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Clinical Trials/NCT01931982
NCT01931982CompletedPhase 4

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

Bispebjerg Hospital1 site in 1 country20 target enrollmentStarted: May 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in coronary flow reserve (CFR)

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
25 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

victoza

Active Comparator

The study is a cross over study. Patients randomised to start with victoza are treated with victoza for 10 weeks. After a wash out period of 2 weeks they cross over to 10 weeks of no treatment

Intervention: Victoza (Drug)

Outcomes

Primary Outcomes

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

  • Change in Endothelial function:(Endothelial function is measured at baseline and after 10 weeks of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mette Zander

MD, PhD

Bispebjerg Hospital

Study Sites (1)

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