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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00256256
First received: November 16, 2005
Last updated: October 29, 2007
Last verified: October 2007
  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 GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert its protective effects.


Condition Intervention
Type 2 Diabetes
Stroke
Myocardial Infarction
Drug: glucagon-like-peptide-1

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: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Laboratory values (insulin secretion and counter-regulatory hormones) [ Time Frame: During 7 hours of clamp and GLP-1/placebo infusion ]

Enrollment: 10
Study Start Date: November 2005
Study Completion Date: January 2007
Intervention Details:
    Drug: glucagon-like-peptide-1
    Dose: 1.2pmol/kg/min for 6 hours
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256256

Locations
Denmark
Department of pharmacology, Aarhus university
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Ole Schmitz, MD,professor Department of pharmacology, Aarhus university
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00256256     History of Changes
Other Study ID Numbers: 2005-0079
Study First Received: November 16, 2005
Last Updated: October 29, 2007
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
type 2 diabetes
GLP-1
PET
brain
heart

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
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
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on August 19, 2014