- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418288
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Subjects During Hypoglycemia Assessed by Positron Emission Tomography
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.
Study Overview
Status
Conditions
Intervention / Treatment
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. 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Department of pharmacology, Aarhus university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
intravenous infusion of 1.2pmol/kg/min for 7 hours
|
Placebo Comparator: P
|
intravenous infusion of 1.2pmol/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The acute effect of GLP-1 on glucose uptake in the brain
Time Frame: 1 hour
|
1 hour
|
The acute effect of GLP-1 on glucose uptake in the heart
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The acute effect of GLP-1 on glucose metabolic rate in the brain
Time Frame: 1 hour
|
1 hour
|
The acute effect of GLP-1 on intracerebral glucose concentration
Time Frame: 1 hour
|
1 hour
|
The acute effect of GLP-1 on lumped constant in the brain
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ole E Schmitz, MD, DSc, Department of pharmacology, Aarhus university
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Myocardial Infarction
- Infarction
- Diabetes Mellitus, Type 2
- Hypoglycemia
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Glucagon
- Glucagon-Like Peptide 1
Other Study ID Numbers
- 2005-0089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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