Type 2 Diabetes Mellitus Clinical Trial
Official title:
Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes
Our goal is to determine the acute effects of intranasal insulin on regional perfusion and
cognition of older adults. We propose a pilot study to examine the effect of a single dose of
intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with
T2DM and 30 healthy controls >50 years old using a double blinded, placebo-controlled,
cross-over design.
Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in
older patients with T2DM as compared with placebo and compared with the control group.
Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory
and executive function in diabetic patients as compared with placebo and compared with
control group.
Type 2 diabetes mellitus (T2DM) is a major risk factor for vascular dementia. DM alters
insulin transport across blood-brain barrier affecting perfusion and neuronal function.
Intranasal administration enables effective delivery of insulin to the brain. Clinical
studies demonstrated improvement of cognitive function and memory in healthy and cognitively
impaired people.
Aim 1: To determine the acute effects of a single 40-IU dose of intranasal insulin vs.
placebo on regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous
arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. We will use
transcranial Doppler to determine the effects on intranasal insulin vs. placebo on cerebral
autoregulation based on measurements of beat-to-beat pressure flow velocity relationship.
Aim 2: To determine whether intranasal insulin improves cognitive functioning in older T2DM
patients as compared with placebo and the control group.
This translational study will address an important area about the effects of intranasal
insulin on cerebral blood flow regulation and cognition in older diabetics that has not been
studied. Intranasal insulin administration may provide a novel therapeutic target for
prevention and treatment of microvascular disease and cerebrovascular complications of T2DM.
If successful, this approach may have significant impact on the clinical management of large
population of older adults with T2DM.
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