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

NCT ID: NCT01931982

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Microvascular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Victoza

Intervention Type DRUG

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Victoza

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Zander

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Zander, consultant

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Faber R, Zander M, Pena A, Michelsen MM, Mygind ND, Prescott E. 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. Cardiovasc Diabetol. 2015 Apr 22;14:41. doi: 10.1186/s12933-015-0206-3.

Reference Type DERIVED
PMID: 25896352 (View on PubMed)

Other Identifiers

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2012-005013-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

eudraCT: 2012-005013-38

Identifier Type: -

Identifier Source: org_study_id

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