Endothelial and Metabolic Effects of Glucagon-like Peptide-1 (GLP-1) in Coronary Circulation in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00923962 |
Recruitment Status
:
Completed
First Posted
: June 18, 2009
Last Update Posted
: September 18, 2012
|
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GLP-1 is an incretin hormone which is discharged from the intestines after food intake. The hormone is known for its powerful insulinotropic and trophic effects on the beta cells in the pancreas and is currently used as an anti-diabetic agent in patients with type 2 diabetes (T2DM).
GLP-1 receptors are widely distributed including on the endothelial cells in both coronary and skeletal muscle circulation and on the myocardium. GLP-1-receptor studies on knock-out mice have shown that they exhibit a reduced myocardial contractility and reduced diastolic heart function. GLP-1 also shows beneficial cardiovascular effects in patients with acute myocardial infarctions and dogs with dilated cardiomyopathy in that the left ventricle function and endothelial dysfunction improves after GLP-1 treatment via insulin-independent mechanisms. Preclinical studies indicate that exogenous administrated GLP-1 in physiological concentrations can improve perfusion but this has never been tested in humans. It is also unknown whether GLP-1 can directly increase the glucose/metabolite uptake across both cardiac and skeletal muscle in an insulin independent manner. Unpublished studies do however indicate that the improvement in the cardiovascular system is largely dependent upon a high blood glucose level and only partially dependent upon the antiglycemic effects of GLP-1.
In the proposed studies the investigators wish to examine the physiological role of GLP-1 receptor stimulation both with regard to perfusion, metabolic improvement as well as cardiac inotropic. These studies will be conducted in both healthy and in T2DM patients.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Glucagon like peptide-1 Drug: Adenosine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Official Title: | Endothelial and Metabolic Effects of GLP-1 in Coronary Circulation in Patients With Type 2 Diabetes Mellitus |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Type 2 Diabetes patients |
Drug: Glucagon like peptide-1
0,1 pmol/kg/min
Drug: Adenosine
20-40 microgram/minute
|
Active Comparator: Healthy |
Drug: Glucagon like peptide-1
0,1 pmol/kg/min
Drug: Adenosine
20-40 microgram/minute
|
Active Comparator: Artherosclerosis |
Drug: Glucagon like peptide-1
0,1 pmol/kg/min
Drug: Adenosine
20-40 microgram/minute
|
- Coronary blood flow [ Time Frame: 10 minutes after I.A. GLP-1 ]
- Coronary metabolite uptake [ Time Frame: 10 minutes after I.A. GLP-1 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Caucasians over 18
- Emitted for non-acute coronary arteriography (CAG) in Gentofte hospital
- BMI 23-35 kg/m2
- Normal hemoglobin
- Who gives informed consent
- Those with type 2 diabetes: HbA1c 6-10%
- Those without type 2 diabetes: Normal oral glucose tolerance test (OGTT) according to WHO criteria
Exclusion Criteria:
- Liver disease (ALAT > 2x normal)
- Diabetic nefropati (Creatinine > 130 µM or albuminuria)
- Treatment with medicine that cannot be paused 12 hours before intervention
- Pregnancy or breastfeeding
- Insulin- or glitazone treatment
- Healthy controls: close family history with diabetes
- Unstable angina pectoris
- Non-STEMI
- Atrial fibrillation
- Valvular disease
- LVEF < 50%
- Severe systemic disease
- Type 1 diabetes

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): NCT00923962
Denmark | |
University Hospital Gentofte, Department of Cardiology | |
Gentofte, Denmark, 2900 |
Study Chair: | Jan S Jensen, MD, DMSc | University hospital Gentofte, Department of Cardiology | |
Principal Investigator: | Jaya Rosenmeier, MD, Ph.D. | University hospital Gentofte, Department of Cardiology |
Publications:
Responsible Party: | Jacob Christian Sivertsen, MD, University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT00923962 History of Changes |
Other Study ID Numbers: |
GLP-1 Coronary circulation 01 |
First Posted: | June 18, 2009 Key Record Dates |
Last Update Posted: | September 18, 2012 |
Last Verified: | September 2012 |
Keywords provided by Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen:
Basic science Type 2 Diabetes mellitus Glucagon like peptid-1 Coronary Bloodflow Metabolite uptake |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glucagon Glucagon-Like Peptide 1 Adenosine Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Incretins Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |