An observational study in Small Vessel Disease of Diabetes Mellitus, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Yale University · Observational
To develop a set of biomarkers for imaging of small vessel disease in diabetic individuals using advanced MRI techniques. With this the investigators want to document progression of disease both radiologically and clinically.
The investigators will use a paradigm developed at Yale University called Cognitive Predictive Modelling (CPM) which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. Vascular measures will complement this measure.
28 studies on the registry are indexed under Diabetic Angiopathies; 6 are open to participants now.
This study's enrollment of 63 is below the median of 123 across 12 observational studies indexed under Diabetic Angiopathies.
Browse Diabetic Angiopathies studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Our study population are those with type 2 diabetes in mid-life and old age, who may or may not have cognitive deficits, whose cognitive deficits (when present) cannot be better explained by other factors. We exclude those who are unable to have MRI or cognitive testing due to a variety of reasons.
A - Vascular cognitive impairment:
B- Cognitively normal elderly Subjects:
Exclusion Criteria:
These are individuals with diabetes who do not have vascular cognitive impairment as determined by VASCOG criteria.
Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.
These are individuals with diabetes who have vascular cognitive impairment as determined by VASCOG criteria.
Diagnostic Test: MRI including cf-MRI, DTI, ASL and CVR.
A paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures.
Also known as: Neuropsychological testing (Cantab), basic laboratory blood tests, small number of CSF
Diagnostic Odds ratio for the MRI vascular cognitive impairment biomarker.
This will be calculated from the sensitivity and specificity as compared to clinical diagnosis.
Time frame: 2 years
Correlation between the biomarker and cognition
Assess whether the biomarker can predict the severity of the cognitive performance.
Time frame: 18 months.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Yale University