The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Stroke; Myocardial Infarction

• Registration Number: NCT00256256
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-16
• Study First Submitted QC: 2005-11-16
• Study First Posted: 2005-11-21
• Study Completion: 2007-01
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
FDG-uptake in the brain and heart visualized by Positron emission tomography with and without GLP-1	After 4 hours of GLP-infusion

Secondary Outcome Measures

Name	Time	Method
Laboratory values (insulin secretion and counter-regulatory hormones)	During 7 hours of clamp and GLP-1/placebo infusion

Trial Locations

Locations (1)

Department of pharmacology, Aarhus university; 🇩🇰 Aarhus, Denmark