HypoglycemiaNCT00264641
The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
A study testing Human insulin in people with Hypoglycemia and Cognitive Impairment, run by Hypoglycaemia Research Group at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Cognitive Impairment
- What is being tested?
- Human insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Department I, Hillerød Hospital
Hillerød, Hillerød, 3400
About this study
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
Read the 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.
- Conditions
- Hypoglycemia, Cognitive Impairment
- Being tested
- Human insulin
- Keywords
- Hypoglycemia, Cognitive impairment, PET, CalCAP
- Medical subject headings
- Hypoglycemia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human insulinDrug
Hyperinsulinaemic induced hypoglycaemia
| Study group | Role | What they receive |
|---|---|---|
| High RAS activity | Experimental | 10 healthy men were characterized by having high basal RAS activity. Receives: Drug: Human insulin |
| Low RAS activity | Experimental | 10 healthy men were characterized by having either a low basal RAS activity. Receives: Drug: Human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Activation During Hypoglycaemia
To compare the high RAS activity vs low RAS activity a Z score was used.
Measured: After 4 scans on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hypoglycaemia Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Birger Thorsteinsson, Hypoglycaemia Research Group
- Investigators
- Birger Thorsteinsson, MD, DMSci, Study chair, Hypoglycaemia Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264641
- Sponsor's protocol ID
- 2005-2-15
- Status last verified
- Mar 2017
- First submitted
- 12 Dec 2005
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19584889Bie-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.
PubMed 20215476Bie-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.
PubMed 19170163
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study
- ClinicalTrials.gov ID
- NCT00264641
- Acronym / sponsor ID
- 2005-2-15
- Conditions
- Hypoglycemia, Cognitive Impairment
- Keywords
- Hypoglycemia, Cognitive impairment, PET, CalCAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hypoglycaemia Research GroupUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Dec 2005 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High RAS activity | Experimental | Drug: Human insulin10 healthy men were characterized by having high basal RAS activity. |
| Low RAS activity | Experimental | Drug: Human insulin10 healthy men were characterized by having either a low basal RAS activity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human insulinHyperinsulinaemic induced hypoglycaemia | Drug | High RAS activity, Low RAS activity |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19584889Bie-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 publication: PubMed 20215476Bie-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 publication: PubMed 19170163Bie-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birger Thorsteinsson, MD, DMSci study chair
Hypoglycaemia Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human insulin in people with Hypoglycemia and Cognitive Impairment, run by Hypoglycaemia Research Group at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Activation During Hypoglycaemia (time frame: After 4 scans on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.