Myocardial Infarction, Stroke, Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, GLP-1, PET, brain, heart
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 GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert its protective effects.
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-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. 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 normoglycaemia in healthy young 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 its neuro- and cardioprotective actions. Comparisons: FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo.
Interventions
Dose: 1.2pmol/kg/min for 6 hours
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men * Age 20-50 years * Caucasian * BMI 20-30 kg/m2
Exclusion criteria
* Diabetes in subject and 1.degree relatives * Any disease of clinical relevance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FDG-uptake in the brain and heart visualized by Positron emission tomography with and without GLP-1 | After 4 hours of GLP-infusion |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory values (insulin secretion and counter-regulatory hormones) | During 7 hours of clamp and GLP-1/placebo infusion |
Countries
Denmark
Outcome results
None listed