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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931982
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Mette Zander, Bispebjerg Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Microvascular Dysfunction Drug: Victoza Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2
Study Start Date : May 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Victoza
No Intervention: No treatment


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931982


Locations
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Denmark
Bispebjerg Hospital
Copenhagen, Capital region, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Mette Zander, consultant Department of Endocrinology, Bispebjerg Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mette Zander, MD, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01931982    
Other Study ID Numbers: eudraCT: 2012-005013-38
2012-005013-38 ( EudraCT Number )
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by Mette Zander, Bispebjerg Hospital:
diabetes, GLP-1, Victoza, CFR, microvascular dysfunction
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists