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

Type 2 Diabetes Clinical Trial

— EGOFIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931982
• Other study ID #: eudraCT: 2012-005013-38
• Secondary ID: 2012-005013-38
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2013
• Last updated: June 24, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Microvascular Dysfunction
• Type 2 Diabetes

Intervention

Drug:
• Victoza

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Capital region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in HbA1c		Measurements at baseline and after 10 weeks of intervention	No
Other	Change in fasting C-peptide		C-peptide is measured at baseline and after 10 weeks of intervention	No
Other	Change in fasting insulin		Fasting insulin is measured at baseline and after 10 weeks of intervention	No
Other	Change in fasting glucose		Fasting glucose is measured at baseline and after 10 weeks of intervention	No
Other	Change in weight		Weight is measured at baseline and after 10 weeks of intervention	No
Other	Change in waist circumference		Waist circumference is measured at baseline and after 10 weeks of intervention	No
Primary	Change in coronary flow reserve (CFR)	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.	CFR is measured at baseline and after 10 weeks of intervention	Yes
Secondary	Change in Endothelial function:	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).	Endothelial function is measured at baseline and after 10 weeks of intervention	Yes