Official Title

The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    20
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
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.
Study Started
Jan 31
2006
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Results Posted
Mar 29
2017
Last Update
Mar 29
2017

Drug Human insulin

Hyperinsulinaemic induced hypoglycaemia

High RAS activity Experimental

10 healthy men were characterized by having high basal RAS activity.

Low RAS activity Experimental

10 healthy men were characterized by having either a low basal RAS activity.

Criteria

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

-

Summary

High RAS Activity

Low RAS Activity

All Events

Event Type Organ System Event Term

Cerebral Activation During Hypoglycaemia

To compare the high RAS activity vs low RAS activity a Z score was used.

All Study Participants

High RAS>Low RAS post entorhinal cortex

4.55
Z score

Low RAS>High RAS Right sup frontal gyrus

4.85
Z score

Total

20
Participants

Age, Continuous

26.5
years (Mean)
Standard Deviation: 5.2

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

High RAS Activity

Low RAS Activity