The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men
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|ClinicalTrials.gov Identifier: NCT00256256|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : October 30, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Stroke Myocardial Infarction||Drug: glucagon-like-peptide-1||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of GLP-1 on Glucose Uptake in the CNS and Heart in Healthy Subjects During Normoglycaemia Assessed by Positron Emission Tomografi|
|Study Start Date :||November 2005|
|Actual Study Completion Date :||January 2007|
- Drug: glucagon-like-peptide-1
Dose: 1.2pmol/kg/min for 6 hours
- FDG-uptake in the brain and heart visualized by Positron emission tomography with and without GLP-1 [ Time Frame: After 4 hours of GLP-infusion ]
- Laboratory values (insulin secretion and counter-regulatory hormones) [ Time Frame: During 7 hours of clamp and GLP-1/placebo infusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256256
|Department of pharmacology, Aarhus university|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Ole Schmitz, MD,professor||Department of pharmacology, Aarhus university|