Trial Outcomes & Findings for The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study (NCT NCT00264641)
NCT ID: NCT00264641
Last Updated: 2017-03-29
Results Overview
To compare the high RAS activity vs low RAS activity a Z score was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
After 4 scans on day 1
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
High RAS Activity
High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A
|
Low RAS Activity
Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Initiation of the Study
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
Baseline characteristics by cohort
| Measure |
High RAS Activity
n=10 Participants
High RAS activity is defined in the protocol
|
Low RAS Activity
n=10 Participants
Low RAS activity is defined in the protocol
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
27 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 4 scans on day 1Population: Only data available is between group analysis
To compare the high RAS activity vs low RAS activity a Z score was used.
Outcome measures
| Measure |
All Study Participants
n=20 Participants
From a screening population ten subjects with high RAS activity - defined as serum ACE and plasma angiotensinogen concentrations in the highest quartile in the population combined with presence of AT2 receptor genotype A corresponding to low expression of the receptor (maximum stimulation via the AT1 receptor) - were selected And 10 males with low RAS activity - defined as serum ACE and plasma angiotensinogen concentrations in the lowest quartile in the population combined with the presence of AT2 receptor genotype G corresponding to high expression of the receptor (58) (minimum stimulation via the AT1 receptor) were selected
|
|---|---|
|
Cerebral Activation During Hypoglycaemia
High RAS>Low RAS post entorhinal cortex
|
4.55 Z score
|
|
Cerebral Activation During Hypoglycaemia
Low RAS>High RAS Right sup frontal gyrus
|
4.85 Z score
|
Adverse Events
High RAS Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low RAS Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place