Evaluation of changes in brain volume of patients with Diabetes using 3D MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Brain volume changes in Temporal lobe ,Hippocampal,
Study Overview
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed with diabetes for minimum of 1-year clinical report.
Exclusion Criteria
- •Patients who are on hormonal therapy and chemotherapy.
- •Patients who underwent brain surgeries.
- •Trauma of head.
- •Systemic disease affecting brain function.
- •Cardiovascular diseases.
Outcomes
Primary Outcomes
Brain volume changes in Temporal lobe ,Hippocampal,
Time Frame: Patients with one year history of diabetes
Posterior Circulate Gyrus, Grey Matter Volume, White Matter Volume,
Time Frame: Patients with one year history of diabetes
Inf Temporal gyrus, Caudate Nucleus, Sup Temporal lobe, Inf Parietal lobe, Middle frontal gyrus,
Time Frame: Patients with one year history of diabetes
Thalamus, Other regions will also be evaluated to see any changes in brain volume
Time Frame: Patients with one year history of diabetes
Secondary Outcomes
No secondary outcomes reported
Investigators
Subia Mahmood
Manipal College of Health Professions, MAHE, Manipal