Cognitive Impairment, Hypoglycemia
Conditions
Keywords
Hypoglycemia, Cognitive impairment, PET, CalCAP
Brief summary
The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively
Detailed description
The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively.
Interventions
DRUGHuman insulin
Hyperinsulinaemic induced hypoglycaemia
Sponsors
Rigshospitalet, Denmark
Hypoglycaemia Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Male Age 18-40 years Right-handed In good general health based on history High/low RAS activity (high ACE activity, A-allele for angiotensin II receptor (subtype 2) and high plasma angiotensinogen, or low ACE activity, low plasma angiotensinogen and not carrier of the A-allele for angiotensin II receptor (subtype 2)). \-
Exclusion criteria
Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Activation During Hypoglycaemia | After 4 scans on day 1 | To compare the high RAS activity vs low RAS activity a Z score was used. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High RAS Activity High RAS activity is defined in the protocol | 10 |
| Low RAS Activity Low RAS activity is defined in the protocol | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | High RAS Activity | Total | Low RAS Activity |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 4.8 | 26.5 years STANDARD_DEVIATION 5.2 | 27 years STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 10 Participants |
| Region of Enrollment Denmark | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Cerebral Activation During Hypoglycaemia
To compare the high RAS activity vs low RAS activity a Z score was used.
Time frame: After 4 scans on day 1
Population: Only data available is between group analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Study Participants | Cerebral Activation During Hypoglycaemia | Low RAS>High RAS Right sup frontal gyrus | 4.85 Z score |
| All Study Participants | Cerebral Activation During Hypoglycaemia | High RAS>Low RAS post entorhinal cortex | 4.55 Z score |