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Completed

NCT Number: NCT01931982

Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.

The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion in the heart of patients with type 2 diabetes

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Microvascular Dysfunction Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea.
  • Age: 25-75 years
  • BMI>25 kg/m2
  • HbA1c 6,0-10 %

Exclusion criteria

  • Current treatment with insulin or Dipeptidyl peptidase IV inhibitor.
  • Haemoglobin < 6.5 mmol/l
  • Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study.
  • Allergy towards victoza ® (liraglutide ), Dipyridamol, Nitroglycerin or rescue medicine: Theophyllin
  • Pregnancy
  • Severe asthma
  • Active cancer
  • Severe co-morbidity with limited life-expectancy
  • Estimated glomerular filtration rate (eGFR) <60 (measured at baseline)
  • Severe hepatic co-morbidity
  • Chronic alcohol abuse
  • Heart failure with a left ventricular ejection fraction </= 45%
  • Atrial fibrillation
  • Chronic or previous acute pancreatitis
  • Inflammatory bowel disease.

Treatment and study plan

Victoza

Drug

Primary outcomes

  1. Change in coronary flow reserve (CFR)

    Time frame: CFR is measured at baseline and after 10 weeks of intervention

    CFR can be reliably assessed non-invasively by trans-thoracic Doppler flow echocardiography of the left anterior descending artery with a success rate of over 90% even in an obese population with a relative poor acoustic window. CFR is the ratio of flow during stress to during rest.

Secondary outcomes

  1. Change in Endothelial function:

    Time frame: Endothelial function is measured at baseline and after 10 weeks of intervention

    Measurement of Peripheral Arterial Tone, with the use of the commercially available machine (Endo-PAT2000®) assesses the control of digital vascular tone by the sympathetic nervous system and nitric oxide (NO).

Other outcomes

  1. Changes in HbA1c

    Time frame: Measurements at baseline and after 10 weeks of intervention

  2. Change in fasting C-peptide

    Time frame: C-peptide is measured at baseline and after 10 weeks of intervention

  3. Change in fasting insulin

    Time frame: Fasting insulin is measured at baseline and after 10 weeks of intervention

  4. Change in fasting glucose

    Time frame: Fasting glucose is measured at baseline and after 10 weeks of intervention

  5. Change in weight

    Time frame: Weight is measured at baseline and after 10 weeks of intervention

  6. Change in waist circumference

    Time frame: Waist circumference is measured at baseline and after 10 weeks of intervention

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2

Acronym: EGOFIP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2013
Registry last updated
Jun 25, 2014

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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