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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264641
First Posted: December 13, 2005
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Birger Thorsteinsson, Hypoglycaemia Research Group
  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: Human insulin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Birger Thorsteinsson, Hypoglycaemia Research Group:

Primary Outcome Measures:
  • Cerebral Activation During Hypoglycaemia [ Time Frame: After 4 scans on day 1 ]
    To compare the high RAS activity vs low RAS activity a Z score was used.


Enrollment: 20
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High RAS activity
10 healthy men were characterized by having high basal RAS activity.
Drug: Human insulin
Hyperinsulinaemic induced hypoglycaemia
Experimental: Low RAS activity
10 healthy men were characterized by having either a low basal RAS activity.
Drug: Human insulin
Hyperinsulinaemic induced hypoglycaemia

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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)).

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Birger Thorsteinsson, Professor, Hypoglycaemia Research Group
ClinicalTrials.gov Identifier: NCT00264641     History of Changes
Other Study ID Numbers: 2005-2-15
First Submitted: December 12, 2005
First Posted: December 13, 2005
Results First Submitted: January 22, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Hypoglycemia
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs