An interventional study of glucagon-like-peptide-1 and placebo in Type 2 Diabetes, Stroke and Myocardial Infarction, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-10.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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-1)is 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 pancreatic/pituitary 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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 10 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Drug: glucagon-like-peptide-1
Drug: placebo
intravenous infusion of 1.2pmol/kg/min for 7 hours
intravenous infusion of 1.2pmol/kg/min
The acute effect of GLP-1 on glucose uptake in the brain
Time frame: 1 hour
The acute effect of GLP-1 on glucose uptake in the heart
Time frame: 1 hour
The acute effect of GLP-1 on glucose metabolic rate in the brain
Time frame: 1 hour
The acute effect of GLP-1 on intracerebral glucose concentration
Time frame: 1 hour
The acute effect of GLP-1 on lumped constant in the brain
Time frame: 1 hour
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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University of Aarhus