Skip to content

Trial · Interventional

CompletedPhase 4Registry data

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

Short name EGOFIP

NCTNCT01931982 (opens ClinicalTrials.gov in a new tab)Other ideudraCT: 2012-005013-38Other id2012-005013-38
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Bispebjerg Hospital · Other
Design
Randomized · Single masking
Countries
1 country

Denmark

Start
May 2013
Primary completion
Apr 2014
Completion
Apr 2014
First posted
30 Aug 2013 (estimated)
Last update posted
25 Jun 2014 (estimated)
Conditions
Type 2 Diabetes · Microvascular Dysfunction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

    EGOFIP

    NCT01931982

    May 2013 to Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • VictozaDrug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in coronary flow reserve (CFR)

    Time frame · CFR is measured at baseline and after 10 weeks of intervention

    Registry description

    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 outcomes(1)

  1. Change in Endothelial function:

    Time frame · Endothelial function is measured at baseline and after 10 weeks of intervention

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

6 results

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.

Faber et al. 2015Cardiovascular diabetologycited by 45

PMID 25896352PMC4407869DOI 10.1186/s12933-015-0206-3PUB-25896352

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.