Clinical trial NCT00264641: The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
Official title: The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Cognitive Impairment
Keywords: Hypoglycemia
Cognitive impairment
PET
CalCAP
Lead sponsor: Hypoglycaemia Research Group
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2005-12-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

-

Primary outcomes:
measure: Cerebral Activation During Hypoglycaemia
timeFrame: After 4 scans on day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Medical Department I, Hillerød Hospital
Study officials:
affiliation: Hypoglycaemia Research Group
name: Birger Thorsteinsson, MD, DMSci
role: STUDY_CHAIR
References:
citation: Bie-Olsen LG, Pedersen-Bjergaard U, Kjaer TW, Lonsdale MN, Law I, Thorsteinsson B. Association between regional cerebral blood flow during hypoglycemia and genetic and phenotypic traits of the renin-angiotensin system. J Cereb Blood Flow Metab. 2009 Nov;29(11):1790-5. doi: 10.1038/jcbfm.2009.94. Epub 2009 Jul 8.
citation: Bie-Olsen LG, Pedersen-Bjergaard U, Kjaer TW, Lonsdale MN, Law I, Thorsteinsson B. Differences in cortical and pituitary activity in response to hypoglycaemia and cognitive testing in healthy men with different basal activity of the renin-angiotensin system. J Renin Angiotensin Aldosterone Syst. 2010 Sep;11(3):173-9. doi: 10.1177/1470320310364182. Epub 2010 Mar 9.
citation: Bie-Olsen LG, Kjaer TW, Pedersen-Bjergaard U, Lonsdale MN, Holst JJ, Law I, Thorsteinsson B. Changes of cognition and regional cerebral activity during acute hypoglycemia in normal subjects: A H2 15O positron emission tomographic study. J Neurosci Res. 2009 Jun;87(8):1922-8. doi: 10.1002/jnr.22002.