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

June 24, 2014 updated by: Mette Zander, Bispebjerg Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital region
      • Copenhagen, Capital region, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
CFR is measured at baseline and after 10 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Endothelial function is measured at baseline and after 10 weeks of intervention

Other Outcome Measures

Outcome Measure
Time Frame
Changes in HbA1c
Time Frame: Measurements at baseline and after 10 weeks of intervention
Measurements at baseline and after 10 weeks of intervention
Change in fasting C-peptide
Time Frame: C-peptide is measured at baseline and after 10 weeks of intervention
C-peptide is measured at baseline and after 10 weeks of intervention
Change in fasting insulin
Time Frame: Fasting insulin is measured at baseline and after 10 weeks of intervention
Fasting insulin is measured at baseline and after 10 weeks of intervention
Change in fasting glucose
Time Frame: Fasting glucose is measured at baseline and after 10 weeks of intervention
Fasting glucose is measured at baseline and after 10 weeks of intervention
Change in weight
Time Frame: Weight is measured at baseline and after 10 weeks of intervention
Weight is measured at baseline and after 10 weeks of intervention
Change in waist circumference
Time Frame: Waist circumference is measured at baseline and after 10 weeks of intervention
Waist circumference is measured at baseline and after 10 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Mette Zander, consultant, Department of Endocrinology, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eudraCT: 2012-005013-38
  • 2012-005013-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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