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

Primary Purpose

Hypoglycemia, Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Human insulin

About this trial

This is an interventional other trial for Hypoglycemia focused on measuring Hypoglycemia, Cognitive impairment, PET, CalCAP

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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 -

Sites / Locations

Medical Department I, Hillerød Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High RAS activity

Low RAS activity

Arm Description

10 healthy men were characterized by having high basal RAS activity.

10 healthy men were characterized by having either a low basal RAS activity.

Outcomes

Primary Outcome Measures

Cerebral Activation During Hypoglycaemia

To compare the high RAS activity vs low RAS activity a Z score was used.

Secondary Outcome Measures

Full Information

NCT ID

NCT00264641

First Posted

December 12, 2005

Last Updated

March 28, 2017

Sponsor

Hypoglycaemia Research Group

Collaborators

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00264641

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hypoglycaemia Research Group

Collaborators

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia, Cognitive Impairment

Keywords

Hypoglycemia, Cognitive impairment, PET, CalCAP

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High RAS activity

Arm Type

Experimental

Arm Description

10 healthy men were characterized by having high basal RAS activity.

Arm Title

Low RAS activity

Arm Type

Experimental

Arm Description

10 healthy men were characterized by having either a low basal RAS activity.

Intervention Type

Drug

Intervention Name(s)

Human insulin

Intervention Description

Hyperinsulinaemic induced hypoglycaemia

Primary Outcome Measure Information:

Title

Cerebral Activation During Hypoglycaemia

Description

To compare the high RAS activity vs low RAS activity a Z score was used.

Time Frame

After 4 scans on day 1

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Birger Thorsteinsson, MD, DMSci

Organizational Affiliation

Hypoglycaemia Research Group

Official's Role

Study Chair

Facility Information:

Facility Name

Medical Department I, Hillerød Hospital

City

Hillerød

ZIP/Postal Code

3400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19584889

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;29(11):1790-5. doi: 10.1038/jcbfm.2009.94. Epub 2009 Jul 8.

Results Reference

result

PubMed Identifier

20215476

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 system. J Renin Angiotensin Aldosterone Syst. 2010 Sep;11(3):173-9. doi: 10.1177/1470320310364182. Epub 2010 Mar 9.

Results Reference

result

PubMed Identifier

19170163

Citation

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. 2009 Jun;87(8):1922-8. doi: 10.1002/jnr.22002.

Results Reference

result

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

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