Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418288
Status:
COMPLETED
Last Update Posted:
2008-06-10
First Post:
2007-01-03
Brief Title:
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Subjects During Hypoglycemia Assessed by Positron Emission Tomography
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type 2 diabetes mellitus T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated New animal studies indicate a protective effect of GLP-1 in the brain and the heart The mechanism behind this is yet not known
The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert protective effects in the brain
The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert protective effects in the brain
Detailed Description:
Type 2 diabetes mellitus T2D is a disease characterized by an immense growing prevalence world wide T2D is associated with a three-fold increase in cardiovascular complications myocardial infarction and stroke leading to significantly higher morbidity and mortality in this group of patients The prospective British Diabetes Study UKPDS showed that neither diet alone nor the pharmaceutical treatment utilized Sulphonylurea Metformin Insulin were able to reduce these macrovascular complications GLP-1 glucagon-like-peptide-1is an incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no risk of hypoglycaemia New research in animal models has shown a potential protective effect in the brain and heart in association with ischaemic damage The mechanism behind this protective effect is not known During hypoglycaemia the brain lacks glucose which is the main fuel for sufficient brain function The brain will compensate by increasing glucose uptake across the blood brain barrier and similarly in the heart
The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by fluoro-deoxy-glucose FDG-PET-scan during hypoglycaemia in healthy men At the same time a pancreaticpituitary clamp will be performed The hypothesis is that GLP-1 directly will stimulate glucose uptake independent of the pancreatic hormones and through this mechanism exert neuro- and cardioprotective actions
Comparisons FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo
The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by fluoro-deoxy-glucose FDG-PET-scan during hypoglycaemia in healthy men At the same time a pancreaticpituitary clamp will be performed The hypothesis is that GLP-1 directly will stimulate glucose uptake independent of the pancreatic hormones and through this mechanism exert neuro- and cardioprotective actions
Comparisons FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None