 |
| 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="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
|
MRI Brain is not a standard care for patients suffering from Diabetes. This is an observational study of the brain volume among the diabetic patients. These patients are the one who are referred for MRI brain by their physicians for other diseases or findings. However the history of the patients will be taken if they have diabetes will taken as cases and patients without any history of diabetes as controls will be included in the study. Patient will be explained with the procedure and informed will be obtained. Patients will undergo MRI scans with Axial 3DSPGR and T1 FSE sequence. Pre-processing steps will be carried out using CAT-12 installed in SPM-12 software MRI DICOM images will be converted into NifTi format using MRI convert 2.1.0 Images will be normalized and segmented and will be subjected to homogeneity test for evaluation of image quality. Images with the overall image quality of more than 70% will be used for calculating brain volume. Brain region of interest will be assessed base on AAL(Automatic Anatomy Labelling) Version 3 for Diabetes. Brain volume will be calculated using estimate option in CAT-12 software |