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

Condition	Intervention
Hypoglycemia Cognitive Impairment	Drug: insulin

Further study details as provided by Hypoglycaemia Research Group:

Expected Total Enrollment:  20

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.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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)).

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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

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Please refer to this study by ClinicalTrials.gov identifier  NCT00264641

Lise Grimmeshave, MD      +4548294817    Ligri@fa.dk
Birger Thorsteinsson, MD, DMSci      +4548296403    Bith@fa.dk

Denmark
      Medical Department I, Hillerød Hospital, Hillerød,  3400,  Denmark

Study chairs or principal investigators

Birger Thorsteinsson, MD, DMSci,  Study Chair,  Hypoglycaemia Research Group   

Study ID Numbers:  2005-2-15
Last Updated:  December 12, 2005
Record first received:  December 12, 2005
ClinicalTrials.gov Identifier:  NCT00264641
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2006-01-10