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

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Type 2 Diabetes Microvascular Dysfunction
Intervention	Drug: Victoza
Phase	Phase 4
Sponsor	Bispebjerg Hospital
Responsible Party	Bispebjerg Hospital
ClinicalTrials.gov Identifier	NCT01931982
First Received	August 20, 2013
Last Updated	August 27, 2013
Last verified	August 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 20, 2013
Last Updated Date	August 27, 2013
Start Date	May 2013
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Change in coronary flow reserve (CFR) [Time Frame: CFR is measured at baseline and after 10 weeks of intervention] [Designated as safety issue: Yes]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.
Current Secondary Outcome Measures	Change in Endothelial function: [Time Frame: Endothelial function is measured at baseline and after 10 weeks of intervention] [Designated as safety issue: Yes]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).

Descriptive Information[ + expand ][ + ]

Brief Title	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
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Microvascular Dysfunction
Intervention	Drug: Victoza
Study Arm (s)	Active Comparator: victoza 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 No Intervention: No treatment

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	20
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	February 2014
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 - Atrial fibrillation - Chronic or previous acute pancreatitis - Inflammatory bowel disease.
Gender	Both
Ages	25 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Denmark

Administrative Information[ + expand ][ + ]

NCT Number	NCT01931982
Other Study ID Numbers	eudraCT: 2012-005013-38
Has Data Monitoring Committee	Yes
Information Provided By	Bispebjerg Hospital
Study Sponsor	Bispebjerg Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Mette Zander, consultant Department of Endocrinology, Bispebjerg Hospital
Verification Date	August 2013

Locations[ + expand ][ + ]