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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High RAS activity | Experimental | 10 healthy men were characterized by having high basal RAS activity. |
|
| Low RAS activity | Experimental | 10 healthy men were characterized by having either a low basal RAS activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human insulin | Drug | Hyperinsulinaemic induced hypoglycaemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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)).
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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
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| Name | Affiliation | Role |
|---|---|---|
| Birger Thorsteinsson, MD, DMSci | Hypoglycaemia Research Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department I, Hillerød Hospital | Hillerød | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19584889 | Result | 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. | |
| 20215476 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | High RAS Activity | High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A |
| FG001 | Low RAS Activity | Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High RAS Activity | High RAS activity is defined in the protocol |
| BG001 | Low RAS Activity | Low RAS activity is defined in the protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cerebral Activation During Hypoglycaemia | To compare the high RAS activity vs low RAS activity a Z score was used. | Only data available is between group analysis | Posted | Number | Z score | After 4 scans on day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High RAS Activity | High RAS activity is described in the protocol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Birger Thorsteinsson | Hypoglycaemia Research Group | +4548294829 | Birger.Thorsteinsson@regionh.dk |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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. |
| 19170163 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Only men were included | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Low RAS Activity | Low RAS activity is described in the protocol | 0 | 10 | 0 | 10 |
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| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |