Status:
COMPLETED
The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes
Lead Sponsor:
Vrije Universiteit Brussel
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral bloo...
Eligibility Criteria
Inclusion
- non-smoking T1D patients or matched healthy controls
- having diabetes for more than 1 year
- males and females older than 18 years
- stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
- adequate visual and auditory acuity to allow neuropsychological testing.
Exclusion
- participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
- history in the past 2 years of epileptic seizures or any major psychiatric disorder
- history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
- significant history of alcoholism or drug abuse
- unstable cardiac, renal, lung, liver, or other severe chronic disease
- hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure \<100 mmHg)
- pacemaker or other medical metal devices that precludes performing MRI,
- chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
- macrovascular complications
- retinopathy, nephropathy or neuropathy (microvascular complications)
Key Trial Info
Start Date :
November 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03452605
Start Date
November 20 2015
End Date
March 15 2017
Last Update
March 2 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.