NCT00264641

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

December 12, 2005

Results QC Date

January 22, 2016

Last Update Submit

March 28, 2017

Conditions

HypoglycemiaCognitive Impairment

Keywords

HypoglycemiaCognitive impairmentPETCalCAP

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

High RAS activity

EXPERIMENTAL

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

Drug: Human insulin

Low RAS activity

EXPERIMENTAL

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

Drug: Human insulin

Interventions

Human insulinDRUG

Hyperinsulinaemic induced hypoglycaemia

High RAS activityLow RAS activity

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department I, Hillerød Hospital

Hillerød, Hillerød, 3400, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 19584889RESULT

  • 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.

    PMID: 20215476RESULT

  • 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.

    PMID: 19170163RESULT

MeSH Terms

Conditions

HypoglycemiaCognitive Dysfunction

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Prof. Birger Thorsteinsson
Organization
Hypoglycaemia Research Group
Birger.Thorsteinsson@regionh.dk
+4548294829

Study Officials

  • Birger Thorsteinsson, MD, DMSci

    Hypoglycaemia Research Group

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 29, 2017

Results First Posted

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)