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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:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Birger Thorsteinsson, Hypoglycaemia Research Group
ClinicalTrials.gov Identifier:
NCT00264641
First received: December 12, 2005
Last updated: March 28, 2017
Last verified: March 2017
  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: No masking
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Birger Thorsteinsson, Professor, Hypoglycaemia Research Group
ClinicalTrials.gov Identifier: NCT00264641     History of Changes
Other Study ID Numbers: 2005-2-15
Study First Received: December 12, 2005
Results First Received: January 22, 2016
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on June 28, 2017