Type 1 Diabetes Mellitus
Conditions
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 blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.
Interventions
DIETARY_SUPPLEMENTcocoa flavanol supplementation
cocoa flavanols (containing 196 mg epicatechin)
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive function | 5 min | reaction time (milliseconds) on the flanker task |
| BOLD fmri response | 5 min | blood oxygenation level dependent response during flanker test |
Outcome results
None listed