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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264641
• Other study ID #: 2005-2-15
• Status: Completed
• Phase: N/A
• First received: December 12, 2005
• Last updated: March 28, 2017
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2017
• Source: Hypoglycaemia Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Hypoglycemia

Intervention

Drug:
• Human insulin
Hyperinsulinaemic induced hypoglycaemia

Locations

Country	Name	City	State
Denmark	Medical Department I, Hillerød Hospital	Hillerød

Sponsors (2)

Lead Sponsor	Collaborator
Hypoglycaemia Research Group	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. 20 — View 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;2 — View 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 syst — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Activation During Hypoglycaemia	To compare the high RAS activity vs low RAS activity a Z score was used.	After 4 scans on day 1