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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Hypoglycaemia Research Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Hypoglycaemia Research Group
ClinicalTrials.gov Identifier:
NCT00264641
First received: December 12, 2005
Last updated: March 27, 2006
Last verified: March 2006
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Impact of Renin-Angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study

Resource links provided by NLM:


Further study details as provided by Hypoglycaemia Research Group:

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264641

Locations
Denmark
Medical Department I, Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hypoglycaemia Research Group
Rigshospitalet, Denmark
Investigators
Study Chair: Birger Thorsteinsson, MD, DMSci Hypoglycaemia Research Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00264641     History of Changes
Other Study ID Numbers: 2005-2-15
Study First Received: December 12, 2005
Last Updated: March 27, 2006
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hypoglycaemia Research Group:
Hypoglycemia
Cognitive impairment
PET
CalCAP

Additional relevant MeSH terms:
Hypoglycemia
Cognition Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014