A Phase 4 interventional study of Liraglutide and Placebo in Diabetes Mellitus Type 2, Diastolic Dysfunction and Cardiac MRI, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.
Aim: To test if treatment with liraglutide a GLP-1 analogue in 18 weeks improves diastolic performance in type 2 diabetes (DM2) patients with diastolic dysfunction, compared to placebo. Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial perfusion.
The investigators find that especially diastolic dysfunction is of interest, because it is highly overrepresented in DM2 patients and no treatment exists. Glucagon-like peptide 1 analogue could be a possible treatment agent, by increasing the energy level in the myocardium. No previous study has tested the effect of treatment with a glucagon-like peptide 1 analogue on diastolic dysfunction.
Design: A randomised double-blinded placebo-controlled clinical trial. Sample size: 40 patients, 20 in each group. The superior inter-study reproducibility results in considerably lower calculated sample sizes (reductions of 55% to 93%) required by cardiac MR compared with echocardiography to show clinically relevant changes. Power calculations show that only 30 patients are needed form our primary outcome, to allow for dropouts the investigators have chosen to include 40 patients.
Intervention: After randomization, patients will be treated with placebo or liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. A cardiac MRI scan and an echocardiography will be preformed at baseline and after 18 weeks.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other concominant disease or treatment that according to investigator's assessment makes the patient unsuitable for participation in the study
Measured twice at visit 0. In case of elevation, an ambulatory (24-hour) blood pressure will be performed, and the result of this will be conclusive
Patients will be treated with liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks.
Drug: Liraglutide
Patients will be treated with placebo (up to equal to 1.8 mg drug dose s.c. once daily). Total treatment period will be 18 weeks. The study will be placebo-controlled with placebo as an add-on to conventional diabetes treatment. Thus, no patient will receive a sub-standard treatment.
Drug: Placebo
Also known as: Victoza
Change in diastolic properties as assessed by CMR.
LA passive emptying fraction (%) (before and after glycopyrolate)
Time frame: Measured in week 18 and compared to baseline.
Change in diastolic properties as assessed by CMR.
LV peak filling rate (ml/s) (before and after glycopyrolate)
Time frame: Measured in week 18 and compared to baseline.
MRI indices of myocardial perfusion
Time frame: Measured in week 18 and compared to baseline.
Echocardiographic indices of diastolic dysfunction
Time frame: Measured in week 18 and compared to baseline.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark