Clinical trial NCT01931982: Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.
Official title: Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Microvascular Dysfunction
Keywords: diabetes, GLP-1, Victoza, CFR, microvascular dysfunction
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in coronary flow reserve (CFR)
timeFrame: CFR is measured at baseline and after 10 weeks of intervention
Secondary outcomes:
measure: Change in Endothelial function:
timeFrame: Endothelial function is measured at baseline and after 10 weeks of intervention
Other outcomes:
measure: Changes in HbA1c
timeFrame: Measurements at baseline and after 10 weeks of intervention
measure: Change in fasting C-peptide
timeFrame: C-peptide is measured at baseline and after 10 weeks of intervention
measure: Change in fasting insulin
timeFrame: Fasting insulin is measured at baseline and after 10 weeks of intervention
measure: Change in fasting glucose
timeFrame: Fasting glucose is measured at baseline and after 10 weeks of intervention
measure: Change in weight
timeFrame: Weight is measured at baseline and after 10 weeks of intervention
measure: Change in waist circumference
timeFrame: Waist circumference is measured at baseline and after 10 weeks of intervention
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Capital region
Study officials:
affiliation: Department of Endocrinology, Bispebjerg Hospital
name: Mette Zander, consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faber R, Zander M, Pena A, Michelsen MM, Mygind ND, Prescott E. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes - a randomized, single-blinded, cross-over pilot study. Cardiovasc Diabetol. 2015 Apr 22;14:41. doi: 10.1186/s12933-015-0206-3.