The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00418288|
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : June 10, 2008
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.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Stroke Myocardial Infarction||Drug: glucagon-like-peptide-1 Drug: placebo|
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.
|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 Brain and Heart in Healthy Subjects During Hypoglycemia Assessed by Positron Emission Tomography|
|Study Start Date :||January 2007|
|Primary Completion Date :||October 2007|
|Study Completion Date :||February 2008|
|Active Comparator: A||
intravenous infusion of 1.2pmol/kg/min for 7 hours
|Placebo Comparator: P||
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 ]
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): NCT00418288
|Department of pharmacology, Aarhus university|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Ole E Schmitz, MD, DSc||Department of pharmacology, Aarhus university|