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NCT Number: NCT00923962

Endothelial and Metabolic Effects of Glucagon-like Peptide-1 (GLP-1) in Coronary Circulation in Patients With Type 2 Diabetes Mellitus

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 Unpublished studies do however indicate that the improvement in the cardiovascular system is largely dependent upon a high blood glucose level and only partially dependent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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Gentofte, Department of Cardiology

Gentofte Municipality, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucagon like peptide-1

Drug

0,1 pmol/kg/min

Adenosine

Drug

20-40 microgram/minute

Primary outcomes

  1. Coronary blood flow

    Time frame: 10 minutes after I.A. GLP-1

  2. Coronary metabolite uptake

    Time frame: 10 minutes after I.A. GLP-1

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Endothelial and Metabolic Effects of GLP-1 in Coronary Circulation in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2009
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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