The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
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Purpose
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 | Intervention |
|---|---|
|
Type 2 Diabetes Stroke Myocardial Infarction |
Drug: glucagon-like-peptide-1 Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- 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 ]
| Enrollment: | 10 |
| Study Start Date: | January 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: glucagon-like-peptide-1
intravenous infusion of 1.2pmol/kg/min for 7 hours
|
| Placebo Comparator: P |
Drug: placebo
intravenous infusion of 1.2pmol/kg/min
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| Denmark | |
| Department of pharmacology, Aarhus university | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Ole E Schmitz, MD, DSc | Department of pharmacology, Aarhus university |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00418288 History of Changes |
| Other Study ID Numbers: | 2005-0089 |
| Study First Received: | January 3, 2007 |
| Last Updated: | June 9, 2008 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by University of Aarhus:
|
GLP-1 glucose metabolism Type 2 diabetes brain PET |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypoglycemia Infarction Myocardial Infarction Stroke Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Glucagon Glucagon-Like Peptide 1 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Incretins |
ClinicalTrials.gov processed this record on May 19, 2013